The objective of this ICH GCP Guideline is to provide a unified standard to facilitate the mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory …
Harmonisation for better health | ICH
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) brings together regulatory authorities and the pharmaceutical industry to discuss the …
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process.
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Q3B(R2) - ICH
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 5 February 2003, this guideline is recommended for adoption to the three regulatory parties to ICH
ICH Official web site : ICH
*This list provides the official names of the Members and Observers used by the ICH Association. Only these names shall be used in ICH when referring to these entities. In addition, national, and other …
The Template should be used in conjunction with other ICH guidelines relevant to the conduct of clinical trials.
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Q1A(R2) - ICH
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 application …
The core Draft Guideline focuses on assessing product stability using the concepts established within the ICH Q1 series and ICH Q5C. Alternative approaches may be applied to any part of the guideline, …
ICH M10: “For fixed dose combination products and specifically labeled drug regimens, the freeze-thaw, bench top, and long-term stability tests of an analyte in matrix should be conducted with the matrix …
VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY ICH Harmonised Tripartite Guideline Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 6 November …