Graduate Courses

In this introductory course, participants will learn about the cultural history of medical cannabis use, explore how federal law and policy relating to medical and non-medical use of cannabis has evolved in the United States, and discuss ethical issues related to medical cannabis. Additionally, students will learn how to identify credible sources of online information related to medical cannabis.

This course introduces students to the factors influencing drug action in the body. Students will learn about receptor theory, pharmacokinetics, pharmacodynamics, dose-response relationships, and drug tolerance and dependence. This course will develop participants’ skills to evaluate cannabis (and its components) from a mechanistic and pharmacologic perspective with the ultimate goal of providing the most appropriate cannabis regimen for individual patients.

This course introduces students to the chemical characteristics of cannabis components. The course will describe the classification system for cannabinoids, cannabinoid compound ratios in plant materials, cannabis-derived products and their constituents, oils, terpenoids, flavenoids, hydrocarbons and nitrogen containing compounds. This course also introduces students to the science of designing dosage forms. Topics include the formulation, development, evaluation, selection and administration of safe, effective, reliable, drug delivery systems, with a focus on development of medical cannabis products. The wide variety of cannabis delivery systems and routes of delivery and the impact of those delivery systems have on the bioavailability of cannabis will be evaluated in this course.

This introductory course provides an overview of patient care skills including communication and cultural competence. The course also introduces students to evidence-based medicine and how to apply EBM to therapeutic questions. Students will learn about medical cannabis dosing strategies, administration, and educating patients about medical cannabis side effects, precautions, and drug interactions. Special populations are also discussed.

In this advanced level course, students will learn in-depth about the physiology, pathophysiology, and treatment strategies of selected conditions, including pain, muscle spasm, nausea/vomiting, and anorexia/cachexia. Students will evaluate available evidence, complete case studies, and explore dosing strategies and formulations. Side effects, drug interactions, and precautions are also discussed. (Pre-requisite: MCST 604 – Clinical Effects of Cannabis).

In this course, students will dissect the latest evidence about cannabis to explore cannabis’s place in therapy for the treatment of psychiatric and neurological disorders. Students will learn about the physiology, pathophysiology, and evidence-based treatment strategies for psychosis, anxiety, post-traumatic stress disorder, insomnia, mood disorders, epilepsy, and autism spectrum disorder. Students will be equipped with the tools necessary to find, interpret, and apply the cannabis-based literature. The evidence-based medicine objectives will be interspersed through each module and continue to build upon each other in various assignments as the course progresses. Students will learn how to clearly articulate the reasoning behind clinical decision making as they complete case studies where they discuss side effects, drug interactions, precautions, dosing strategies, and formulations. NOTE: This course is not a continuation of MCST 605 (Advanced Cannabis Therapeutics for Somatic Conditions) and may be taken independently of MCST 605. (Pre-requisite: MCST 604 – Clinical Effects of Cannabis).

In this course, students will explore the consequences of cannabis use, including adverse effects and misuse or addiction. Students will evaluate available evidence, analyze case studies, and participate in group discussions. This course explores the effects of cannabis on populations, including effects on the workplace, public spaces, impaired driving, adolescent use, and unintentional poisoning, among others.

This course introduces students to the components of the cannabis plant and the resultant biosynthetic pathways that form active and inactive agents. Students will learn the genetic basis for the differences in components between different strains and the subsequent impact on medicinal efficacy, as well as the role that plant components have on the entourage effect. (Pre-requisite: MCST 602 - Principles of Drug Action and Cannabinoid Pharmacology).

This course relates chemical characteristics of cannabis components to their pharmacological activity. The course covers a variety of cannabis targets, methods for improving drug activity, and the principles of rational drug design and characteristics such as solubility, stability and metabolism. Additionally, this course will explore methodologies for concentration, extraction, and purification of plant constituents, along with scope and limitations of analytical techniques for the identification and quantification of plant and synthetic cannabinoids, contaminants, and adulterants in cannabis products. (Pre-requisite: MCST 603 - Basic Cannabinoid Chemistry and Delivery).

This course introduces students to the constantly evolving field of cannabis regulation that spans federal, state, and local government.  To better understand this complex system, students will first learn about key aspects of constitutional law that shape cannabis regulation. Once this foundation is established, the course will explore the federal regulation of cannabis and the Controlled Substances Act; state legalization trends and the policy issues states must address; the regulation of cannabis businesses, health care providers, patients, and cannabis products; social equity initiatives; and the regulation of industrial hemp production and its derivative products.  In addition to these substantive areas, student will learn how to track and analyze state legislation to remain current on developments in this legal field. (Pre-requisite: MCST 601 - Introduction to Medical Cannabis History, Culture, and Policy).

In this course, participants will develop the foundational knowledge and skills involved in designing clinical research related to medical cannabis. Students will learn and apply the skills of generating a medical cannabis clinical research question, performing a literature review to identify gaps in knowledge, selecting an appropriate corresponding study design, describing essential statistical concepts, and applying key ethical principles and best practices in research. In addition, students will apply clinical research concepts specifically to the unique real-world challenges inherent in designing and conducting high-quality clinical research with cannabis. By the end of the course, students will have developed a mock cannabis clinical research proposal suitable for further development into a formal proposal and have a deeper understanding of the complex legal, social, and economic factors involved and affected by cannabis research activities. This course focuses heavily on the skill of medical and professional writing, and the assignments for the cumulative research project involve weekly writing prompts in addition to quiz-based knowledge assessments.

In this course, students will participate in two symposiums that will include seminars and activities exploring current scientific, clinical, and legal issues related to medical cannabis.  After each symposium, students will reflect on what was learned from the different presentations/experiences, how the knowledge gained relates to what has been learned so far in the MCST program, and how the knowledge can be applied in practice.

Students will participate in one symposium that will include seminars and activities exploring current scientific, clinical, and legal issues related to medical cannabis.  After the symposium, students will reflect on what was learned from the different presentations/experiences, how the knowledge gained relates to what has been learned so far in the MCST program, and how the knowledge can be applied in practice. Additionally, students will work with a group of peers and an organization/client to identify a knowledge gap and design an educational intervention.

 In this course, students will complete the instructional design project that was started in MCST 614 (Medical Cannabis Capstone 1), working with an organization/client to identify a knowledge gap and design an educational intervention. Additionally, students will create a professional portfolio to showcase the work completed as part of the MS in Medical Cannabis Science and Therapeutics program.

This elective course explores the factors that influence health outcomes of individuals and populations and introduces skills necessary to be an effective medical cannabis policy analyst or policy advocate. This course examines the ways in which different disciplines inform the development, implementation and analysis of health policies. Students will learn how policymakers interact, and how outside influences such as the media and advocates help shape policy. (Pre-requisite: MCST 601 Introduction to Medical Cannabis History, Culture, and Policy).

In this course, students will examine the fundamental concepts of integrative health and wellness (IHW), including the history, philosophies, and methods of prominent integrative therapies. Perceived differences between and limitations of traditional “allopathic” medicine and IHW “nontraditional” medicine will be identified. Patients’ motivations and patterns of use of IHW approaches will be explored. Components of the five major areas within IHW as identified by the National Institutes of Health will be introduced. These include alternative medical systems, body-based systems (massage, chiropractic, rolfing), mind-body medicine, biological approaches (herbal medicine, nutritional approaches, pharmacological therapies, Ayurveda), and bioelectromagnetics (energy healing). The state of basic scientific knowledge and data from controlled trials relating to the safety, efficacy, and mechanisms of action of integrative therapies are presented. In the second half of the course, an overview of the scientific evidence for the integrative biological and body-based approaches will be provided. Theories for how these approaches function to affect health are examined, such as psychoneuroimmunology, the role of inflammation, and the gut microbiome. Key practice, legal, and ethical issues facing CAM researchers and practitioners are reviewed, as well as future directions in IHW. (Pre-requisite: MCST 604 – Clinical Effects of Cannabis)

This course provides an overview of the science and therapeutic uses of psychedelic agents, with a focus on hallucinogens, hypnotics, empathogens, and entheogens. The course includes historical use, current laws and policies, pharmacological and chemical properties, and the current state of the evidence for therapeutic use. (Pre-requisites: MCST 602 Principles of Drug Action and Cannabinoid Pharmacology, MCST 603 Basic Cannabinoid Chemistry and Drug Delivery, and MCST 604 The Clinical Effects of Medical Cannabis).

An introductory course, participants will learn about the patient/family-centric model of palliative care, the interdisciplinary team concept, models of care in hospice and palliative care and regulatory aspects of these practice models. Participants will also learn about education and self-care for practitioners, operational aspects of hospice and palliative care, the application of analytic inquiry and evidence-based discovery, and implications for community outreach.

This course provides participants with a solid grounding in the principles of adult learning, how to assess knowledge and learning differences, principles of instructional design, and barriers to teaching and learning. Participants will be prepared to perform an audience analysis, prepare and deliver learning materials to patients, families, caregivers, other health care providers, and other stakeholders.

A key element of this course is determining patient and family goals, preferences and choices during advanced illness, and developing a plan of care to support these decisions. A significant portion of this course will also be devoted to communication techniques including delivering bad news, counseling techniques and introductory content on ethical decision-making.

Participants in this course will learn how to assess and address psychological, psychiatric, cultural and spiritual aspects of care in advanced illness, including management of grief and bereavement. Implementation of care plan tactics will be addressed as well including targeted communication, interventions and referrals as needed.

Pain management is the most prevalent symptom in advanced illness. Participants will learn how to perform a uni- and multi-dimensional pain assessment, and the assessment of the most common non-pain symptoms associated with advanced illness. Management strategies including non-pharmacologic and pharmacologic will be examined. A case-based learning model will be used in this course to master content, including demonstration of information literacy and quantitative fluency.

Hospice and palliative care professionals are at high risk for burnout. Participants in this course will learn about common sources of stress in this field, what self-care is, and why healthcare professionals should practice self-care. Participants will learn several techniques to practice daily self-care.

Participants in this course will develop advanced skills used to manage special populations with advanced illness including pediatrics, geriatrics, palliative care emergencies, advanced assessment and management skills to facilitate withdrawal of life-sustaining treatments, and manage the days before death. (Pre-requisite: PALC 605 – Symptom Management in Advanced Illness).

This course addresses the development of hospice leadership skills including developing a supportive culture, mission and values, promoting team building, quality improvement initiatives, service and performance excellence, assuring appropriate staffing, operational aspects, financial management, human resources management, quality management, organizational integrity and compliance. Participants will be intimately knowledgeable about the standards and regulations for hospice eligibility and compensation models. (Pre-requisite: PALC 601 – Principles and Practice of Hospice and Palliative Care).

This course addresses the development of palliative care leadership skills including developing a supportive culture, mission and values, promoting team building, quality improvement initiatives, service and performance excellence, assuring appropriate staffing, operational aspects, financial management, human resources management, quality management, organizational integrity and compliance. Participants will be intimately knowledgeable about the standards and regulations for palliative care practice and compensation models. (Pre-requisite: PALC 601 – Principles and Practice of Hospice and Palliative Care).

Participants in this course will learn to assess the need for a hospice and/or palliative care program, and develop, implement and maintain an ongoing data driven process that reflects the complexity of the organization and focuses on clinical, economic and humanistic outcomes. Learners will assure strategic alignment of program operationalization with established organizational mission and vision with consideration for growth. (Pre-requisite: PALC 601 – Principles and Practice of Hospice and Palliative Care).

This course prepares participants to perform advanced assessment of patients with complex non-pain symptoms, developing advanced skills to identify pathogenesis of the complaint, and advanced non-pharmacologic and pharmacologic management of symptoms. Participants will develop advanced skills in managing these symptoms through the interdisciplinary team. (Pre-requisite: PALC 605 – Symptom Management in Advanced Illness).

Using a disease-based approach, participants will perform advanced assessment of common advanced illness disease states (e.g., COPD, cancer, neurodegenerative disorders, heart disease, etc.), sophisticated identification of pathogenesis and disease progression, selection of beneficial evidence-based treatments, and skills to discontinue medically futile treatments as disease progresses. (Pre-requisite: PALC 605 – Symptom Management in Advanced Illness).

This course provides participants with advanced skills and information necessary to elicit patient and/or family values and delineate goals of care regarding pain and symptom management, advanced life-sustaining therapies, and advanced communication techniques for delivering bad news, establishing goals of care, suspending therapies, and death notification. (Pre-requisite: PALC 603 - Communication and Health Care Decision Making).

Participants will develop advanced skills in the assessing patients and families to determine psychosocial needs, spiritual and cultural concerns, and address patient and family suffering, coping and healing within the emotional, psychological and social domains with focused developmentally appropriate assessment followed by targeted communication, interventions and referrals. (Pre-requisite: PALC 604 - Psychosocial, Cultural, and Spiritual Care).

Participants will learn to perform an advanced assessment of a pain complaint (history, physical exam, diagnostics/imaging as necessary) and demonstrate advanced and in-depth knowledge of the pathogenesis of pain. Participants will also acquire in-depth knowledge of evidence-based non-pharmacologic management of pain, and evidence-based advanced pharmacology (including drug therapy selection, dosing, monitoring, and titration), designed to meet patient-centric therapeutic goals. (Pre-requisite: PALC 605 – Symptom Management in Advanced Illness).

This course is entirely case-based, and uses the interprofessional/interdisciplinary approach to the resolution of complex cases of patients with advanced illnesses. Participants will have to rely on team members to achieve optimal patient outcomes. (Majority of coursework must be completed).

The purpose of this course is to facilitate learners in developing skills to identify, evaluate, and apply palliative care literature per the principles of evidence-based practice. The course will introduce research design and statistical methods to allow students to accurately and effectively interpret study findings. Research designs discussed will include descriptive studies, randomized controlled trials, systematic reviews, clinical practice guidelines, qualitative research, and quality improvement. Learners will be able to appraise literature and apply the evidence to a patient care situation or population of interest.

Participants will explore the history of 20^th century health care and how a rejection of the prevailing paradigms of that era led to the hospice movement. They will trace the early growth of hospice care in the United States culminating in the Medicare Hospice Benefit. They will learn about the early concepts of palliative care and the movement to transform it into a subspecialty for physicians, nurses, social workers, chaplains, and pharmacists. Leadership with clear vision to motivate and inspire others to achieve quality care, build healthy work environments, has led to new models of palliative care. Finally, participants will explore the strengths and weaknesses of the current environment of hospice and palliative care, and based on lessons learned during this evolution they will propose a more effective system of care for those near the end-of-life.

Qualitative and quantitative research in palliative care involves applying many statistical principles. This introductory level statistics course will cover both descriptive and inferential statistics. The students will be able understand the hypothesis testing concepts used in design and analysis of clinical trials. They will also be introduced to regression methodologies for continuous and categorical outcomes which form the basis for palliative care research. GraphPad Prism software would be used to demonstrate the application of statistical aspects. Simulated and real data from experiments and clinical trials will be employed for practice and homework.

Participants in this course will develop proficiency in engaging in critical appraisal of research in the field of palliative care. This course addresses foundational competencies for generating pertinent research questions and conducting academic reviews to facilitate participants contribution to the body of knowledge within palliative care.

This course will inform learners about essential measurement and design aspects of quantitative research, including challenges of designing rigorous studies within the context of palliative care. Using the principles of measurement theory, students will be able to operationalize variables and quantify them into different levels of measure. Students will further demonstrate knowledge on how to evaluate measurement quality, including strategies for assessing instrument reliability and validity. With a conceptual backdrop of probability theory and the causal model, students will learn and apply information about cross-sectional, longitudinal, and group study designs, and critically examine the strengths and weaknesses of a variety of sampling approaches. Students will also be able to identify potential design limitations, such as common sources of error, and threats to internal and external validity. Ethical considerations and attention to issues of health disparities will be infused throughout the course and within student assignments.

This course emphasizes a constructivist approach to the generation of new knowledge in the field of palliative care. Qualitative approaches such as phenomenology, grounded theory, ethnography, focus groups, narrative research, and others are highlighted. The ontological and epistemological underpinnings of each method will be reviewed as well as pragmatic approaches to recruitment, data collection, data analysis, and interpretation of results. Ethical considerations of qualitative research, particularly in relation to vulnerable populations, are stressed.

Person-centered outcomes research seeks to integrate the perspective of patients, their care partners and family, and other stakeholders in the design and conduct of palliative care research. In this course, students will gain the knowledge and skills to design and conduct palliative care research that is meaningful and important to people experiencing serious illness. Emphasis will be placed on current recommendations for the best practices in person-centered outcomes research including the strengths and limitations of common study designs; unique study participant issues; the selection of relevant outcome measures; and implementation and dissemination.

Participants will be required to demonstrate advanced instructional design skills in the areas of analysis, course design, implementation and evaluation. Participant will be required to prepare and present a minimum of four course designs based on four discrete teaching methodologies. Each course will include advanced approaches for four different populations and content.

This course in Leading Change requires intellectual curiosity and commitment to learning theoretical foundations of leadership in palliative care. Palliative care leadership includes leadership in various domains: administration of new programs, initiatives related to serious illness, promotion of excellence and evidence-based practice, research to grow and mature the evidence, policy and advocacy in regulatory issues, health care delivery, and education. This class will examine leadership theory and principles, differences between management and leadership, followership, influence, and power. A case study based approach will be used to examine leadership approaches in palliative care settings in the community and acute care settings. The goal of the course is to empower learners to strategically lead palliative care into the future.

This course is designed to provide guidance, support and mentoring to the PhD degree candidate throughout the dissertation process. Learners will make an original contribution to the scholarship of palliative care demonstrating the doctoral student's ability to research an important question in the field and capacity to present and interpret research findings in a clear and logical written form. Learners in this course will complete institutional requirements for engaging in academic research to include at minimum submission of a completed IRB application to the University Institutional Review Board for Human Subjects research (IRB). The dissertation is completed under the supervision of a faculty Chair and is formally presented in an oral presentation to the Dissertation Committee.

This course is an introduction to the field of pharmacoepidemiology that uses quantitative research methods to examine questions of benefit or risk in regard to the use of marketed medications. The course is intended to offer useful techniques to medical and health researchers who wish to assess the utilization, effectiveness, and safety of marketed drug therapies. Prerequisite: Introduction to Biostatistics and Principles of Epidemiology.

This course provides an overview of comparative effectiveness and patient-centered outcomes research (CER-PCOR) geared toward clinicians and covers a wide range of topics including CER-PCOR history, definitions, and evolution of key terms. The course also covers identifying and engaging stakeholders; evidence-based medicine; current policy issues; government and private sector roles and programs; PCORI, AHRQ, NIH, HHS, and FDA programs; CMS and private insurer uses; patient engagement and advocacy; and application to clinical decision-making.

An examination of the principle components of the US health care system with special emphasis on their relationship to the provision of drugs and pharmacy services.

This course covers medical sociology, psychology, social psychology, and interpersonal communication theories and research as they address medicine use and health-related behaviors involving patients, pharmacists, physicians, nurses, and other health care professionals. Students are acquainted with select health behavior theories and learn about research issues specific to the field of behavioral science.

This course focuses on: (1) advanced analytical methods used in comparative effectiveness research (CER) and pharmacoeconomics studies, (2) the identification and assessment of uncertainty in CER and pharmacoeconomic studies, and (3) the development of a statistical analysis plan for CER and pharmacoeconomics studies.

Health education is a scientific process designed to achieve voluntary behavioral changes to improve health status. Health promotion utilizes health education to promote health and prevent disease. The PRECEDE Model is used to demonstrate the analytical process to explore health problems, identify and assess the behavioral and non-behavioral factors associated with them in order to develop and evaluate interventions. This course addresses health education at the level of the individual, the family and the community at large. Because the relationship between practitioner and patient is often a major determinant of outcome, health promotion in the clinical setting is given emphasis. Cross-listed with PREV 650.

This course is designed to introduce the student to the concepts of scientific research in pharmacy practice and administrative science. Topics to be discussed include the scientific method and problem solving processes, social science measurement, and several specific methods of research. (Corequisite: Introduction to Biostatistics)

This course provides an overview of comparative effectiveness and patient-centered outcomes research (CER/PCOR) covering a wide range of topics including history, definitions, and evolution of key terms. Additional topics include: identifying and engaging stakeholders; evidence-based medicine and health technology assessment; current policy issues; government and private sector roles and programs; PCORI, AHRQ, NIH, HHS, FDA, programs; CMS and private insurer uses; the role of cost/QALY; patient engagement and advocacy; evolving methods and standards resources; and methods and policy controversies.

This course provides an informative overview of healthcare quality improvement through an evaluation of quality and quality measures in varying aspects of healthcare and healthcare services.

This course provides an understanding of the principles for measurement of health and health outcomes. Students will gain a familiarity of various measurement types (e.g., COA, PRO, ObsRO, ClinRO, PerfO), and measurement instruments used for health status, quality of life, patient satisfaction, function and disability, and will become familiar with compliance/adherence and their related properties. Also presented in this course are data sources used for measure development; methods for assessing strengths and weaknesses; validity and reliability, and a framework for judging the appropriateness of a particular measure.

Students are given the opportunity to work with a faculty member on individual and specialized projects/research. The project/research provides students direct experience of collection, organization, and analysis of data.

A weekly seminar involving graduate students, department faculty and participants from outside of the department. Must be taken every semester enrolled as a full-time student.

The purpose of this course is to engage students in the techniques of pharmacoepidemiology through case studies and by working through an actual drug safety investigation. Drug safety is addressed in the context of science and the law through readings, debates, and discussions with invited guests. Using the FDA’s Adverse Event Reporting System database and the medical literature, students devise the epidemiological characteristics of a drug safety signal. Based on the characteristics of the signal, the team designs a pharmacoepidemiological study to further evaluate the safety signal. This course is cross-listed as PREV 722. (Prerequisites: PREV 600, PREV 620, and PHSR 704 or permission of the instructor.)

Required enrollment for students engaged in master’s thesis studies.

This interdisciplinary course describes the inter-relationship among the disciplines of the pharmaceutical sciences, and establishes the basic theoretical background essential to the drug design and development process. A progression of pharmaceutical sciences content is presented and considers the drug discovery process, beginning with traditional drug design and optimization of drug structure, continuing with principles of pharmacology, including macromolecular structure, followed by modern drug discovery methods based on knowledge of the structure and pharmacology of the target molecule.

This interdisciplinary course describes the inter-relationship among the disciplines of the pharmaceutical sciences, and establishes the basic theoretical background essential to the drug design and development process. Built on material presented in PHAR 600 Principles of Drug Discovery, the course covers the areas of pharmaceutics, biopharmaceutics, pharmacokinetics, and drug metabolism. Integrative competency is developed and demonstrated in the final module.

This lab course builds on the principles of chemistry, biochemistry, and biology. The course covers basic lab techniques, instrumentation, as well as key databases and software.

This course emphasizes experimental design and is intended to build on practical skills learned in Experimental Success 1: Laboratory Skills (PHAR 606). The course will expose students to five experimental techniques in pharmaceutics, then challenge them to design an experimental plan that uses each technique to address a practical problem. While each technique is used in the laboratory of a faculty member associated with pharmaceutics, the learned skills will be relevant to all Pharmaceutical Sciences masters students.

This course addresses the rational design and formulation of dosage forms, and the processes and equipment in their large scale manufacture. Consideration is on how the interplay of formulation and process variables affects both the manufacturability of the dosage form and its performance as a drug delivery system.

Recent decades have seen many examples of challenges to ethics in scientific research. With the goal to provide contemporary and complete training in research, this course will expose students to acceptable and unacceptable ethical behaviors. To help understand the issues and aid discussions, this course will be heavily case-based. Students will also gain training in appropriate experimental design and ways of conducting experiments and analyzing data. They will learn to identify ethical issues in a practical sense by critical review of manuscripts. This course will be offered to graduate students and Pharmacy students. Moreover, a basic understanding of statistical analyses is an essential complement to proper experimental design and data analysis. Knowledge gained will be considered an integral component of their research training in the pharmaceutical sciences.

This course focuses on physical aspects of the structure and function paradigm of biological and pharmaceutical molecules. It is designed for both experimentally and theoretically/computationally oriented graduate students in pharmaceutical, chemical, biochemical and medical sciences. This course offers student’s exposure to basic theories and computational methods for studying the mechanisms of biological systems at an atomic level of detail.

Interindividual variability in drug effects and the lack of reliable prediction of this variability have been recognized as major barriers to safe and efficient therapeutics. Genetic makeup is one of the intricate factors that has substantial influence on drug efficacy or toxicity. Pharmacogenomics deals with hereditary and effects on drug response. It combines traditional pharmaceutical sciences with contemporary knowledge of genes, proteins and SNPs. The objective of this course is to enable the student to understand basic pharmacogenomic principles, and their potential use for developing better and safer drugs.

This course describes current techniques and strategies for isolating, detecting and analyzing experimental data. Topics range from methods relevant to small molecules to tissues and cells to whole animals.

This course introduces students to spectrometric techniques for the elucidation of molecular structure and to the analysis of pharmaceutically important materials. The methodologies covered include ultraviolet-visible, infrared, nuclear magnetic resonance, and mass and fluorescence spectrometry. The class includes discussions of physical principles, instrumentation involved, exercises in the interpretation of spectrometric data, and examples of application.

This course will provide a platform for developing technical writing skills focused on identifying common components of academic writing and creating best practice guidelines. Students will be exposed to articles, visualizations, and software to prepare them for writing in their careers. Students will be challenged to review and breakdown academic literature. They will also lead discussions on effective methods of communication. Exercises from this course will build the foundational skills necessary to succeed in PHAR 642 Technical Writing “Chapter II”.

This course will act as a stage for students to develop their technical writing skills with a focus on academic publication. Students will be exposed to articles, visualizations, and software to prepare them for writing in their careers. Content for class will focus on identifying common components and structure of academic literature, style, writing behavior, and revision. Students will work collaboratively through writing and review sessions to construct quality written works. Exercises from this course will build the advanced skills required to write high level academic documents. Students taking this course will work to create documents that meets the general requirements for publication.

This course will provide a platform for developing data analytics and coding skills focused on solving real world data science problems in the pharmaceutical field. Students will be exposed to analytics, visualization, and coding tools to prepare them for creating their own programs and solving unique problems. Students will be challenged to create simple programs to analyze large data sets, organize data, visualize data, and identify trends or outcomes from the data. Knowledge and skills from previous courses throughout the program will be utilized to answer questions brought forth in this course.

Clinical pharmacology plays a critical role in drug development - in part by evidence of the “Clinical Pharmacology” section in the labeling of drugs in the US. Clinical pharmacology is a translational discipline that informs the how drugs can best be used. This course is designed to orient students to several types of clinical pharmacology studies in drug development, as well as their underlying principles. Studies include: first-in-human studies; food effect studies; bioavailability studies; bioequivalence studies; drug-drug interaction studies (e.g. enzyme-based inhibition and induction studies, as well as transporter-based studies); and effect of hepatic or renal impairment studies. Variables such as age (e.g. pediatric and geriatric) and race/ethnicity (e.g. ICH E5 ethnic factors in the acceptability of foreign clinical data) are also featured. 

Provides students with an understanding of the recent progress in basic and clinical pharmacology research, from new concepts in pharmacology to the new techniques and trends in pharmacology.

This course provides a foundational understanding of bacterial physiology, with a focus on how antibiotics target these processes as well as the mechanisms used by bacteria to mediate antibiotic resistance and tolerance. Students will also be introduced to basic microbial pathogenesis themes in the context of anti-infective drug discovery. Students will be expected to read and discuss assigned articles that are related to our current understanding of antibiotic resistance, tolerance, and discovery.

Students are taught the application of synthetic organic chemistry to drug design. The course includes instruction in a range of standard functional group transformations and chemical mechanisms. Discussion then shifts to apply this synthetic chemistry knowledge to the synthesis of peptides, peptoids, small-molecules and natural products. Protecting group chemistry as well as solid phase synthesis are also discussed.

This 1-credit, 1-module on-line course teaches students the fundamental concepts of process analytical technologies (PAT) for pharmaceutical manufacturing. Content includes introduction to pharmaceutical manufacturing, quality systems, and PAT, followed by lectures on the principles and applications of specific PAT, covering both process monitoring and product inspection.

This course provides students with the opportunity to participate in a multi-month (up to 6 months) biopharmaceutical research internship. The goal of the internship is to provide an immersive research experience during which the student develops the skills needed to pursue a career in biopharmaceutical research. Students will learn how to (1) develop a research project (2) analyze and think critically about research data, (3) present research results in different settings (e.g team, one-on-one, etc), (4) work in a professional environment, (5) develop networking and interpersonal skills and (6) acquire skills for job preparation.

This course provides students with the training and tools to conceive, plan and manage a biopharmaceutical research project for a short term research experience (Biopharmaceutical Research Experience). Students will learn how to (1)  identify the research problem to be investigated; (2) conduct a comprehensive literature search to understand the field; (3) define the research hypothesis to be tested; (4) conceive the project’s specific aims; (5) plan out the experimental approach; (6) determine the project timeline and (7) manage the project’s progress.

The capstone project is designed to be a supervised cumulative experience that brings together the findings from the student’s ‘Research Project Design and Management’ and ‘Biopharmaceutical Internship’ courses and applies them to the completion of a written capstone project. The capstone will be written in the form of a journal article that follows the style and length specifications of the chosen journal. Students will learn how to (1) select an appropriate journal to write the capstone and identify the journal’s style guidelines, (2) outline the capstone article, (3) identify appropriate scientific papers to reference in the capstone, (4) prepare publication quality figures and tables, (5) write an editable draft of the capstone, (6) respond to feedback and critiques on the draft from a ‘reviewer,’ (7) complete a publication quality, final capstone article.

MS students in the PSC program will organize the data they have obtained during their internship period and present it in the form of a poster. Students will draw from their research design and planning course, their internship research and their capstone project in their poser presentation. The poster will be presented at a departmental seminar attended by their mentors and PSC and external researchers.  Students will also be required to evaluate and provide critiques on other student posters, thereby learning how to assess other scientific work.  

This course is designed as a forum for students to present research projects to a peer audience and to help students thoroughly disseminate, analyze, and critique current research related to the pharmaceutical sciences. Students will be introduced to interdisciplinary research topics. Journal discussions with be coordinated with department seminar speaker’s research interests.

This course will provide basic knowledge about drug absorption at different sites in the human body (e.g., intestine, blood-brain barrier, kidney, liver) and the physicochemical and pharmaceutical factors, as well as pathophysiologic conditions, that influence drug penetration. This course will allow the students to understand the choice of a particular absorption route and dosage form. Furthermore, the interplay of drug metabolism and drug transport will be discussed.

Students orally present and critically review the progress and findings that are related to their research project.

Applications of chemical and biological principles to the rational design of drugs. Topics include targets of biologically active molecules, approaches to studying ligand and target interactions, overview of drug discovery, agents acting on specific targets, combinatorial chemistry, computation chemistry, and structure activity relationships.

This course introduces basic concepts pertaining to metal ions in biological systems. Topics include metal ions in proteins, cofactors and metal clusters, metal ion transport and storage and regulation, and metalloenzymes. There is a series of two hour lectures on specific topics followed by student presentations of recent research articles from the literature on said specific topics. Students are graded on their paper selection, presentation, analysis of the paper, and intellectual contribution. (Pre-requisites: PHAR 600/601)

Pharmacometric projects require mastery of new and advanced tools to conduct modeling and simulation. Students will be introduced to cloud-based software, including Pumas and R. Basic operations such as importing and restructuring data, performing summary statistical analysis and plotting will be taught. The goal, however, is not to provide the theory to interpret the data or the analysis output. The other courses in the MS Pharmacometrics program are designed to complement the tools training received in this course. This is a mandatory course to be taken in the first semester of the MS program.

Understanding pharmacokinetics (PK) and pharmacodynamics (PD) provides the pivotal basis for dosing and other related decisions during drug development and its use in clinic. This course will provide training in the fundamentals of PK and PD modeling and their application to decisions. Theoretical concepts pertaining to analyzing PKPD data, in an average subject, both from mechanistic and statistical points of view, will be taught. The course also includes hands-on training using standard modeling and simulation software. This is a mandatory course to be taken in the first semester of the MS program.

This course introduces population analysis concepts and includes hands on training. Knowledge of conducting pharmacometrics analysis is an important component of the drug development and regulatory project. However, integrating all the different pieces together is equally important. This course will guide students on how to frame the appropriate questions, engineer the analysis, interpret the results, and communicate to influence the decision-making process in drug development. This course integrates the essence of all the coursework in the program, and allows the students to appreciate the totality of a typical pharmacometrics project that is essential for decisions regarding new drug development. (Pre-requisites: PHMX 602, 663)

The field of pharmacometrics requires good understanding of statistical concepts. This course will provide the basic statistical principles required for a pharmacometrician. This introductory level course will strengthen the student's understanding of pharmacokinetic–pharmacodynamic modeling aspects. The course material is tailored for pharmacometricians. (Pre-requisite: PHMX 601)

Knowledge of designing and analyzing dose-response is an important component of a drug development or regulatory review. Basics of the variety of dose-response designs such as parallel, cross-over, flexible-dose, titration, withdrawal, adaptive and enrichment trials will be explained. Students will perform clinical trial simulations for supporting the choice of appropriate designs and analyses. Innovative designs and data analysis make characterizing dose-response feasible within the realms of drug development. The information generated from such trials is key for both approval of new drugs as well as for drug product labeling. (Pre-requisite: PHMX 601)

This course will improve students' abilities to communicate strategically and to negotiate. Students will be able to identify their communication style and will learn how to compensate for any weaknesses. Scientists in life sciences will need to work with interdisciplinary scientists with diverse backgrounds. Pharmacometrics has not reached its full potential yet and is breaking new ground. In order to influence key decisions during drug development, regulatory review or in clinics, pharmacometricians will need to communicate in a manner that is simple, persuasive, and effective. Implementation of model-based drug development calls for change from current practice, and such changes are often resisted. Scientists will need to master how to effectively negotiate amid diverse opinions to lead a team towards consensus, especially when they lack authority to implement solutions. 

Conducting population analyses and interpreting complex datasets is pivotal for several decisions, such as "go-no-go" dose selection for various patients. Theoretical concepts pertaining to analyzing PKPD data, collected from several subjects, both from mechanistic and statistical points of view, will be taught. Because data from several subjects will be analyzed simultaneously, the course will include advanced modeling techniques such as nonlinear mixed effects modeling. The course also includes hands-on training using standard modeling and simulation software. (Pre-requisites: PHMX 638, 663)

The course will provide lectures on advanced special topics by renowned experts in the field. Lectures will be provided for the following three topics: (I) Model-based meta-analysis (MBMA); (II) Target-mediated drug disposition (TMDD); and (III) NONMEM training. Students will be provided hands-on training on the above topics using real-life case studies. (Pre-requisites: PHMX 747, 759)

Understanding clinical trial data with binary, ordinal, count, and time-to-event outcomes requires specific understanding of statistical concepts. This intermediate level course will introduce application of statistical techniques like logistic regression, Poisson regression, and survival analysis. The course will also demonstrate simulation techniques associated with discontinuous outcomes. R software will be used to demonstrate the application of statistical aspects. Simulated and real data from experiments and clinical trials will be employed for practice and homework. (Pre-requisites: PHMX 638, 663)

This online course is designed to orient students of diverse professional backgrounds to several practical elements that underpin drug, biologic, and device regulation in the US and around the world. It provides the core for the curriculum and is a pre-requisite for all other courses. Elements that are explored are the legal framework for drug regulation, including events that have shaped today's framework; ethical issues in drug/biologic/device development and drug/biologic/device use; global regulatory guidance approaches; types of communications with Food and Drug Administration (FDA), including Investigational New Drug (IND) application, New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) requirements, and 510(k) clearance and Premarket Approvals / Biologics Licensing Applications (PMA/BLA) approval requirements; chemistry, manufacturing, and control (CMC) issues; and post-marketing topics.

Pharmaceutical sciences are fundamental to the discovery of new medicines and impact clinical success. This online course is designed to orient students to the basic concepts in drug chemistry and functional groups, medicinal chemistry approaches to optimizing drug action, principles of pharmacology, biological and target considerations in drug design, and how drugs are metabolized and eliminated from the body.

Well-designed clinical research is essential in the development process of a medication or device and in generation of the knowledge base for evidence-based medicine and health policy. This online course is designed to uncover the ingredients of clinical research and to orient students of several important issues with current clinical studies. The students will learn how to design and implement different clinical studies. The role of each clinical phase in drug/device development and their various study designs and regulatory issues will be explored. The course will also discuss the Principles of International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines and how to successfully manage clinical trials. Additionally, knowledge of personalized medicine and behavioral/social issues in drug use will be taught.

Drug candidates and active pharmaceutical ingredients (API) need to be successfully delivered and must exhibit acceptable toxicology. This course follows drug discovery and examines key aspects of drug development, including drug formulation and quality, stability testing, pharmacokinetic characterization, bioequivalence, preclinical toxicology, methods of bioanalysis, and non-clinical and clinical Good Laboratory Practices (GLPs). Aspects of biologics will also be discussed.

FDA approval for the marketing of the drug or other regulated product (e.g., biologics, vaccines, medical devices, laboratory tests) is a major milestone in a product's lifecycle. But it doesn't stop there. Once on the market, how a drug is used and by whom, entry of competing products into the marketplace, and changes in medical care can change the benefit-risk balance. This course covers the breadth of clinical research and surveillance activities take place in the post-approval phase of a regulated medical product's lifecycle. This includes pharmacovigilance and risk management activities, pharmacoepidemiology, pharmacoeconomics, comparative effectiveness, and drug utilization research. The course is designed to prepare students to communicate across the pre-/post-marketing divide, evaluate the need for post-marketing studies, and to be able to critically interpret and apply the results of such studies.