BO4201 Pharmacokinetics and Pharmacodynamics Syllabus:
BO4201 Pharmacokinetics and Pharmacodynamics Syllabus – Anna University PG Syllabus Regulation 2021
OBJECTIVES
This subject will enable the students
to understand the essential principles of pharmacokinetics and pharmacodynamics required for the development of formulations.
To understand the basic concepts in biopharmaceutics and pharmacokinetics.
To derive the pharmacokinetic models and parameters to describe the process of drug absorption, distribution, metabolism and elimination.
To critically evaluate biopharmaceutic studies involving drug product equivalency.
To understand the factors affecting bioavailability of drugs.
UNIT I FUNDAMENTALS ON DRUG ABSORPTION AND DISTRIBUTION
Definitions, various routes of administration with advantages/disadvantages, bioavailability concepts in drug absorption and distribution, theories of drug dissolution, drug partition hypothesis, permeability and distribution of drugs, perfusion rate and volume of distribution, protein binding of drugs, kinetics of drug binding, various factors that affect drug absorption and distribution, drug interactions in the level of drug absorption and distribution.
UNIT II FUNDAMENTALS ON DRUG METABOLISM AND EXCRETION
Biotransformation of drugs, pathways and enzymes of drug metabolism, Phase I and Phase II, drugs excretion –renal and non-renal routes, various factors that affect drug metabolism and excretion, prodrugs, drug interactions in the level of drug metabolism and excretion, bioavailability concepts in drug metabolism and excretion.
UNIT III PHARMACOKINETIC INVESTIGATION AND EVALUATION
Concept of therapeutic concentration, time-profile, rates and various order of reactions (first, zero, mixed), Michaelis- Menton kinetics, differential equations for a simple pharmacokinetic models, compartment models (one, two, multi, open models), definition and calculation of parameters such as drug half-life, of Drugs, Volume of Distribution, and bioavailability(AUC) and their application to compartment models and kinetics of IV Bolus administration, comparison between bioavailability and bioequivalence.
UNIT IV PHARMACODYNAMIC FUNDAMENTALS
Definitions – agonist/antagonist, antagonism as a mechanism of drug action, classification of antagonists, drug-receptor interactions, factors affecting drug-target interactions, law of mass action applied to drugs, quantifying drug-target interactions: dose-response relationships – graded dose and quantal dose-responses; molecular mechanisms mediating drug action, receptor coupling and transduction mechanisms, intracellular transduction mechanisms, second messenger systems, amplification of drug responses, factors modifying drug responses.
UNIT V APPLICATION OF PK/PD PRINCIPLES IN DOSAGE FORM DEVELOPMENT
Regimens for dosage form design, concentration response relationships, individualization therapeutics, controlled release formulations and novel drug delivery (oral, parenteral, transdermal, ophthalmic and intrauterine) systems, bioavailability testing of novel release formulations.
TOTAL : 45 PERIODS
COURSE OUTCOME
CO1. Explain the various factors influencing the drug disposition, various pharmacokinetic parameters
CO2. Design and interpret the bioavailability and bioequivalence of dosage forms.
CO3. Identify the factors affecting the rate of drug absorption.
CO4. Know about clinical pharmacokinetics
CO5. Recognize the application of pharmacokinetics
CO6. Be familiar with applications of Biopharmaceutics.
REFERENCES
1. Brahmankar, D.M., “Biopharmaceutical and Pharmacokinetics: A Treatise”, Vallabh Prakashan, 1995.
2. Notari, R.E., “Biopharmaceutics and Clinical Pharmacokinetics: An Introduction”, 4thedition, Marcell Deckker, 2005
3. Oliver Kayser, Rainer H. Müller, “Pharmaceutical Biotechnology: Drug Discovery and Clinical Applications”, Wiley-VCH Publication, Jan 2004
4. Schoenwald, R.D., “Pharmacokinetics In Drug Discovery And Development”, CRC Press, 2002.