UNIT II Bioavailability and bioequuivalence definitions significance factors – – – – involved Assessment bioequivalence testing legal consideration – – – – Dissolution rate Methods, Apparatus, significance. – UNIT III Drug disposition Distribution Localisation of drugs Metabolism and – – – – elimination of drugs Renal clearance Factors, Kinetics. – – UNIT IV Pharmacokinetics; Introduction-Basic concepts Rate processes in – – biological systems pharmacokinetic parameters-biological – volume of distribution, clearance, absorption rate constant – Methods of determination significance and applications. – UNIT V Compartment models basic concepts one and two compartment models – – – Kinetics of blood levels pharmacokinetics of absorption, distribution, – – metabolism and elimination under the following conditions; i) intravenous bolus injection. ii) Intravenous infusion .iii) oral single dose – and iv) oral multiple dose. – TEXT BOOKS Biopharmaceutics and Pharmacokinetics An Introduction by Robert E. Notari, 2nd – edn. 1975, Marcel Dekkar Inc., New York. The theory and practice of Industrial Pharmacy By leon Lachman, 2nd edn, 1985 and 3rd edn. 1987, Warghese publishing Bombay. REFERENCE BOOKS Remingtons Pharmaceutical sciences 17th edn. 1985 Mac Publishing Co., Easton, Pennsylvania. Modern Pharmaceutics by Banker, 1979, Marcel Dekker Inc., New York.
UNIT – II Bioavailability and bioequuivalence – definitions – significance – factors involved – Assessment – bioequivalence testing – legal consideration – Dissolution rate – Methods, Apparatus, significance. UNIT – III Drug disposition – Distribution – Localisation of drugs – Metabolism and elimination of drugs – Renal clearance – Factors, Kinetics. UNIT – IV Pharmacokinetics; Introduction-Basic concepts – Rate processes in biological systems – pharmacokinetic parameters-biological volume of distribution, clearance, absorption rate constant – Methods of determination – significance and applications. UNIT – V Compartment models – basic concepts – one and two compartment models – Kinetics of blood levels – pharmacokinetics of absorption, distribution, metabolism and elimination under the following conditions; i) intravenous bolus injection. ii) Intravenous infusion .iii) oral – single dose and iv) oral – multiple dose. TEXT BOOKS Biopharmaceutics and Pharmacokinetics – An Introduction by Robert E. Notari, 2nd edn. 1975, Marcel Dekkar Inc., New York. The theory and practice of Industrial Pharmacy By leon Lachman, 2nd edn, 1985 and 3rd edn. 1987, Warghese publishing Bombay. REFERENCE BOOKS Remingtons Pharmaceutical sciences 17th edn. 1985 Mac Publishing Co., Easton, Pennsylvania. Modern Pharmaceutics by Banker, 1979, Marcel Dekker Inc., New York.
bpholdsyllabus.docx