Pharmacokinetics in Drug Development Volume 2 details the key regulatory and development paradigms in which pharmacokinetic supplements decision-making during drug development.

Contents

Part 1: Drug Development and Regulatory Issues

1. Drug Development: A Rational Approach
2. Experimental Design Considerations in Pharmacokinetic Studies
3. Exposure-Response Relationships: A Critical Review of the FDA Guidance and Its Practical Utility
4. Role fo Toxicology and Toxicokinetics in Drug Development
5. Bioanaysis in a Regulated Environment
6. Role of Preclinical Pharmacokinetics in Drug Development
7. Pharmacokinetics/Pharmacodynamic Knowledge Discovery and Creation During Drug Development
8. Regulatory Aspects of Clinical Pharmacokinetic Studies
9. Regulatory Review of Pharmacokinetic Studies
10. Regulatory Perspectives on Clinical Trial Simulations
11. Nuances of Drug Metabolism and Pharmacokinetic Requirements for Package Submission to Japanese Regulatory Authorities

Part 2: Special Topics

1. Drug Development in Oncology
2. Development of Chiral Compounds
3. Development of Controlled-release Products
4. Development Considerations for Biological Drugs
5. Pharmacokinetics is Ocular Drug Development
6. Development of Parenteral Dosage Forms
7. Development of Transdermal Products

Index

Also available:
Volume 1: Clinical Study Design and Analysis

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