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Phenytoin is primarily metabolized by the hepatic cytochrome P450 enzyme CYP2C9 and to a lesser extent by CYP2C19 and is particularly susceptible to inhibitory drug interactions because it is subject to saturable metabolism

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No serious side effects were reported in clinical trials

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It acknowledges that these peptides lack applicable USP monographs and are not components of FDA-approved drugs, then argues that this gap can be managed through a dosage-form-driven qualification framework rather than treated as fatal