New drug approvel process : Accelerating global registrations
By: Guarino, Richord A
.
Series: Drugs and the Pharmaceutical Sciences. Swarbrick, James.Publisher: New York 2008Edition: 4th.Description: 635, 23.4*15.6 | Binding- Hard Bound |.ISBN: 0-8247-5041-1.Subject(s): PHARMACEUTICSDDC classification: 615 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.
| Item type | Current location | Collection | Call number | Vol info | Status | Date due | Barcode | Item holds |
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Text Books
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School of Pharmacy Special Reference (RR) | Reference | 615 GUA (Browse shelf) | Vol. 139 | Not For Loan | B0825 |
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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