The following guideline is a revised version of the ICH Q1A guideline and defines the stability data package for a new drug substance or drug product that is sufficient for a registration …

This document defines the stability data package for a new drug substance or drug product that is sufficient for a registration application within the ICH regions. It does not cover the information …

Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH …

The purpose of this revision is to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance Q1F...

The purpose of this revision is to harmonize the intermediate storage condition for zones I and II with the long-term condition for zones III and IV recommended in the ICH guidance Q1F...

Purpose of stability studies is to establish a re-test period applicable to all further batches of the drug substance manufactured under similar circumstances. It is based on results of physical, …

CPMP/ICH/380/95 1/13 STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS ICH Harmonised Tripartite Guideline [EMEA Status as of December 1993] Preamble The …

ICH Q1A(R2) categorizes stability testing into three primary types: Long-Term Testing: Conducted under recommended storage conditions to evaluate shelf life. Accelerated Testing: Performed …

2021年10月23日 · Q1A (R2) - Stability Testing of New Drug Substances and Products: This guidance is for analysis of the product for its stability in different environmental conditions.

Accelerated testing under ICH Q1A(R2) serves several key objectives: Predict Shelf Life: Estimate the product’s stability over its intended shelf life. Identify Degradation Pathways: Analyze …