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Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule?

Paper ID Volume ID Publish Year Pages File Format Full-Text
29827 44442 2009 6 PDF Available
Title
Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule?
Abstract

Photosafety assessments are recommended for all new drug candidates intended for clinical use. In 2002, Testing guidances were issued by the regulatory authorities in the USA (2003) and Europe (2002). A key requirement is to measure the absorption of UV–visible light by a compound in the 290–700 nm range and to assess photostability. Further photosafety evaluation is recommended for molecules which absorb light energy in this region and may be unstable in light. Consequently, the current guidances do not specify what constitutes a significant level of light absorbance or photoinstability. The current study was undertaken to determine the level of light absorption by measuring the molar extinction coefficients (MEC) of a wide range of compounds reported in the literature to have known photosafety issues in humans. The results have shown that all compounds tested have absorbance intensities significantly above an MEC threshold of 1000 L mol−1 cm−1 and also display a wide range of photoinstability. The measurement of light absorption is a contributing part of an overall pre-clinical photosafety risk assessment process, whereas photostability assessments have proven to have limited value. Molecules with an MEC less than 1000 L mol−1 cm−1are deemed less of a photosafety risk since this low level of light absorption is unlikely to prove harmful.

Keywords
Photosafety; Photostability; Molar extinction coefficient
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Can light absorption and photostability data be used to assess the photosafety risks in patients for a new drug molecule?
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Publisher
Database: Elsevier - ScienceDirect
Journal: Journal of Photochemistry and Photobiology B: Biology - Volume 96, Issue 1, 17 July 2009, Pages 57–62
Authors
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Subjects
Physical Sciences and Engineering Chemical Engineering Bioengineering
Get Full-Text Now
Don't Miss Today's Special Offer
Price was $35.95
You save - $31
Price after discount Only $4.95
100% Money Back Guarantee
Full-text PDF Download
Online Support
Any Questions? feel free to contact us