1. Definitions and terminology: Biopharmaceutics, Generic Equivalence, Bioavailability, Bioequivalence, Drug Disposition, Therapeutics, Pharmacokinetics; ladmer (Liberation, absorption, distribution, Metabolism, elimination and Response) System; and Therapeutic Equivalents.
2. Gastro-intestinal absorption: Forces which help in transmembrane movements, Anatomical and physiological factors influencing absorption of drugs. Physicochemical properties of drugs affecting absorption. Absorption of different oral dosage forms.
3. Biological halflife and volume of distribution: Introduction, types, methods of determination and application
4. Drug clearance: introduction, mechanism, models, determination and relationship of clearance with half-life.
5. Pharmacokinetics: Introduction, Linear and Non-linear Pharmacokinetics Application of pharmacokinetics in clinical situations.
6. Bioavailability and bioequivalence
b. Bioavailability types, parameters, significance and study protocol.
c. Methods of Assessment of Bioavailability
d. Bioequivalence study designs, components and application, report format
7.Concept of compartment(s) models:
I. One compartment open model.
a. Intravenous Injection (Bolus) b. Intravenous infusion.
II. Multicompartment models.
a. Two compartment open model.
b. IV bolus, IV infusion and oral administration
III. Non-compartmental Model.
Statistical Moment Theory; MRT for various compartment models; Physiological Pharmacokinetic model.
8. Multiple dosage regimen
a. Introduction, principles of superposition
b. Factors: persistent, accumulation and loss factors
c. Repetitive intravenous injections – one compartment open model
d. Repetitive Extravascular dosing – One Compartment Open model
e. Multiple dose regimen – two compartment open model
9. Elimination of drugs:
a) 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.
b) Renal Excretion of Drugs: Renal clearance, Tubular Secretion and Tubular Reabsorption.
c) Elimination of drugs through other organs: Pulmonary excretion, Salivary excretion, mammilary excretion, skin excretion and genital excretion.
10. Protein binding: Introduction, types, kinetics, determination and clinical significance of
drug- protein binding.
11. 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.
12. Pharmacokinetics of intravenous infusions.
13. Biopharmaceutical aspects in developing a dosage form drug considerations, drug product considerations, patient considerations, manufacturing considerations, pharmacodynamic considerations pharmacokinetic considerations
14. In-vitro-in-vivo correlation (ivivc): Introduction, levels and determination of in-vitro/in-vivo correlation