New Drug Development : Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics
Book Details
Format
Hardback or Cased Book
Book Series
Drugs and the Pharmaceutical Sciences
ISBN-10
0824754654
ISBN-13
9780824754655
Publisher
Taylor & Francis Inc
Imprint
CRC Press Inc
Country of Manufacture
US
Country of Publication
GB
Publication Date
May 24th, 2004
Print length
602 Pages
Weight
953 grams
Product Classification:
Biology, life sciencesPharmaceutical technology
Ksh 34,200.00
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Highlighting key points from the latest regulatory requirements, this book helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost and attain guidance through each step of the drug approval process.
Highlighting key points from the latest regulatory requirements, New Drug Development helps those new to the world of pharmaceutical development understand regulatory steps, reduce cost by avoiding unnecessary trials, and attain guidance through each step of the drug approval process. This volume acquaints readers with procedures that determine the success of drug development projects with updated regulatory guidelines from the FDA and ICH, solutions to hurdles in application protocols, and recommendations from more than 40 respected and experience officials from regulatory agencies around the globe. It covers topics related to the development of chiral drugs, liposomal products, and more.
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