This course presents the basic concepts and principles of biopharmaceutics and pharmacokinetics. The necessary mathematical expressions needed to characterize the absorption, distribution, metabolism, and excretion of drugs will be discussed with respect to routes of administration. Parameters that influence pharmacokinetic and therapeutic outcomes of the most common drug regimens will be emphasized. In addition, this course highlights some recent models i.e. compartmental models, their mathematical backbone and their relation to logical conclusions of drug time course in the body.
COURSE LEARNING OUTCOMES (CLO)
CLO: 1. To describe the mechanism, methodologies and mathematical approaches involved in drug elimination, protein binding and IV infusions.
CLO: 2. To illustrate pharmacokinetic variations in various disease states, biopharmaceutical considerations in product development and various approaches used in bioavailability and bioequivalence studies
CLO: 3. To apply knowledge of biopharmaceutics and pharmacokinetics in in-vitro in-vivo correlation (IVIVC), product development and clinical settings.
- ELIMINATION OF DRUGS:
- Hepatic Elimination: Percent of Drug Metabolized, Drug Biotransformation reactions, (Phase-I reactions and phase-II reactions), First pass effect, Hepatic clearance of protein bound drugs and Biliary excretion of drugs.
- Renal Excretion of Drugs: Renal clearance, Tubular Secretion and Tubular Reabsorption
- Elimination of Drugs through other organs: Pulmonary excretion, salivary excretion, Mammillary excretion, Skin excretion and Genital excretion.
- PROTEIN BINDING:
- Introduction, types, kinetics, determination and clinical significance of drug-protein binding.
- PHARMACOKINETICS VARIATIONS IN DISEASE STATES:
- Determination of pharmacokinetics variations in renal and hepatic diseases, general approaches for dose adjustment in renal disease and hepatic diseases.
- PHARMACOKINETICS OF INTRAVENOUS INFUSIONS:
- BIOPHARMACEUTICAL ASPECTS IN DEVELOPING A DOSAGE FORM:
- Drug considerations, drug product considerations, patient considerations, manufacturing considerations, pharmacodynamic considerations pharmacokinetic considerations.
- BIOAVAILABILITY AND BIOEQUIVALENCE:
- Introduction. Bioavailability types, parameters, significance and study protocol Methods of Assessment of Bioavailability. Bioequivalence study designs, components and application, report format.
- IN-VITRO-IN-VIVO CORRELATION (IVIVC):
- Introduction, levels and determination of in-vitro/in-vivo correlation.