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Estimation of absorption rate constant in a one-compartment model with the profile of the bioavailable dose eliminated as a function of multiples of half-life

โœ Scribed by P. Macheras; M. Symillides; C. Reppas


Publisher
John Wiley and Sons
Year
1993
Tongue
English
Weight
315 KB
Volume
82
Category
Article
ISSN
0022-3549

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โœฆ Synopsis


In a recent study, Chen and Pelsorl reevaluated the applicability of the half-life approach in the assessment of the relative extent of drug absorption for bioavailabilityl bioequivalence studies. This approach is based on the comparisons of the truncated areas under the curve (AUCs; that is, AUC, ) whenever the AUC of the plasma concentration versus time from zero to infinity (AUC,,) cannot be determined accurately. It was shown that the partial area comparisons can be used reliably for bioequivalence evaluation under certain conditions. This conclusion was derived1 from simulation studies focusing on the calculation of the quotient AUC,JAUC,-, at various times, expressed as multiples (n)


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Data are mean predicted k values. Conditions: (A) nine data sets, 10% random error; (6) six data sets, 20% random error; (C) nine data sets, limited Cand t,10% random error. The real value of k for conditions A-C is 0.5. Values in parentheses are coefficients of variation; ranges are ranges of predi