Generic Drug Product Development
International Regulatory Requirements for Bioequivalence
edited by Izzy Kanfer

Generic Drug Product Development: International Regulatory Requirements for Bioequivalence discusses worldwide legislative and regulatory requirements for the registration of generic and/or multi-source drug products.

An essential handbook for all professional involved in the regulation, development, and manufacture of brand-name or generic drugs, this guide provides expert advice on how to develop and market superior products while also successfully adhering to national and international laws.

Key topics include:

• how to choose the most appropriate reference drug product for generic and multi-source drugs
• the similarities and differences between US, European, and Asian legislative and regulatory requirements
• the importance of matching the quality and therapeutic equivalence of generic drugs manufactured domestically or imported to the brand product alternative

Contents

1. Introduction
2. Australasia
3. Brazil
4. Canada
5. The European Union
6. India
7. Japan
8. South Africa
9. South America and Pan American Health Organization
10. Taiwan
11. Turkey
12. The United States
13. The World Health Organization

Index

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