Practical considerations for effectively conducting pharmaceutical photostability testing

American Pharmaceutical Review

Volumn 10, Issue 3, 2007, Pages

  Templeton, Allen C ^a   Klein, Lee J ^a  

^a MERCK RESEARCH LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG EFFICACY; DRUG FORMULATION; DRUG MANUFACTURE; DRUG PACKAGING; DRUG SAFETY; DRUG STABILITY; LIGHT EXPOSURE; PHARMACEUTICAL CARE; PHOTOCHEMISTRY; PHOTOSENSITIZATION; QUALITATIVE ANALYSIS; QUANTITATIVE ANALYSIS; REVIEW; SIMULATION; ULTRAVIOLET RADIATION;

EID: 55749106601     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Review

References (11)

1. ICH Harmonised Tripartite Guideline, Stability Testing: Photostability Testing of New Drug Substances and Products (Q1B).
2. Containers for Dispensing Capsules and Tablets. United States Pharmacopeia and National Formulary. USP 27, NF 22. Rockville, MD: United States Pharmacopeial Convention, Inc. (2004), 2741-2746.
3. "Design Limits and Qualification Issues for Room-size Solar Simulators in a GLP Environment", P. Donald Forbes in "Drugs: Photochemistry and Photostability", A. Albini and E, Fasani, eds., The Royal Society of Chemistry, 1998.
4. "Commentary on the quinine actinometry system described in the ICH draft guideline on photostability testing of new drug substances and products", S. W. Baertschi, Eli Lilly and Company, Lilly Research Laboratories, Lilly Corporate Center, Indianapolis, IN, USA. Drug Stability (1997), 1(4), 193-195.
5. "Pharmaceutical photostability: a technical guide and practical interpretation of the ICH guideline and its application to pharmaceutical stability - part I", S. R. Thatcher, R. K. Mansfield, R. B. Miller, C. W. Davis, and S. W. Baertschi, MDS Pharma Services, Indianapolis, IN, USA. Pharmaceutical Technology North America (2001), 25(3), 98, 100, 102, 104, 106, 108, 110.
6. "Pharmaceutical photostability. A technical guide and practical interpretation of the ICH guideline and its application to pharmaceutical stability. Part II", S. R. Thatcher, R. K. Mansfield, R. B. Miller, C. W. Davis, and S. W. Baertschi, Lilly Research Laboratories, Eli Lilly, Indianapolis, IN, USA. Pharmaceutical Technology North America (2001), 25(4), 50, 52, 54, 56, 58, 60, 62.
7. Personal communications, 4th Annual "Master the Science & Strategy Behind Forced Degradation Studies", Institute for International Research, Las Vegas, NV, 2007.
8. "Unexpected Photochemistry in Pharmaceutical Products: A Review on the Role of Diluents, Excipients, and Product Components in Promoting Pharmaceutical Photochemistry", Allen C. Templeton, William E. Bowen, Lee J. Klein, Paul A. Harmon, Yu Lu, and Robert A. Reed in "Pharmaceutical Photostability and Stabilization Technology", J. T. Piechocki and K. Thoma, eds., Marcel Dekker, 2006.
9. "Implications of photostability on the manufacturing, packaging, storage, and testing of formulated pharmaceutical products", Allen C. Templeton, Hui Xu, Jiri Placek, and Robert A. Reed, Pharmaceutical Technology (2005), 29(3), 68, 70, 72, 74, 76, 78, 80, 82, 84, 86.
10. "The role of excipients and package components in the photostability of liquid formulations", Robert A. Reed, Paul Harmon, Denise Manas, Walter Wasylaschuk, Chris Galli, Ryan Biddell, Paul A. Bergquist, William Hunke, Allen C. Templeton, and Dominic Ip, PDA Journal of Pharmaceutical Science and Technology (2003), 57(5), 351-368.
11. "Practical Considerations for Effectively Conducting Pharmaceutical Photostability Testing", Allen C. Templeton, 4th Annual "Master the Science & Strategy Behind Forced Degradation Studies", Institute for International Research, Las Vegas, NV, 2007.