The only comprehensive guide available on In Vitro-In Vivo Correlation (IVIVC), Pharmaceutical Product Development: In Vitro-In Vivo Correlation illustrates the emerging importance of IVIVC in the drug development process, and covers the most recent advances and regulatory perspectives on the role of IVIVC in the pharmaceutical industry.

Including contributions from leading product development experts, this guide:

• presents the theory and successful application of IVIVC
• includes mathematical algorithms for model development and validation
• discusses the role of IVIVC in the early phases of drug discovery and special drug delivery systems
• provides regulatory guidance on the usage of IVIVC worldwide

Contents

1. Dissolution: Fundamentals of In Vitro Drug Release and Biopharmaceutics Classification System (BCS)
2. Pharmacokinetics: Basics of Drug Absorption from a Biopharmaceutical Perspective
3. Approaches to Develop In Vitro-In Vivo Correlation Models
4. The Role of In Vitro-In Vivo Correlation in Product Development and Life Cycle Management
5. In Vitro-In Vivo Correlation
6. In Vitro-In Vivo Correlation for Oral Drug Delivery: Immediate Release and Extended Release Dosage Forms
7. In Vitro-In Vivo Correlation for Modified Release Parenteral Drug Delivery Systems
8. In Vitro-In Vivo Correlation: Transdermal Drug Delivery Systems
9. In Vitro-In Vivo Correlation: Regulatory Perspective with Case Studies

Index

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