The ICH Plans To Propose Q14 Guideline On Analytical Testing In January
The ICH is expected to release for public comment early next year its draft Q14 guideline establishing a lifecycle approach for analytical testing, as well as a Q2(R2) guideline to add some newer analytical methods.
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EU industry group advises drug makers on how to prepare for enhanced quality-by-design approaches to analytical methods that the International Conference on Harmonization plans to propose early next year. ICH recently shared its concept, which involves revising its Q2(R2) guideline and adding a Q14 guideline, and its business plan for establishing the guidance.
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