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First-in-human clinical trials, also known as FIH trials, are studies during which a drug is administered to humans for the first time after its testing in in vitro and in vivo preclinical, experimental models

FDA reviewers, applying the statutory framework under 21 CFR 216.23(c), identified only one human study for BPC-157's proposed indication of ulcerative colitis: a decades-old meeting abstract that was never published as a peer-reviewed trial and that used an oral route of administration not the injectable or subcutaneous routes that wellness clinics commonly use

Worked example: a 10 mg peptide vial reconstituted with 2 mL of bacteriostatic water gives 5 mg per mL

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Habitual intake of dietary flavonoids and risk of Parkinson disease