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New drug approval process

Author: Richard A Guarino
Publisher: New York : Informa Healthcare, ©2009.
Series: Drugs and the pharmaceutical sciences, v. 190.
Edition/Format:   eBook : Document : English : 5th edView all editions and formats
Summary:
The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.
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Genre/Form: Electronic books
Additional Physical Format: Print version:
New drug approval process.
New York : Informa Healthcare, ©2009
(DLC) 2009007532
(OCoLC)311059894
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Richard A Guarino
ISBN: 9781420088502 1420088505
OCLC Number: 466868975
Description: 1 online resource (xviii, 529 pages) : illustrations.
Contents: Front Cover; Preface; Contents; PART I ADMINISTRATIVE GUIDELINES FOR NEW PRODUCT DEVELOPMENT; 1. Drug Development Teams; 2. FDA Approvable Indications and Other Considerations; 3. Data Presentation for Global Submissions: Text and Tabular Exposition --
CTD Format; 4. Technology Change --
Enabling Clinical Research and Drug Development Processes; 5. Working with a Contract Research Organization (CRO); 6 Industry and FDA Liaison; PART II GLOBAL REGULATORY SUBMISSION OF DRUGS, BIOLOGICS AND DEVICES FOR NEW PRODUCT APPROVAL; 7. Nonclinical Drug Development: Pharmacology, DrugMetabolism, and Toxicology.
Series Title: Drugs and the pharmaceutical sciences, v. 190.
Responsibility: edited by Richard A. Guarino.

Abstract:

The thoroughly revised Fifth Edition of New Drug Approval Process supplies readers with the latest global changes that affect pharmaceutical product approval and influence how new products are researched and marketed.

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