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PHARBE 500 Molecular and Cellular Biology for Pharmaceutical Bioengineering I (4)
Case based examination of fundamental molecular processes that occur in organisms. Topics include structure and organization of prokaryotic and eukaryotic cells, prokaryotic and eukaryotic gene structure and regulation, signaling pathways, RNA, DNA, metagenomics, and systems biology. Integrates online literature/media resources and bioinformatics. Cultivates critical thinking approaches to latest developments. Offered: A.

PHARBE 502 Pharmaceutics I (4)
Covers the drug development process for both small molecules and biological form discovery stage through the end of phase 1. Addresses the science, logistics, and regulatory environment of preclinical (pharmacology, PKDM, toxicology, CMC) and early clinical development. Offered: Sp.

PHARBE 503 Pharmaceutics II (5)
Covers phases II and III of the drug development process. Topics include clinical study design, safety, pharmacology, and statistics. Provides an overview of the preparation and filing of the New Drug Application (NDA). Uses case studies to demonstrate key concepts. Prerequisite: PHARBE 502 or permission of instructor. Offered: S.

PHARBE 505 Pathophysiology for Pharmaceutical Bioengineering (4)
Introduction to human anatomy, physiology, molecular biology and cell biology of major organ systems. Emphasis on the structural, molecular, and cellular mechanisms of common pathological conditions (pathophysiology). Additional emphasis on pharmaceutics development for common pathologic states. Students will understand the basics of normal and aberrant human physiology. Offered: W.

PHARBE 506 Pharmaceutical Bioengineering Seminar (2)
Provides a deeper understanding of the biotech and pharmaceutical industries through a mix of scientific talks, presentations by industry leaders, and discussions with program alumni. Students also practice professional skills, such as resume and cover letter writing and interviewing skills. Credit/no-credit only. Offered: A.

PHARBE 510 Applied Pharmacokinetics (5)
Covers basic principle of pharmacokinetics and its impact on treatment, including: single-dose intravenous and oral kinetics, multiple dosing, nonlinear pharmacokinetics, metabolite kinetics, pharmacogenetics, the role of disease in drug clearance and dose requirements, and kinetics of drug-drug interactions. Offered: A.

PHARBE 511 Process Development (5)
Examines the principles involved in designed and developing production processes for protein therapeutics. Covers technologies, methods, and unit operations used in the development and GMP manufacture of biopharmaceuticals. Includes interdependencies of upstream, downstream, analytical, formulation and drug delivery technologies, illustrated with key biochemical, chemical, and physical chemical reaction examples. Offered: W.

PHARBE 513 Clinical Development (6)
Evaluates clinical development strategies including comprehensive drug candidate life cycle plan. Covers clinical trial design, FDA and Institutional Review Boards, ethics, consents, safety, and quality. Discusses target product profiles, phase III study synopses, informed consents, and SWOT analyses. Students present phase II results and debate go no go decisions. Offered: Sp.

PHARBE 521 Drug Discovery and Design (5)
Explores general principles and current approaches involved in modern drug discovery and development. Includes specific aspects of human biology and disease, case studies in discovery, and the evolution of how these topics have merged. Covers novel drug discovery techniques, emerging non-standard therapeutics, and the history of drugs and drug discovery. Offered: A.

PHARBE 522 Molecular Targets and Drug Classes (5)
Discusses select medicinal compounds, emphasizing mechanism of action, biotransformation, and structural and physical properties governing absorption, distribution, and excretion. Design of therapeutics to focus on maximizing efficacy while reducing toxicities. Compounds include classical organic small-molecules, peptides, proteins, nucleic acids, lipids, carbohydrates, and other bioactive chemical classes. Offered: W.