AI Article Synopsis
- A public workshop took place in Japan to discuss the ICH E17 guideline aimed at improving how pharmaceuticals are tested and understood across different populations.
- Key topics included examining the intrinsic and extrinsic ethnic factors affecting treatment results and the importance of a comprehensive assessment of treatment consistency.
- The workshop emphasized the need for open communication about these evaluations among regulatory authorities, sponsors, and other stakeholders to enhance the guideline's implementation.
Article Abstract
To further our understanding of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E17 guideline and promote effective implementation, a public workshop was held in Japan by regulatory agency and industry representatives. In this workshop, important concepts explained in the ICH E17 guideline, such as intrinsic/extrinsic ethnic factors that influence treatment effects ("effect modifiers") and the holistic evaluation of consistency of treatment effect were actively discussed through case studies. The importance of holistic evaluation of consistency was recognized, and it was concluded that the evaluation and relevant discussion should be shared with regulatory authorities, sponsors, and broader stakeholders.
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| http://dx.doi.org/10.1002/cpt.3163 | DOI Listing |
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