Rodney J.Y. Ho
Covers basic principles of biopharmaceutics drug delivery, and therapeutic response and their application to traditional and biotherapeutics, including oral and non-oral route of drug administration. Includes fundamental principles related to assessment of bioavailability and bioequivalence, drug-drug, and food-drug interactions and genetic basis for oral or parenteral drugs. Prerequisite: PCEUT 532. Offered: Sp.
Basic principles of biopharmaceutics and drug delivery, and their application to therapeutics, including oral and non-oral routes of drug administration for traditional and biotechnology drugs. Fundamental principles related to assessment of bioavailability and bioequivalence, drug-drug, and food-drug interactions for orally administered drugs.
The goals of this course are to provide students with (1) an understanding of the fundamental biopharmaceutics concepts which transform proteins and chemical compounds into safe and effective drugs for use in humans; (2) skills in application of biopharmaceutics in formulating and optimizing the dosage forms and regimens for small molecule as well as protein drugs.
Student learning goals
1. To define the basic biopharmaceutic principles and the role of drug delivery in translating a compound/protein into drugs
2. To differentiate between small molecular weight compounds and protein drugs with respect to (a) pharmacokinetic and disposition characteristics; pharmacodynamics or effects (b) bioavailability and bioequivalence as they relate to generic drug formulations and biosimilar protein products
3. To define groups of proteins with similar molecular functions that may span across several therapeutic indications
4. To learn how physiologic, environmental, and genetic variations, as well as formulation and route of administration may modulate drug delivery ; to understand how genetic determinants of individual patients may play a role in variations in pharmacokinetics and overall therapeutic response.
5. To delineate how drug delivery strategies may impact therapeutic index and overall safety and efficacy of drug therapies; how advanced drug delivery systems are being developed or implemented to optimize efficacy, safety, and patient compliance.
6. To learn about gene and cell therapeutics some of which are now approved for human use; to discuss animal cloning and stem cell research as they relate to potential human therapeutic products; and to discuss new vaccine designs, adjuvant use, and vaccine delivery systems which are in development to improve safety and efficacy.
General method of instruction
Lectures, notes, and reading assignments
Read assignments, text and other materials ahead of specific lecture topics.
Students are expect to learn and be able to integrate the concepts into practical applications
Class assignments and grading
Students are expected to read the assigned materials ahead of the lecture topics.
This course will have two midterms and a final exam.
Each midterm exam will count 30% of the final grade. The final (40%) will be divided between newly covered material (60-70% of the exam) and a comprehensive portion. The final exam will consist of two portions, the first will be over the material covered since the last exam (considered midterm exam III) and the second is comprehensive (considered the comprehensive final).
The course total is converted by a 4-point scale by a regression line with 4.0 = 95 points and 2.5 = 75 points. Scores below 50 will receive 0-point.