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Regulatory guidance for orally administered drugs typically requires that the 90% confidence intervals for key pharmacokinetic parameters (Cmax and AUC) fall within predefined limits, commonly 80%125% of a reference product ( Numerous oral peptide programs failed not because efficacy could not be demonstrated in some patients under some conditions, but because variability precluded regulatory acceptance

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The company will also be required to pay a $25,000 civil penalty, according to board records

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