Bioavailability and
Bioquiovalence: Objectives, bioavailability & variations, measurements
of bioavailability, enhancing bioavailability, concepts of equivalents,
official bioequivalence protocols & therapeutic equivalence.
Drug Absorption: General
consideration, absorption / drug transport mechanisms, role factors
affecting absorption, absorption of drug non-peroral routes, methods of
determining absorption-in-vitro, in-situ, and in-vivo
methods.
Drug Distribution: Factors
affecting, protein & tissue binding, kinetics, determination of rate
constants & different plots (direct, Scatchard, & reciprocal).
Pharmacokinetcs: Parameters
& determination, pharmacokinetic models – one compartment, multi
compartment in IV bolus, IV infusion & extra vascular, drug &
metabolites levels in blood, urine and other
biological fluids. Integration of kinetics.
Application of pharmacokinetics
in new drug development, design of dosage forms and novel drug delivery
systems.
Drug Disposition and
Excretion: Biotransformation,
factors affecting biotrasformation,
Phase I & Phase-II reactions.
Clearance: Concept,
renal, non-renal clearance, mechanism, determination, % drug metabolized,
different volume of distribution.
Pharmacokinetics of Multiple
Dosing: Various terminology, determination, adjustment of
dosage in renal & hepatic impairment, individualization of therapy,
therapeutic drug monitoring.
Non-linear kinetics: Cause of
non-linearity, estimation of various parameters, bioavailability of drugs that
follow non-linear kinetics. Chronopharmacokinetics & pharmacokinetics of
elderly and infants.