Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines / Edition 1

Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines / Edition 1

by Shayne C. Gad
     
 

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

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Overview

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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Product Details

ISBN-13:
9781441974488
Publisher:
Springer US
Publication date:
11/01/2010
Edition description:
2011
Pages:
126
Product dimensions:
6.10(w) x 9.10(h) x 0.50(d)

Table of Contents

Preface
1. Introduction to Safety Assessment in Drug and Medical Device Development
2. Drugs: The General Case
3. Ind Enabling Toxicology Programs
4. Nonclinical Safety Evaluation Studies Conducted To Support Continued Clinical Development
5. Supporting Marketing Applications
6. Special Therapeutic Category And Route Of Administration Cases
7. Device Safety Evaluation
Appendix A
INDEX

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