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Walsh et al

Metabolic Pharmaceuticals chose oral dosing to differentiate their product from injectable GH therapies, but the pharmacokinetics worked against them

"We emphasize that as the clinical investigator, it is your responsibility to ensure that studies are conducted in accordance with the investigational plan, both to protect the rights, safety, and welfare of subjects and to ensure the integrity of study data." FDA noted that two of the nine randomized subjects who received the investigational product were not eligible under the enrollment criteria

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