New Drug Development: A Regulatory Overview Mark Mathieu

ISBN: 9780988314405

Published:

Hardcover

362 pages


Description

New Drug Development: A Regulatory Overview  by  Mark Mathieu

New Drug Development: A Regulatory Overview by Mark Mathieu
| Hardcover | PDF, EPUB, FB2, DjVu, audiobook, mp3, RTF | 362 pages | ISBN: 9780988314405 | 10.80 Mb

Go inside the drug development and FDA regulatory process with todays most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developmentsMoreGo inside the drug development and FDA regulatory process with todays most authoritative and popular reference on the topic. In its all-new 2008 edition, New Drug Development: A Regulatory Overview addresses the most cutting-edge developments redefining how new drugs are developed and regulated today, including:* How the FDA Amendments Act of 2007 will affect everything from drug reviews to postmarketing requirements.* How the CDERs efforts to integrate a culture of drug safety has affected the centers structure and its new drug review and approval processes.* How CDERs much-anticipated January 2008 transition to the eCTD as the only valid esubmission format will affect the FDAs 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/biotechs go-to resource for regulatory, clinical, project management, training, and other drug development disciplines navigating the FDAs drug development approval processes.



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