| International Pharmaceutical Product Registration Contributor(s): Cartwright, Anthony C. (Editor), Matthews, Brian R. (Editor) |
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ISBN: 1420081764 ISBN-13: 9781420081763 Publisher: CRC Press OUR PRICE: $277.20 Product Type: Hardcover Published: August 2009 Annotation: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan. |
| Additional Information |
| BISAC Categories: - Medical | Pharmacology - Medical | Pharmacy |
| Dewey: 615.19 |
| LCCN: 2009015392 |
| Series: Drugs and the Pharmaceutical Sciences |
| Physical Information: 1.8" H x 6.9" W x 10.1" (3.40 lbs) 852 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: Discover the latest ICH news from international experts in the pharmaceutical industry, academia, and regulatory bodies. The recent International Conference on Harmonisation (ICH) revisions of regulatory requirements for quality, nonclinical, and clinical pharmaceutical product registration are the focus of this timely update. This cutting-edge resource includes the major headings in the modular structure of the Common Technical Document (CTD), which is now the agreed format for product information submission. The format, specification, and technical requirements of the e-CTD, the electronic version of CTD, are also thoroughly discussed. The book is organized into six highly practical segments:
This text is a must-have for those in the pharmaceutical industry determining regulatory requirements for the major world markets in Europe, the US, Canada, and Japan. |