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Alfred Lagaya

How New US Regulatory Requirements Impact Early Phase Clinical Pharmacology Studies - Celerion

Updated: Aug 12, 2020



Phase 1 clinical trials aim to evaluate basic safety and tolerability of an investigational new drug product, and to determine the pharmacokinetic and pharmacologic parameters of the drug in human subjects. Challenges may be encountered when initially entering clinical development requiring adjustments to the dosage strength or formulation of the drug in order to move development forward. Join this webinar to hear how utilizing Celerion’s extemporaneous compounding capabilities can help to gain access to early human data faster.

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