1. Historical Overview of the Development of Genotoxic Impurities Guidelines and their Impact

  1. Andrew Teasdale
  1. Ron Ogilvie1 and
  2. Andrew Teasdale2

Published Online: 3 JAN 2011

DOI: 10.1002/9780470929377.ch1

Genotoxic Impurities

Genotoxic Impurities

How to Cite

Ogilvie, R. and Teasdale, A. (2011) Historical Overview of the Development of Genotoxic Impurities Guidelines and their Impact, in Genotoxic Impurities (ed A. Teasdale), John Wiley & Sons, Inc., Hoboken, NJ, USA. doi: 10.1002/9780470929377.ch1

Editor Information

  1. AstraZeneca, Leicester, United Kingdom

Author Information

  1. 1

    Pfizer, Kent, United Kingdom

  2. 2

    AstraZeneca, Leicester, United Kingdom

Publication History

  1. Published Online: 3 JAN 2011
  2. Published Print: 14 FEB 2011

ISBN Information

Print ISBN: 9780470499191

Online ISBN: 9780470929377

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Keywords:

  • genotoxic impurities guidelines' development - and threshold of toxicological concern concept, genotoxic impurities guidelines and their impact;
  • concepts and principles, outlined in finalized guideline - real significance in achieving a useful guidance;
  • SWP Q & A document, investigational medicinal products - of appropriate quality with respect to potential GIs

Summary

This chapter contains sections titled:

  • Introduction

  • CPMP — Position Paper on the Limits of GIs—2002

  • Guideline on the Limits OF GIs—DRAFT, June 2004

  • Phrma (Mueller) White Paper

  • Finalized Guideline on the Limits of GIs—June 2006

  • Issues Associated with Implementation

  • SWP Q&A Document

  • FDA Draft Guideline

  • Other Relevant Guidance

  • Conclusions

  • References