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
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.
Note
Practical of the subject shall be designed from time to time on the basis of the above mentioned theoretical topics and availability of the facilities e.g. Blood Sampling Techniques (In laboratory animals like dog, rabbits, mice etc. in human beings), In-vitro dissolution studies, Optional dose determination, Measurement of rate of Bioavailability, Determination of relative and absolute bioavailability. Plasma level-time curve (Determination of Pharmacokinetic parameters). Determination of plasma protein binding. Urinary sampling techniques in laboratory animals. Renal excretion of drugs or drug disposition in animals and humans