Corpus ID: 57079971

Bioequivalence: An overview of statistical concepts

@article{Rani2004BioequivalenceAO,
  title={Bioequivalence: An overview of statistical concepts},
  author={S. Rani and A. Pargal},
  journal={Indian Journal of Pharmacology},
  year={2004},
  volume={36},
  pages={209-216}
}
Bioequivalence (BE) means the absence of a greater-than-allowable difference between the systemic bioavailability of a test product and that of a reference product. Studies to test the BE of drug products, and the statistical basis for their design, analysis and interpretation, have evolved over the last two decades. A crossover design is preferred over a parallel-group design as it segregates the inter-subject variation (which is not product-dependent) from the intra-subject variation (which… Expand
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References

SHOWING 1-10 OF 25 REFERENCES
A comparison of the Two One-Sided Tests Procedure and the Power Approach for assessing the equivalence of average bioavailability
TLDR
This Power Approach is compared to another statistical approach, the Two One-Sided Tests Procedure, which leads to the same conclusion as the approach proposed by Westlake (2), based on the usual (shortest) 1–2α confidence interval for the true average difference. Expand
Sample size determination for bioequivalence assessment by means of confidence intervals.
TLDR
Following the approach of Phillips [1990] for the additive model, corresponding nomograms for the more relevant multiplicative model are given in this paper for various ratios of the expected means for test and reference and various coefficients of variation. Expand
Bioavailability--a problem in equivalence.
TLDR
Some statistical aspects of bioavailability are presented, which include the statistical considerations for designing and analyzing bioavailability studies, and various statistical approaches listed. Expand
A new statistical procedure for testing equivalence in two-group comparative bioavailability trials
TLDR
A simple t-test procedure for these hypotheses has been devloped that is more powerful than the methods based on usual and symmetric confidence intervals, and an example is given, including the method for sample size determination. Expand
THE TWO-PERIOD CHANGE-OVER DESIGN AN ITS USE IN CLINICAL TRIALS.
TLDR
This comparison shows that the two-period changeover design is preferable when the residual effects of the treatments are equal and the correlation between the response to the two tieatments is positive, otherwise the design in which there is random assignment to a single treatment is preferable. Expand
Sample size determination for bioequivalence assessment using a multiplicative model
TLDR
In bioequivalence studies Cmax and AUCserve are used as the primary pharmacokinetic characteristics of rate and extent of absorption because their distribution corresponds to a multiplicative model, which implies a logarithmic normal distribution in the case of a parametric analysis. Expand
Symmetrical confidence intervals for bioequivalence trials.
TLDR
This modification has the effect of decreasing the "effective" length of the confidence interval, on which the decision concerning bioequivalence is based, while increasing the confidence coefficient. Expand
Bioavailability of diphenylhydantoin
TLDR
Although DPH follOWing treatment A was absorbed more rapidly, prodUCing higher initial plasma levels than treatments B and D, the areas under the curves for the three treatments were equivalent. Expand
A COMPARATIVE STUDY OF SOME BRANDS OF TOLBUTAMIDE AVAILABLE IN CANADA. II. PHARMACEUTICAL ASPECTS.
TLDR
The evidence does not suggest that most of the non-proprietary products available in Canada would not be satisfactory for the purpose intended, and tolbutamide was found to be satisfactory with respect to identity and strength. Expand
In vitro and in vivo availability of commercial prednisone tablets.
TLDR
It is suggested that differences in in vivo rates of appearance of prednisolone in plasma correlate with in vitro rates of dissolution. Expand
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