PHARMACEUTICAL SCIENCES (PHRS)

This course introduces the profession of pharmacy and the pharmaceutical sciences. An examination of the fundamental principles underlying both fields promotes an understanding that includes historical developments, issues and controversies, contemporary challenges and opportunities for innovation, and career opportunities. Importantly, students explore strategies for pharmaceutical research and care in the contexts of FDA-regulated drug development and the roles of pharmaceuticals in healthcare.

Permission must be granted by the course instructor prior to enrollment. This course is a supervised experiential research experience in a pharmaceutical sciences laboratory. Students engage in a mentored, in-depth, scholarly project wherein they frame an answerable question with a faculty course instructor, generate and interpret relevant data, and communicate their findings in written form.

Students will learn about and develop skills in topics related to the drug development pipeline (from discover, delivery, clinical pharmacology, and outcomes), pharmacy practice, and professional development. Programming consists of classroom sessions, guest speakers, panels, simulations, and site visits to hospitals, community pharmacies, and different pharmaceutical industries. Classroom sessions will be led by graduate students, post-doctoral fellows, and faculty. The classroom experience will be active learning to immerse students in scientific discourse. Restricted to learners participating in the UNC Eshelman School of Pharmacy ITPS Program.

This foundational pharmaceutical science course will provide an overview of regulatory affairs with a focus on global pharmaceutical product development. Students will learn about medical product regulation in the United States and key international markets. Students will also learn about the process for obtaining and maintaining marketing approval along with tools and approaches used by regulatory professionals. This didactic course will be taught asynchronously but will include regular touch points.

This course introduces the pharmaceutical sciences as a scientific discipline by facilitating student exploration of how new drugs are developed from the initial concept to the patient. Students gain an understanding of each stage through self-paced, asynchronous interaction with online videos highlighting the fundamental processes and rigor drug manufacturers undertake to research, develop, and deliver new medicines to patients. In class, students will engage in case-based discussions with experienced drug development professionals.

This course covers core biochemical and molecular biology techniques, concepts, and tools used to conduct research at the interface of chemistry and biology. Topics include enzymology, characterization of drug-target interactions, mechanisms-based inhibitor design, assay design and development, targeting kinases and GPCRs, biopharmaceuticals, gene therapy, nucleic-acid binding agents, information-based drugs, chemical tools to study epigenetics, harnessing biosynthetic pathways for chemical diversity, and other recent advances and techniques in drug discovery.

Organic chemistry, broadly writ (i.e., not just synthesis), underlies nearly every endeavor in medicinal chemistry (the search for new drugs) and chemical biology (the use of chemical tools to understand biology). This course provides a review of important concepts in organic chemistry as they apply to biological research. Topics include a review of intermolecular interactions as they apply to biological structures and function, a discussion of how small molecules interact with their targets.

This course will include formal instruction on evaluation research, study design, and data analyses that would be encountered in a health system pharmacy administration workplace. This course is designed to provide a broad survey of critical evaluation components, and students are encouraged to explore any topic in more depth, as needed or desired.

This course will cover the fundamentals of implementation science using examples in precision health (e.g., targeted therapies, pharmacogenomics, and tailored treatment plans). More specifically, we will discuss frameworks, strategies, study designs, and outcomes related to implementation science using examples related to the implementation of precision health in research and practice. We will apply these learnings to implementation challenges, so that future pharmacists and researchers alike can consider the application.

This data science elective course is intended to provide students with baseline knowledge of core competencies in data science and its applications across the health sciences landscape and prepares students to become successful in their profession. Pharmacists will encounter data science in different contexts throughout their careers. ASHP describes such ''informatics'' projects as including creation of clinical decision support; ensuring accuracy of medication order intent; and guiding clinicians to appropriate medication use.

Discuss basic physicochemical and transport properties of the nano drug carriers with emphasis in macromolecules, diagnosis, and therapeutics.

Students will learn the basic concept of biological barriers for drug delivery, various formulation strategies to overcome barriers, and concepts relevant to specific routes of delivery.

This course, which offered in both the Fall and Spring semesters, provides a deep look at contemporary research in Chemical Biology and Medicinal Chemistry as a pharmaceutical sciences discipline. The class format consists of seminar presentations by experts in the field, including invited outside scientists, faculty members, or doctoral candidates. Students are expected to actively engage in seminar activities and participate in impromptu discussions.

This course, which offered in both the Fall and Spring semesters, provides a deep look at contemporary research in Pharmacotherapy and Experimental Therapeutics as a pharmaceutical sciences discipline. The class format consists of seminar presentations by experts in the field, including invited outside scientists, faculty members, or doctoral candidates. Students are expected to actively engage in seminar activities and participate in impromptu discussions.

This course, which offered in both the Fall and Spring semesters, provides a deep look at contemporary research in Pharmacoengineering and Molecular Pharmaceutics as a pharmaceutical sciences discipline. The class format consists of seminar presentations by experts in the field, including invited outside scientists, faculty members, or doctoral candidates. Students are expected to actively engage in seminar activities and participate in impromptu discussions.

This course, which offered in both the Fall and Spring semesters, provides a deep look at contemporary research in Pharmaceutical Outcomes and Policy as a pharmaceutical sciences discipline. The class format consists of seminar presentations by experts in the field, including invited outside scientists, faculty members, or doctoral candidates. Students are expected to actively engage in seminar activities and participate in impromptu discussions.

This foundational pharmaceutical science course will provide an overview of the pharmaceutical product development process including challenges and issues associated with each phase. Students will learn how pharmaceutical products are identified for development and key steps in obtaining and maintaining market approval. Students will also learn about business aspects that drive the development strategy. This graduate-level didactic course will be taught asynchronously.

This foundational regulatory science course will provide an overview of regulatory affairs with a focus on global pharmaceutical product development. Students will learn about pharmaceutical product regulation in the US and other key international markets. Students will also learn about the process for obtaining and maintaining marketing approval along with tools and approaches used by regulatory professionals. This graduate-level didactic course will be taught asynchronously but will include regular touch points.

This foundational pharmaceutical science course will cover preclinical aspects of pharmaceutical product development and how they contribute to the regulatory approval process. Students will learn about the processes of drug discovery, lead optimization, and compound formulation, as well as in vitro and in vivo approaches to assess drug metabolism and pharmacokinetics, pharmacology, and toxicology. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

This foundational pharmaceutical science course will provide an overview of chemistry, manufacturing, and controls in pharmaceutical product development and how they differ by product type. Students will learn about the processes of assay development, manufacturing, and quality control for small molecules, biologics, and gene and cell therapies. Students will also learn about regulatory submissions and inspections. This graduate-level didactic course will be taught asynchronously but will include regular touch points.

This foundational pharmaceutical science course will cover clinical aspects of pharmaceutical product development and contributions to the regulatory process. Students will study the phases of clinical development and considerations for trial design, conduct, and evaluation of data. Students will also learn about bioethics and differences in clinical research in the US and key international markets. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

This foundational pharmaceutical science course will cover postmarketing aspects of pharmaceutical product development and how they contribute to maintaining regulatory approval. Students will learn about activities that help to further evaluate and exploit the full potential of a marketed pharmaceutical product including supply chain, sales and marketing, pharmacovigilance, risk management, and postmarketing research. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

This foundational pharmaceutical science course will teach basic statistical concepts used frequently during pharmaceutical product development. Students will learn the statistical terminology and approaches that are used to initiate a research investigation, plan a clinical trial, and analyze data. Students will also learn about the role of the statistician in pharmaceutical product development. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

This foundational pharmaceutical science course will provide an overview of regulatory science with focus on FDA regulatory science priorities related to innovation in pharmaceutical product development. Students will learn about current research aimed at modernizing toxicology, innovating clinical research and personalized medicine, improving manufacturing and quality, and strengthening social and behavioral science. This graduate-level didactic course will be taught asynchronously but will include regular touch points with course instructors and other students.

Designed to expose students to the broad epigenetic research interests of our large epigenetics focused faculty and expose students to a broad range of epigenetics research techniques.

This is a required course for first year pharmaceutical sciences graduate students. Students participate on cross-discipline teams to discuss topics in three foundational areas essential to their development as pharmaceutical scientists: research ethics which meets RCR training requirements; leading research articles within five areas of pharmaceutical sciences; and professional development.

Students will learn about and develop skills in topics related to pharmaceutical development and professional development. The Common Core is an interdisciplinary environment with students from each of the four Divisional PhD programs.

This advanced pharmaceutical science course will train students on strategic elements to consider when preparing for communications with regulators necessary to support and maintain pharmaceutical product marketing approval and advise on regulatory agency interactions. Students will learn how clarity and brevity should drive both presenting and summarizing of science and data considering the regulations. This graduate-level applied course will be taught synchronously and involve significant interaction with the course instructor and other students.

This advanced pharmaceutical science course will train students to integrate strategic business needs, risk assessment, and risk management when developing a regulatory plan. Using case studies and team projects, students will learn to start with the end in mind, analyze critical product life cycle events, and leverage previous experience to successfully achieve regulatory goals. This graduate-level applied course will be taught synchronously and involve significant interaction with the course instructor other students.

The goals of implementation science and precision health are to figure out ways to get the right care to the right patients at the right time. Implementation science is defined as "the study of methods to promote the translation of evidence-based practices, interventions, and policies related to precision health into practice settings to improve patient and population health." This course will cover the fundamentals of implementation science using examples in precision health.

Topic determined by instructor and announced in advance.

This course is required for all Pharmaceutical Sciences graduate students. Other students must obtain permission from the divisional course director. Class format consists of seminar presentations by students and/or faculty or invited speakers. Students are expected to actively engage in seminar activities and discussions.

Enrollment in this variable credit course requires a signed agreement between the Chair of the student's academic division and a representative of the institutional sponsor providing the research practicum. Teaching/learning methods consist of a pharmaceutical sciences-based research training experience at the participating institution involving independent work and written and oral reports.

This is a variable credit course required for all Pharmaceutical Sciences graduate students by their second semester. Teaching/learning methods consist of a pharmaceutical sciences-based mentored research training experience involving independent work and research reports that must be filed at the end of the semester.

Students register for thesis substitute credits after successfully passing their comprehensive written examinations. A minimum of 3 credit hours of thesis substitute research and writing is required for Pharmaceutical Sciences graduate students.

Students register for thesis credits after successfully passing their comprehensive written examination. A minimum of 3 credit hours of thesis research and writing is required for Pharmaceutical Sciences graduate students.

Students register for dissertation credits after successfully passing their qualifying preliminary and oral examinations. A minimum of 6 credit hours of dissertation research and writing is required for Pharmaceutical Sciences graduate students.