The International Council for Harmonization (ICH) has issued ICH E9 (R1) training materials meant to improve the planning, design, analysis and interpretation of clinical trials by defining suitable ...
ROCKVILLE, MD – The International Council for Harmonisation (ICH) is expected to adopt its M13A guideline on bioequivalence (BE) testing of immediate-release (IR) solid oral dosage form drugs this ...
The flexibility and incompatibility of ICH Q12 guidelines with current EU legislations raise complications. As the world’s economy is increasingly threatened by new barriers to trade, the ...
The final ICH E6 (R3) Good Clinical Practice (GCP) Guidelines were published on 6 th January 2025, updating the framework for clinical trials to reflect modern trial designs, technology, and data ...
The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...
ICH will be taking industry comments under consideration when it revises its Q9 guideline in order to clarify QRM requirements, says Susan J. Schniepp, executive vice-president of post-approval pharma ...
Good Clinical Practice (GCP), the bedrock of ethical and high-quality clinical research, guides operations among sponsor companies, contract research organisations (CROs), investigator sites, and ...
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