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

GUIDANCE DOCUMENT Q1B Photostability Testing of New Drug Substances and Products March 1996International Council on Harmonisation - Quality

The ICH Harmonised Tripartite Guideline covering the Stability Testing of New Active Substances and Medicinal Products (hereafter referred to as the Parent Guideline) notes that light testing …

Current Step 4 version Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies. 6 November 1996 Q1B

The ICH Harmonized Tripartite Guideline covering the Stability Testing of New Drug Substances and Products (hereafter referred to as the Parent Guideline) notes that light testing should be …

The International Council for Harmonisation (ICH) guideline Q1B provides a comprehensive framework for conducting photostability testing. This step-by-step guide explores the …

Mission History Transparency Funding ICH Award Work with ICH Organisational Chart Members & Observers Value of Membership Application Process Articles & Procedures Work Plans & …

This ICH guideline gives guidance on the basic testing protocol required to evaluate the light sensitivity and stability of new drugs and products.

Interpreting ICH Q1B photostability testing guidelines involves understanding the scope of testing, selecting appropriate light sources, designing a robust protocol, conducting tests, and …

Photostability testing is a critical aspect of pharmaceutical development, ensuring that drug products remain stable and effective when exposed to light. The ICH Q1B guideline provides a …