Use of Partial Area under the Curve Metrics to Assess Bioequivalence of Methylphenidate Multiphasic Modified Release Formulations

Abstract

Historically, regulatory assessment of bioequivalence (BE) has relied upon the comparison of rate and extent of drug absorption between products (1). For drugs intended to be absorbed and systemically delivered to the site(s) of activity, this is generally achieved by measuring drug concentrations in an accessible biological fluid such as blood plasma… (More)
DOI: 10.1208/s12248-012-9397-7

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