New Drug Development: A Regulatory Overview (NEW DRUG

Condition - Very Good
The item shows wear from consistent use, but it remains in good condition and functions properly. Item may arrive with damaged packaging or be repackaged. It may be marked, have identifying markings on it, or have minor cosmetic damage. It may also be missing some parts/accessories or bundled items.

New Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU))
- Used Book in Good Condition
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 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 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.

Country	USA
Binding	Hardcover
Brand	Brand: Parexel International Corporation
EAN	9781882615728
Edition	7
Feature	Used Book in Good Condition
ISBN	1882615727
Label	Parexel International Corporation
Manufacturer	Parexel International Corporation
NumberOfPages	389
PublicationDate	2005-05
Publisher	Parexel International Corporation
Studio	Parexel International Corporation
ReleaseDate	0000-00-00

New Drug Development: A Regulatory Overview (NEW DRUG DEVELOPMENT ( MATHIEU))

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