Biopharmaceutics and Pharmacokinetics
Drug absorption, distribution, metabolism and excretion (ADME); pharmacokinetic parameters and models; bioavailability and bioequivalence.
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Course contents — unit by unit · PCI NEP 2020 BP602T
Unit 1 · Introduction to Biopharmaceutics and Pharmacokinetic Parameters 10 hrs
An introduction to biopharmaceutics and pharmacokinetics; and the pharmacokinetic parameters derived from the plasma drug-concentration versus time curve, together with the pharmacodynamic parameters that relate exposure to drug response.
Unit 2 · Drug Absorption 10 hrs
The mechanisms of drug absorption through the gastrointestinal tract; and the physicochemical, physiological, pharmaceutical and patient-related factors that influence the rate and extent of absorption.
Unit 3 · Distribution and Elimination 10 hrs
Drug distribution — tissue permeability, protein binding of drugs and the apparent volume of distribution; and elimination — drug metabolism and its basic pathways, together with renal and non-renal excretion and their kinetics.
Unit 4 · Bioavailability and Bioequivalence 9 hrs
The definition and objectives of bioavailability and bioequivalence studies; the protocols for their assessment; and in vitro–in vivo correlation and its regulatory significance.
Unit 5 · Pharmacokinetic Modelling 6 hrs
Compartment modelling — one- and two-compartment open models for intravenous and extravascular administration; multiple-dosage regimens and dosage adjustment; and non-linear pharmacokinetics.
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