Saf Eval Int Reg for Dru and Med

"Safety Evaluation: International Regulations for Drug and Medical Device Approval" analyzes the international drug laws and regulations that pertain to safety and prescribes how safety procedures can be implemented.

This book describes the development process for products in various markets, outlining those aspects of drug and device regulation related to evaluating safety.

It presents a review of the major regulatory bodies responsible for approval of new products, particularly in the US, EU, and Japan, and provides a clear understanding of the regulation requirements.

Additional coverage includes current synthesis of disparate regulations, a lexicon of acronyms, and a Web site directory.