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The top documents tagged [new drug approval process]
Pharmaceutical Process Scale-Up
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Pharmaceutical Process Scale-Up, Second Edition
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Oral Lipid Based Formulations Enhancing the Bioavailability of Poorly Water-Soluble Drugs
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Toxicology in Drug Development Lynnda Reid, Ph.D. Pharmacology/Toxicology Reviewer Center for Drug Evaluation and Research (CDER) Rafael Ponce, Ph.D.,
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Regulatory Issues. Introduction to the Regulatory Approval Process; Overview of the FDA Investigational New Drug Application (IND); Summary of regulations
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