Q1B: Photostability Testing of New Drug Substances and Products

Regulatory Resource: Q1B: Photostability Testing of New Drug Substances and Products

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in November 1996. This forms an annex to the main stability guideline, and give guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

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