AI Article Synopsis
- The ICH guideline on photostability, established in 1996, offers a framework for testing the stability of new drugs during manufacturing, storage, and distribution, but it does not address how drugs perform under actual patient use conditions.
- The pharmaceutical industry has gained substantial experience with photostability studies following this guideline, yet several issues have emerged that suggest the need for revisions.
- This commentary aims to outline key issues for the ICH revision process, explain how these might affect testing protocols and results, and suggest clarifications to improve the guideline.
Article Abstract
The ICH guideline on photostability (ICH Topic Q1B) was published in November 1996 and has been implemented in all three regions (US, EU, and Japan). The guideline describes a useful basic protocol for testing of new drug substances and associated drug products for manufacturing, storage, and distribution, but it does not cover the photostability of drugs under conditions of patient use. The pharmaceutical industry now has considerable experience in designing and carrying out photostability studies within the context of this guideline, and issues have been identified that would benefit from the revision process. The purpose of this commentary is to accomplish the following: (i) highlight issues proposed for consideration in the ICH revision process, (ii) offer a rationale for why these issues may compromise the design of a testing protocol and/or the results of the testing program, and (iii) provide recommendations for clarification of the guideline.
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| http://dx.doi.org/10.1002/jps.22076 | DOI Listing |
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