| Global Approach in Safety Testing: Ich Guidelines Explained 2013 Edition Contributor(s): Van Der Laan, Jan Willem (Editor), DeGeorge, Joseph J. (Editor) |
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ISBN: 1489994076 ISBN-13: 9781489994073 Publisher: Springer OUR PRICE: $161.49 Product Type: Paperback - Other Formats Published: March 2015 |
| Additional Information |
| BISAC Categories: - Medical | Pharmacy - Science | Chemistry - Organic - Medical | Research |
| Dewey: 615.190 |
| Series: Aaps Advances in the Pharmaceutical Sciences |
| Physical Information: 0.69" H x 6.14" W x 9.21" (1.01 lbs) 315 pages |
| Descriptions, Reviews, Etc. |
| Publisher Description: This volume will consider one of ICH's major categories, Safety i.e. topics relating to in vitro and in vivo pre-clinical studies (Carcinogenicity Testing, Genotoxicity Testing, etc.). Since the start of the ICH process, many guidelines have been written, but even after ICH6 no explanations have been given during a formal Congress about the background of the ICH Guidance documents. Even more important than what has been written, might have been those thoughts of the experts that are not included in the Guidance documents. Why has the guideline been written as it is written, and why have some aspects been deleted. These and other related questions are the contents of this book, written by experts who were involved in the ICH process. Furthermore, the chapters will contain discussions on the "lessons learnt" and "future developments". |