International scientific guideline: Strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

About this guideline

Overseas effective date: 1 February 2018

Categories: Clinical efficacy and safety | Clinical pharmacology and pharmacokinetics | Product-specific bioequivalence

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For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.