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- W1418592435 abstract "Introduction to Drug Development and Regulatory Decision-Making Larry Lesko Evolution of Drug Development and its Regulatory Process Hank Malinowski Regulatory Bases for Clinical Pharmacology and Biopharmaceutics Information in a New Drug Application Mehul Mehta New Drug Application Content and Review Process for Clinical Pharmacology and Biopharmaceutics Chandra Sahajwalla In-Vitro Drug Metabolism Studies During Development of New Drugs Shiew-Mei Huang Drug Transporters Xiaoxiong Wei Principles, Issues, and Applications of Interspecies Scaling Iftekhar Mahmood Analytical Method Validation Brian Booth Studies of the Basic Pharmacokinetic Properties of a Drug: A Regulatory Perspective Maria Sunzel Surrogate Markers in Drug Development Jurgen Venitz Population Pharmacokinetic and Pharmacodynamic Analysis Jogarao V. S. Gobburu Scientific and Regulatory Considerations for Studies in Special Population Chandra Sahajwalla Conducting Clinical Pharmacology Studies in Pregnant and Lactating Women Kathleen Uhl" @default.
- W1418592435 created "2016-06-24" @default.
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- W1418592435 date "2004-05-24" @default.
- W1418592435 modified "2023-09-27" @default.
- W1418592435 title "New Drug Development: Regulatory Paradigms for Clinical Pharmacology And Biopharmaceutics" @default.
- W1418592435 hasPublicationYear "2004" @default.
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