New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) Hardcover – January 1, 2008
Author: Mark Mathieu | Language: English | ISBN: 1882615859 | Format: PDF, EPUB
New Drug Development: A Regulatory Overview ) – January 1, 2008
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Review
This book provides the most comprehensive and up-to-date analysis of FDA's new drug development process available today. I recommend this well-written book for professionals engaged in the drug development and review process. --Biopharm Magazine
This book is superb! It is the single best source of information on the drug regulatory system. --Peter Barton Hutt, Covington & Burling
This book is superb! It is the single best source of information on the drug regulatory system. --Peter Barton Hutt, Covington & Burling
Download latest books on mediafire and other links compilation New Drug Development: A Regulatory Overview (New Drug Development ( Mathieu)) Hardcover – January 1, 2008
- Series: NEW DRUG DEVELOPMENT ( MATHIEU)
- Hardcover: 362 pages
- Publisher: Parexel Intl Corp; 8 Revised edition (January 1, 2008)
- Language: English
- ISBN-10: 1882615859
- ISBN-13: 978-1882615858
- Product Dimensions: 1.1 x 8.5 x 10.8 inches
- Shipping Weight: 2.6 pounds (View shipping rates and policies)
- Amazon Best Sellers Rank: #391,964 in Books (See Top 100 in Books)
- #29 in Books > Science & Math > Chemistry > Clinical
Biologics Development: A Regulatory Overview, by Mark Mathieu is a 330 page book, containing 15 chapters. The paper is a off-white. There are about ten tables and flow charts, and reproductions of two forms, FDA Form 356h and the MedWatch form. This is a review of the second edition (but the currently available edition is still very short, around 350 pages).
Overall, the book is a walk-through that takes us along various rules in Title 21 of the CFR. The book is useful, in that it teaches a pharma or biotech employee things that management might not have time to teach. This book fills a niche, in that other books on clinical trials generally fail to disclose back and forth communications between the sponsor and FDA. But for the price charged for this book, the book does not go far enough. It is only an overview or introduction.
We learn that CBER has an office called OCTMA that provides guidance on how to go about filing an IND. We learn that the IND must be submitted using Form 1571, and that INDs include the Investigator's Brochure and Clinical Study Protocol (pages 64-66) to be used in the Phase I study, and that the CSP must be accompanied with the Consent Form. We learn that Institutional Review Board (IRB) approval is not needed for submitting an IND, but IRB approval is required before carrying out the actual study.
We learn that the Chemistry, Manufacturing, and Control Data (CMC) part of the IND includes drug substance, drug product, placebo (page 67), labels, and environmental analysis requirements sections, and that the Pharmacology & Toxicology Data section includes animal studies, in vitro studies, previous human experience, studies.
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