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studies or short duration dose ranging studies that define a maximum tolerated dose in the general toxicity test species (Refs. 6 and 7). Other equally appropriate studies include those that achieve large exposure multiples (e.g. 50-fold the clinical C max or AUC at the intended

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Guideline on good pharmacovigilance practices …

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Guideline for good clinical practice E6(R2)

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Guideline on good pharmacovigilance practices …

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harmful physical or psychological effects [DIR 2001/83/EC Art 1(1 6)]. 74 Adverse event (AE); synonym: Adverse experience 75 Any untoward medical occurrence in a patient or clinical- trial subject administered a medicinal product

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European Medicines Agency

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products1/traditional herbal medicinal products

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