New Drug Development: A Regulatory Overview (Revised Fifth Edition)

Mark Mathieu; Ronald Keeney; Christopher-Paul Milne

ISBN 10: 1882615557 / ISBN 13: 9781882615551

Published by Parexel International, USA, 2000

About this Item

1882615557. Softcover, from closed pharmaceutical company library. Lending record shows this book has never been borrowed. 492 pages, index. Addresses cutting-edge developments, redefining how new drugs are developed and regulated Contents clean, tight and bright.

Seller Inventory # 028322

Bibliographic Details

• Title: New Drug Development: A Regulatory Overview (Revised Fifth Edition)
• Publisher: Parexel International, USA
• Publication Date: 2000
• Language: English
• ISBN 10: 1882615557
• ISBN 13: 9781882615551
• Binding: Soft cover
• Edition: 5th or later Edition
• Condition: Near Fine
• Book Type: Book
• Seller catalogs:
  • Pharmaceutical Industry

About this title

Synopsis

Go inside the drug development and FDA regulatory process with today's most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today,* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.* How the CDER's efforts to integrate a culture of drug safety has affected the center's structure and its new drug review and approval processes.* How CDER's much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDA's drug submission and review process.* How the FDA and industry are already integrating pharmacogenomics, computer simulation, and other emerging technologies to inform key decisions.* Which drug development strategies are fulfilling their promise and offering optimal returns for industry, given the explosion of accelerated development/approval programs and pilot programs to speed the drug development and review process.Find out why New Drug Development is pharma/biotech's go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDA's drug development approval processes.