Commentary

A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision

  1. Steven W. Baertschi1,*,
  2. Karen M. Alsante2,
  3. Hanne H. Tønnesen3

Article first published online: 4 FEB 2010

DOI: 10.1002/jps.22076

Issue

Journal of Pharmaceutical Sciences

Journal of Pharmaceutical Sciences

Volume 99, Issue 7, pages 2934–2940, July 2010

Total views since August 2010: 454

Additional Information

How to Cite

Baertschi, S. W., Alsante, K. M. and Tønnesen, H. H. (2010), A critical assessment of the ICH guideline on photostability testing of new drug substances and products (Q1B): Recommendation for revision. J. Pharm. Sci., 99: 2934–2940. doi: 10.1002/jps.22076

Author Information

  1. 1

    Eli Lilly and Company, Analytical Sciences Research and Development, Lilly Research Laboratories, Indianapolis, Indiana 46285

  2. 2

    Pfizer Global Research & Development, Analytical Research & Development, Eastern Point Rd., Box 4077, Groton, Connecticut 06340

  3. 3

    Department of Pharmaceutics, School of Pharmacy, University of Oslo, PO Box 1068, Blindern, 0316 Oslo, Norway

*Eli Lilly and Company, Analytical Sciences Research and Development, Lilly Research Laboratories, Indianapolis, Indiana 46285. Telephone: 317-276-1388; Fax: 317-277-2154.

Publication History

  1. Issue published online: 23 APR 2010
  2. Article first published online: 4 FEB 2010
  3. Manuscript Accepted: 4 DEC 2009
  4. Manuscript Received: 20 NOV 2009

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