Biopharmaceutics & PK-I – 7th Semester

The 7th semester of the Pharm-D program lays a strong foundation in both basic and pharmaceutical sciences, integrating theoretical and practical knowledge essential for future clinical practice.

Theory Subjects:

Course Learning Outcomes:
1. Introduction and fundamentals of Biopharmaceutics and Pharmacokinetics: Biopharmaceutics, biopharmaceutics classification system (BCS), Pharmacokinetics, drug disposition, bioavailability and bioequivalence.
2. Drug Absorption: Drug absorption mechanisms, Physicochemical, physiological and formulation factors affecting drug bioavailability. Absorption of different oral dosage forms.
3. Biopharmaceutics of Topical, Transdermal, inhalation and injectable formulations
4. Biopharmaceutics assessment using in vitro, in silico, in situ and ex vivo tools
5. Bioavailability and Bioequivalence: Introduction, Bioavailability types, parameters, significance and study protocol, Methods of Assessment of Bioavailability, Bioequivalence study designs, components and application, Biowaivers.
6. Drug Metabolism and Elimination: Drug Metabolism, Drug Elimination, Drug Biotransformation reactions, (Phase-I reactions and phase-II reactions), First pass effect.
7. Drug Excretion and Clearance: Renal excretion, Tubular Secretion and Tubular Reabsorption. Pulmonary excretion, Biliary excretion, salivary excretion, Mammilary excretion, Skin excretion and Genital excretion. Drug clearance and factors affecting drug
clearance.
8. Protein Binding: Introduction, types, kinetics, determination and clinical significance of drug-protein binding.
9. Biopharmaceutical Aspects in Developing a Dosage Form: Role of biopharmaceutics in developing a new dosage form. Biopharmaceutical evaluation of dosage forms. Biopharmaceutics classification system (BCS). Introduction to invitro in vivo (IVIVC) correlation studies.