Drug Elimination, Bioavailability & Bioequivalence Notes [U-2]
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Elimination
- Drug Metabolism (Biotransformation)
- Renal Excretion of Drugs
- Factors Affecting Renal Excretion of Drugs
- Renal Clearance (Clᵣ)
- Non renal routes of drug excretion of drug
Bioavailability and Bioequivalence
- Bioavailability (BA): Definition and Objectives
- Absolute and Relative Bioavailability
- Measurement of Bioavailability
- In-vitro drug dissolution models
- In-Vitro-In-Vivo Correlation (IVIVC)
- Bioequivalence Studies
- Methods to Enhance the Dissolution Rates and Bioavailability of Poorly Soluble Drugs
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Biopharmaceutics and Pharmacokinetics
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Unit-I: Drug Elimination, Bioavailability, and Bioequivalence Notes Summary
This section covers key aspects of drug elimination and the principles of bioavailability and bioequivalence.
1. Drug Elimination
- Metabolism: Focuses on the biotransformation of drugs, primarily in the liver, through Phase I (oxidation, reduction, hydrolysis) and Phase II (conjugation) metabolic pathways.
- Renal Excretion: Involves filtration, secretion, and reabsorption in the kidneys.
- Factors Affecting Renal Excretion: Includes age, renal function, drug properties, and plasma protein binding.
- Renal Clearance: A quantitative measure of the efficiency of renal drug elimination.
- Non-Renal Excretion: Includes pulmonary, biliary, salivary, and sweat excretion routes.
2. Bioavailability and Bioequivalence
- Definitions and Objectives: Bioavailability refers to the rate and extent of drug absorption. Bioequivalence ensures therapeutic equivalence between drug products.
- Types: Absolute (comparison to IV route) and relative (comparison between oral formulations).
- Measurement Techniques: Include plasma drug concentration profiles and urinary excretion data.
- In-vitro Models and IVIVC: Drug dissolution testing and in-vitro-in-vivo correlations predict absorption.
- Enhancement Strategies: Use of solubilizers, particle size reduction, and formulation techniques to improve dissolution and bioavailability of poorly soluble drugs.
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