Shayne C. Gad Safety Evaluation of Pharmaceuticals and Medical Devices - Оценка безопасности лекарственных средств и изделий медицинского назначения

Inteational Regulatory Guidelines
Springler, 2011, XII, 128 p. 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. 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 Notable Regulatory Inteet Addresses