ICH Q8

iSpeak Blog

Phase III Clinical Trials - Ever Wonder Why Some Products Unexpectedly Fail?

7 August 2019

A fundamental flaw in the way the industry develops manufacturing processes could be the reason.

Guidance Docs

GMP Regulation Handbook: Pharmaceutical Development, ICH Q8(R2)

1 November 2009

Guidance for Industry, Pharmaceutical Development Q8(R2) U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug...