ICH Q6A and Q6B should be consulted for recommendations on the setting and justification of acceptance criteria, and ICH Q1D should be referenced for recommendations on the use of full- versus reduced-design studies.

This document explains how to use stability data generated in accordance with the ICH guideline Q1A (R2) to propose a retest period or shelf life in a registration application. It covers stability studies using single- or multi-factor designs and full or reduced designs.

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 Stability Guideline Series Q1A-F and Q5C by:

This guidance provides recommendations on how to use stability data generated in accordance with the principles detailed in the ICH guidance Q1A (R2) Stability Testing of New Drug Substances and...

Q1E provides recommendations on : How to use stability data generated according to Q1AR When and how a retest period or a shelf life can be extended beyond the period covered by long-term data Q1E contains examples of statistical approaches to stability data analysis

ICH Q1E, titled “Evaluation of Stability Data,” provides a. systematic approach to analyzing stability testing results. It offers statistical tools and methodologies to assess trends in stability data, enabling manufacturers to make informed decisions about shelf life and storage conditions.

2013年11月4日 · • Key Q1E notes: – Application of significant change, generation of ICH intermediate condition data (when needed), and utilization of all 3 batches’ stability data

Q1E: Evaluation of Stability Data START COURSE This training material is part of a larger set of trainings for ICH-Q1, thus we recommend you review the Q1A, Q1B, Q1C, and Q1D materials before proceeding.

2025年3月9日 · ICH Q6A and Q6B should be consulted for recommendations on the setting and justification of acceptance criteria, and ICH Q1D should be referenced for recommendations on the use of full- versus reduced-design studies. Principles. The design and execution of formal stability studies should follow the principles outlined in the parent guideline.

Begin by thoroughly reviewing the ICH Q1E guidelines, which outline the principles for evaluating stability data, including statistical methods for analyzing trends and criteria for determining shelf life.