ICH Q1B Photostability testing of new active substances and medicinal products - Scientific guideline

HumanScientific guidelines

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This document provides guidance on photostability information to be submitted in the application for marketing authorisation for new active substances and associated medicinal products.

Keywords: Photostability, light, stability, active substance, finished product, quinine actinometry

Current effective version

ICH: Q 1 B: Photostability testing of new active substances and medicinal products - Step 5

Adopted Reference Number: CPMP/ICH/279/95 Legal effective date:

English (EN) (150.26 KB - PDF)

Julkaistu ensimmäisen kerran: Viimeksi päivitetty:
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