Pharmaceutical Product Development: In Vitro-In Vivo Correlation 1st Edition

During the last two decades, the pharmaceutical industry has been under pressure to reduce development costs and the time needed to bring drugs to market in order to maximize return on investment and bring treatments to patients sooner. To meet these ends, pharmaceutical scientists working in the differing areas of pharmacy, pharmaceutics, and pharmacokinetics are collaborating to address physicochemical and biological issues in the early stages of development to avoid problems in later stages. In Vitro-In Vivo Correlation (IVIVC) is a multidisciplinary tool that has been successfully applied in testing the effectiveness of a drug substance. The only comprehensive guide available on IVIVC, this source 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.

Table of Contents

Introduction. Dissolution: Fundamentals of In Vitro Drug Release and Biopharmaceutics Classification System (BCS). Pharmacokinetics: Basics of Drug Absorption from a Biopharmaceutical Perspective. IVIVC Models: Development and Validation. Computational Approaches to Develop IVIVC Models. IVIVC - Pharmaceutical Drug/Product Development. Role of IVIVC in the Early Phases of Drug Discovery and Drug Delivery Technology Development. IVIVC - Setting Dissolution Specifications. IVIVC - Oral Drug Delivery: Immediate Release and Extended Release Dosage Forms. In Vitro-In Vivo Correlation for Modified Release Parenteral Drug Delivery Systems. IVIVC - Transdermal and Other Novel/Special Drug Delivery Systems. Regulatory Perspective. Regulatory Guidance on IVIVC: Across the World