Fourth Professional, First Semester, Pharmaceutics

PHARMACEUTICS-X (Biopharmaceutics-I)
(Theory)

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1 DEFINITIONS AND TERMINOLOGY: Biopharmaceutics, Generic Equivalence, Bioavailability, Bioequivalence, Drug Disposition, Therapeutics, Pharmacokinetics, Biotransformation and Therapeutic Equivalents.

2. GASTRO-INTESTINAL ABSORPTION AND PHYSICO-CHEMICAL CONSIDERATIONS. Forces which help in transmembrane movements, pH Partition Theory, Lipid Solubility and Factors affecting Bioavailability.

3. BIOAVAILABILITY STUDIES: Purpose, Relative and Absolute Bioavailability, and Determination of Bioavailability.

4. FACTORS AFFECTING DISSOLUTION IN RESPECT OF BIOAVAILABILITY: Methods of in-vitro and in-vivo determination of rate of dissolution.

5. MULTIPLE DOSAGE REGEMIN.

6. INTRAVENOUS INFUSIONS.

7. BIOPHARMACEUTICAL AND PHARMACOKINETIC ASPECTS IN DEVELOPING A DOSAGE FORM.
PHARMACEUTICS-X (Biopharmaceutics)
(Laboratory)

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NOTE:- Practicals 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.

Recommended Books

1. Leon Shargel, Applied Pharmacokinetics and Biopharmaceutics, Appleton & Lange, New York, 4th Ed., 1999.
2. Malcoln Rouland, Thomous N Tozer, Clinical Pharmacokinetics, William & Willkins, London, 1995.
3. Milo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics, Marchel & Dakker Inc, New York, 1982.
4. Gibbson and Skett, Introduction to Drug Metabolism, Champ & Hall,London, 1986.
5. Robert E Notari, Biopharmaceutics and Clinical Pharmacokinetics, Marchel & Dakker Inc, New York, 1988.
6. Stephen H Curry, Drug disposition and pharmacokinetics, Black Well Scientific Publishing, Oxford, 1977.
7. Avraham Yacobi, Toxicokinetics and New Drug Development, Paramount Press, New York, 1989.
8. Sarfraz Niazi, Text Book of Biopharmaceutics and Clinical Pharmacokinetics. Appleton-Century-Crofts, New York, 1985.
9. P Macheras, C Reppas and J B Dressman, Biopharmaceutics of orally administered drugs, Ellis Horwood Limited, London (1995).
10. Albert P Li, Invitro approaches for evaluation of drug efficacy and toxicity, CRC Press LLC, USA, 2004.
11. Ronald D Schoenwald, Pharmacokinetics in drug discovery and Development, CRC Press, LLC, USA, 2002.