ICH guidelines "General Considerations for Clinical Studies" released

ICH (International Council For Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use) recently released the final version of the ICH E8(R1). This is the first time they specifically mention "Modelling and simulations" as a source of evidence in an official guideline.

You can find the full ICH harmonised guideline "General Considerations for clinical studies" E8(R1) here.



Date: 20/10/2021 | Tag: | News: 1233 of 1251
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