U.S. Food and Drug Administration, Silver Spring, MD. Illustrates emerging importance of in vitro-in vivo correlation (IVIVC) in the drug development process. Topics include fundamentals of in vitro release and the biopharmaceutics classification system, and more. For researchers. DNLM: Drug Design.
Preface
p. v
Contributors
p. ix
Dissolution: Fundamentals of In Vitro Release and the Biopharmaceutics Classification System
p. 1
Pharmacokinetics: Basics of Drug Absorption from a Biopharmaceutical Perspective
p. 29
Approaches to Developing In Vitro-In Vivo Correlation Models
p. 47
The Role of In Vitro-In Vivo Correlation in Product Development and Life Cycle Management
p. 71
In Vitro-In Vivo Correlation
p. 107
IVIVC for Oral Drug Delivery: Immediate Release and Extended Release Dosage Forms
p. 125
In Vitro-In Vivo Correlation for Modified Release Parenteral Drug Delivery Systems
p. 141
In Vitro-In Vivo Correlation: Transdermal Drug Delivery Systems
p. 153
In Vitro-In Vivo Correlation: A Regulatory Perspective with Case Studies
p. 177
Index
p. 197
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