A practical, hands-on guide for successfully developing oral drug products, this comprehensive reference runs the gamut from theoretical stages of computer-based calculations to practical guidelines for establishing in vitro/in vivo correlations.

Its coverage details the interrelationship between the physiology of the gastrointestinal tract and oral drug formulations and absorption, and progresses to the latest applications of pharmacokinetic analysis. Includes chapters by the innovators of the Biopharmaceutical Classification Scheme (BCS), human perfusions, and biorelevant dissolution testing!

With over 600 literature references, equations, drawings, and photographs, Oral Drug Absorption:

• offers multiple methods for predicting permeability, solubility, and dissolution for oral bioavailability and bioequivalence
• facilitates selection of appropriate drug candidates for development
• fully elaborates on the experimental and data analysis techniques of in vitro/in vivo correlations
• provides guidance to the Federal Drug Administration’s BCS and its applications
• appends helpful case studies to the concepts discussed
• and much more!

Oral Drug Absorption is an invaluable tool and useful reference in the hands of pharmaceutical scientists, medicinal chemists, pharmacists, pharmacologists, toxicologists, biochemists, gastroenterologists, regulatory personnel, and graduate school students in these disciplines.

Contents

1. Gastrointestinal Variables
   1. Gastrointestinal Transit and Drug Absorption
   2. Permeability in the Gastrointestinal Tract
   3. Gastrointestinal Disease and Dosage Form Performance

2. Membrane Permeability
   4. Intestinal Permeability: Prediction from Theory
   5. In Vitro Methods for the Assessment of Permeability
   6. Animal Perfusion Studies
   7. Human Perfusion Studies
   8. The Role of Permeability Studies in Preclinical Evaluation

3. Solubility and Drug Dissolution
   9. Solubility as a Limiting Factor to Drug Absorption
   10. Dissolution Testing of Immediate-Release Products and Its Application to Forecasting In Vivo Performance
   11. Dissolution Tests for Extended-Release Products
   12. Dissolution Testing in the Development of Oral Drug Products
   13. Analysis of Drug Dissolution Data

4. In Vivo–In Vitro Correlations
   14. Convolution and Deconvolution Methods
   15. The Correlation of In Vitro and In Vivo Drug Dissolution
   16. IVIVC: A Perspective from the Workbench

Index

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