TURKIYE KLINIKLERI TIP BILIMLERI DERGISI, vol.28, no.5, pp.715-720, 2008 (SCI-Expanded)
The difference between the statistical approaches recommended in the "Statistical Evaluation on Establishing Bioavailability and Bioequivalence", an appendix of "The Regulation about Bioavailability and Bioequivalence of Pharmaceutical Preparations" which was published by the Ministry of Health of Turkey and the American Food and Drug Administration (FDA) was compared and discussed. The evaluation suggested differences between the Regulation of the Ministry of Health of Turkey and the FDA Guidelines regarding the scope of the statistical evaluation, Although the basic statistical description was included the Regulation of the Ministry of Health, the details about bioequivalence study was not denoted obviously and regularly