ENGLISH

Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines

By Shayne C. Gad (auth.)

Book information

Publisher
Springer US
Year
2011
ISBN
1441974482, 9781441974488, 1441974490, 9781441974495
DOI
10.1007/978-1-4419-7449-5
Language
english
Format
PDF
Filesize
2 MB (2572243 bytes)
Edition
1
Pages
126\139
Time added
2011-06-04 13:46:07
Pharmacology/Toxicology; Pharmaceutical Sciences/T

Description

Safety Evaluation of Pharmaceuticals and Medical Devices has been written to provide complete, ready and clear guidance as to what nonclinical safety assessment tests need to be performed to move a regulated therapeutic medical product into and through the development process and to marketing approval. This intent is purposely extended to cover the closely related product types of vaccines, biotechnology products, gene therapy, cell therapy, and combination products into a single, concise guide for the process in all the major world market countries. The approach of this volume is to first address the broadest scope “general case” for the regulatory nonclinical safety evaluation by ICH and ISO adhering countries, then to branch out to cover the differences in requirements associated with specific therapeutic areas (such as oncology), major routes of administration (with oral being the general case, other routes starting with parentheral, dermal and inhalation are addressed). Large molecules biotechnology products are then considered, followed by special courses of product marketing approval, and finally the remaining national differences.

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