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 ...
Recent regulatory guidance has encouraged a lifecycle approach to pharmaceutical product development. One of the advantages of such an approach, including a Quality by Design (QbD) framework for ...
ICH Q14 Draft Guideline: Analytical Procedure Development In March 2022, the ICH Q14 draft guideline was published for public consultation aiming to describe science- and risk-based approaches for ...
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