00000cmm a22000004i 4500 UP-99796217611094602 Buklod 20140127112436.0 m go j cr |n |||auu|a 100922s2011 nyu u eng d 9781441974495 (eBook) 1441974490 (eBook) (iLib)UPD-00212403850 DLC DML eng DMLUC RS 189 G33 2011eb Gad, Shayne C. 1948- Safety evaluation of pharmaceuticals and medical devices [electronic resource] international regulatory guidelines Shayne C. Gad. New York Springer c2011. 1 online resource (xi, 126 p.) ill. (some col.) Preface -- Introduction to Safety Assessment in Drug and Medical Device Development -- Drugs: The General Case -- Ind Enabling Toxicology Programs -- Nonclinical Safety Evaluation Studies Conducted To Support Continued Clinical Development -- Supporting Marketing Applications -- Special Therapeutic Category And Route Of Administration Cases -- Device Safety Evaluation -- Appendix A -- Index. IP-based subscription, access limited to within on-campus computer network. Access via Electronic Resources of the UPD University Library Website. 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. Electronic reproduction. New York SpringerLink 2011. Available via World Wide Web through Springerlink. Drugs Standards. Medical instruments and apparatus Safety regulations. Electronic books. SpringerLink (Online service). Available for University of the Philippines Diliman via SpringerLink. Click here to access http://link.springer.com/book/10.1007/978-1-4419-7449-5 (viewed 19 May 2014) FO Monograph UPD DMLR Electronic Resource