New drug approvel process : Accelerating global registrations

By:

Guarino, Richord A

Language: ENG Series: Drugs and the Pharmaceutical Sciences | Swarbrick, JamesPublication details: New York 2008Edition: 4thDescription: 635, 23.4*15.6 | Binding- Hard Bound |ISBN:

0-8247-5041-1

Subject(s):

PHARMACEUTICS

DDC classification:

615 GUA DDC23

Online resources:

Click here to access online

Summary: Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.

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Holdings
Item type	Current library	Collection	Call number	Vol info	Status	Barcode
Books	School of Pharmacy Special Reference (RR)	Reference	615 GUA (Browse shelf(Opens below))	Vol. 139	Not For Loan	B0825

Total holds: 0

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Offering expert guidance on the clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals, and medical devices, the Fourth Edition details the specific regulations, guidelines, and procedures that will advance and ensure approval of United States and global new product applications. It communicates and integrates a new approach to the world of pharmaceutical personnel on all aspects of new product development and alerts readers to clinical and regulatory tasks that require immediate attention and long-term follow-up in order to comply with the international acceptance of new product approvals.

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