Abstract
The extent of non-clinical safety testing to support clinical trials at different stages of development differed greatly between the EU, Japan and the USA prior to the adoption of the original ICH M3 guidance in 1997. The guideline achieved some notable harmonizations, but there was still significant disharmony, especially around the duration of dosing for non-rodents and the timing and extent of reproductive toxicology studies to support trials in women of childbearing potential. The inability to harmonise on these particular issues led to a reluctant acceptance of finalising the M3 guidance.
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