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Podcast : FDA Guidance for Industry Psychedelic Drugs Extensively studied for potential therapeutic efficacy, psychedelic drug development comes with its own set of clinical development requirements. Read or listen now.
FDA’s clinicalpharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. First, Cathy Gelotte, a clinicalpharmacology consultant, made the case that low bioavailability does not necessarily indicate a lack of efficacy.
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