1996年1月7日 · This document covers the generation and submission of stability data for well-characterised proteins and polypeptides, their derivatives and products of which they are …

ICH Q5C intends to give guidance to applicants regarding the type of stability studies to be provided in support of marketing authorisation applications for biological medicinal products. …

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 guidance stated in the ICH harmonised tripartite guideline “Stability Testing of New Drug Substances and Products” (27 October 1993) applies in general to biotechnological/biological …

The guidance stated in the ICH Harmonised Tripartite Guideline ‘Stability Testing of New Drug Substances and Products’ (27 October 1993) applies in general to biotechnological/biological …

ICH Guidelines. All Guidelines; Quality Guidelines; Safety Guidelines; Efficacy Guidelines; Multidisciplinary Guidelines; Index of Guidelines; ICH Standards. MedDRA; CTD; Electronic …

Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the …

The ICH Q1 series (Q1A-Q1E) as a Tier 1 guideline, ICH Q5C, and the WHO stability guidance covering Climatic Zones III and IV (i.e., content of the withdrawn ICH Q1F) are implemented …

The ICH Q5C guidelines provide detailed instructions on conducting stability studies for biotechnological and biological products. This guide offers a step-by-step approach to …

2014年3月1日 · This guideline forms an annex to the main ICH Stability Guideline (Q1A) and deals with the particular aspects of stability test procedures needed to take account of the …