YAKHAK HOEJI (약학회지)

The Pharmaceutical Society of Korea (대한약학회)
권호 표지

Analysis of Bioequivalence Study using a Log-transformed Model

로그변환 모델에 따른 생물학적 동등성 판정 연구

  • Published : 2000.08.01
Download PDF
⟨ Previous Next ⟩

Abstract

Logarithmic transformation of pharmacokinetic parameters is routinely used in bioequivalence studies based on pharmacokinetic and statistical grounds by the United States Food and Drug Administration (FDA), European Committee for Proprietary Medicinal Products (CPMP), and Japanese National Institute of Health and Science (NIHS). Although it has not yet been recommended by the Korea Food and Drug Administration (KFDA), its use is becoming increasingly necessary in order to harmonize with international standards. In the present study, statistical procedures for the analysis of a bioequivalence based on the log transformation and a related SAS procedure were demonstrated in order to aid the understanding and application. The AUC parameters used in this demonstration were taken from the previous bioequivalence study for two aceclofenac tablets, which were performed in a single-dose crossover design. Analysis of variance (ANOVA), statistical power to detect 20% difference between the tablets, minimum detectable difference and confidence intervals were all assessed following log-transformation of the data. Bioequivalence of two aceclofenac tablets was then estimated based on the guideline of FDA. Considering the international effort for harmaonization of guidelines for bioequivalence tests, this approach may require a further evaluation for a future adaptation in the Korea Guidelines of Bioequivalence Tests (KGBT).

Keywords

References

  1. 식품의약품 안전청 고시 제 1998-86호 생물학적 동등성 시험기준
  2. J. Kor. Pharm. Sci. v.19 Bioequivalence test of slow-release theophylline dosage forms using saliva samples Shim, C.K.;Kwon, H.L.;Lee, C.K.;Han, I.S.;Choi, K.S.
  3. Arch. Pharm. Res. v.18 Bioequivalence study of nabumetone tablets in man Lee, Y.J.;Jang, E.J.;Lee, J.U.;Han, Y.H.;Chung, S.J.;Lee, M.H.;Shim, C.K.
  4. 개인적 조회(2000. 6 현재) 식약청
  5. J. Pharmacokinet. Biopharm v.15 A comparison of the two onesided tests procedure and the power approach for assessing the equivalence of average bioavailability Schuirmann, D.J.
  6. CPMP(Committee for Proprietary Medicinal Products) Working Party in the Efficacy of Medicinal Products Note for Guidance, Investigation of Bioavailability and Bioequivalence Commission of the European Communities
  7. Drugs made in Germany v.30 APV guideline: Studies on Bioavailability and Bioequivalence
  8. Division of Bioequivalence Guidance on Statistical Procedures for Bioequivalence Studies using Standard Two-treatment Crossover Design Food and Drug Administration (FDA)
  9. Guideline for Bioequivalence Studies of Generic products The National Institute of Health Sciences
  10. Int. J. Clin. Pharmacol. Ther. v.36 Bioequivalence of Neoplanta capsule to Sandimmune Neoral, microemulsion formulations of cyclosporin A in human subjects Lee, Y.J.;Chung, S.J.;Shim, C.K.
  11. Int. J. Clin. Pharmacol. Ther. Bioequivalence Assessment of Closerin Capsule to Dura Seromycin Capsule of Cycloserine after a Single Oral Dose Administration to Healthy Male Volunteers Kim, Y.G.;Lee, Y.J.;Lee, E.D.;Lee, S.D.;Kwon, J.W.;Kim, W.B.;Shim C.K.;Lee, M.G.
  12. Bioequivalence test of aceclofenac tablets Han K.S.;Lee, M.G.
  13. 醫藥品のバイオアベイラビリティと 生物學的同等性試驗 Okada H.;Samezima M.
  14. J Pharm. Sci. v.82 Logarithmic transformation in bioequivalence;application with two formulations of perphenazine Midha, K.K.;Ormsby, E.D.;Hubbard, J.W.;McKay, G.;Hawes, E.M.;Gavalas, L.;McGilveray, I.J.
  15. Int. J. Clin. Pharmacol. Ther. Toxicol. v.29 Striving for standards in bioequivalence assessment;a review Schulz, H.U.;Steinijans, V.W.
  16. Design and analysis of bioavailability and bioequivalenc studies Liu, J.P.;Chow, S.C.
  17. J. Kor. Pharm. Sci. v.28 Statistical analysis of three sequence-three periods bioequivalence study;application to bioequivalence test of ondansetron formulations Lee, Y.J.;Lee, M.G.;Chung, S.J.;Lee, M.H.;Shim, C.K.
  18. Int. J. Clin. Pharmacol. Ther. Toxiaol. v.28 A distribution-free procedure for the statistical analysis of bioequivalence studies Hauschke, D.;Steinjans, V.W.;Diletti, E.
  19. Pharmacon v.23 생물학적 동등성 기법에 활용되는 통계적 기법 김병수;서우종
  20. Clin. Pharmacokinet v.22 Controversies in bioequivalence studies Steinjans, V.W.;Hauschke, D.;Jonkman, J.H.