8. Regulatory Applications

  1. Rick Ng PhD, MBA

Published Online: 30 APR 2008

DOI: 10.1002/9780470403587.ch8

Drugs: From Discovery to Approval, Second Edition

Drugs: From Discovery to Approval, Second Edition

How to Cite

Ng, R. (2008) Regulatory Applications, in Drugs: From Discovery to Approval, Second Edition, John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470403587.ch8

Author Information

  1. A-Bio Pharma Pte Ltd, Singapore

Publication History

  1. Published Online: 30 APR 2008
  2. Published Print: 7 NOV 2008

ISBN Information

Print ISBN: 9780470195109

Online ISBN: 9780470403587

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Keywords:

  • good laboratory practice (GLP) and good manufacturing practice (GMP);
  • regulatory applications;
  • drug approval process

Summary

This chapter contains sections titled:

  • Introduction

  • Food and Drug Administration

  • European Union

  • Japan

  • China

  • India

  • Australia

  • Canada

  • Case Study #8

  • Summary of Important Points

  • Review Questions

  • Brief Answers and Explanations

  • Further Reading