A Comparative Evaluation of the Ministry of Health of Turkey Guidelines with the FDA Guidance in Terms of the Statistical Evaluation of Bioavailability and Bioequivalence Studies: Scientific Letter

GÜRLER S., Yueksel K.

TURKIYE KLINIKLERI TIP BILIMLERI DERGISI, vol.28, no.5, pp.715-720, 2008 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 28 Issue: 5
  • Publication Date: 2008
  • Journal Name: TURKIYE KLINIKLERI TIP BILIMLERI DERGISI
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.715-720
  • Keywords: Biological availability, therapeutic equivalency, data interpretation
  • Dokuz Eylül University Affiliated: Yes

Abstract

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