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Biopharmaceutics & Pharmacokinetics: Pharmaceutics-VA (Biopharmaceutics & Pharmacokinetics)

Course Outline

1. Multiple Dosage Regimens

a. Introduction, principles of superposition

b. Factors: persistent, accumulation and loss factors

c. Repetitive Intravenous injections – one compartment open model

d. Repetitive Extravascular dosing – One compartment open model

e. Multiple dose regimen – two compartment open model

2. Elimination of Drugs:

a) Hepatic Elimination. Percent of drug metabolized, drug biotransformation reactions, (phase-i reactions and phase-ii reactions), first pass effect, hepatic clearance of protein bound drugs and biliary excretion of drugs.

b) Renal excretion of drugs: renal clearance, tubular secretion and tubular reabsorption.

c) Elimination of Drugs through other organs: Pulmonary excretion, salivary excretion, mammillary excretion, skin excretion and genital excretion.

3. Protein binding: Introduction, types, kinetics, determination and clinical significance of drug-protein binding.

4. Pharmacokinetics Variations in Disease States. Determination of pharmacokinetics variations in renal and hepatic diseases, general approaches for dose adjustment in renal disease and hepatic diseases.

5. Pharmacokinetics of intravenous infusions.

6. Biopharmaceutical aspects in developing a dosage form drug considerations, drug product considerations, patient considerations, manufacturing considerations, pharmacodynamic considerations pharmacokinetic considerations

7. In-vitro-in-vivo correlation (ivivc): Introduction, levels and determination of in-vitro/in-vivo correlation

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