References
- 박상규, 남봉현, 정윤노, 이재영, 정규진 (2010). 생물학적 동등성 시험의 추가시험에 대한 통계적 고찰, 한국통계학회논문집, 17, 107-115. https://doi.org/10.5351/CKSS.2010.17.1.107
-
박상규, 임남규, 이재영, 김병천 (2005).
$2{\times}2$ 교차설계법에서 모집단 생물학적 동등성 검정방법 비교, 응용통계연구, 18, 1-13. https://doi.org/10.5351/KJAS.2005.18.1.159 - 식품의약품안전청 (2010). 생물학적동등성시험기준 (고시 제2010-43호).
-
정규진, 박상규, 김관엽 (2011). 공변량을 고려한
$2{\times}2$ 교차설계법에 평균 생물학적 동등성 평가, 응용통계연구, 24, 161-167. https://doi.org/10.5351/KJAS.2011.24.1.161 -
정규진, 박상규, 우화형 (2009).
$2{\times}2$ 생물학적 동등성 시험에서 이상치 검출을 위한 통계적 방법, 한국통계학회논문집, 16, 745-751. https://doi.org/10.5351/CKSS.2009.16.5.745 -
정규진, 임남규, 박상규 (2010).
$3{\times}2$ 교차설계법에서 개인 생물학적 동등성 검정, 응용통계연구, 21, 139-150. https://doi.org/10.5351/KJAS.2010.23.1.139 - Arieta, A. G. (2006). Highly variable drugs. Understanding Bioequivalence of Generic Drugs, A Worldwide Review, Monte Carlo.
- Benet, L. (1993). Bioavailability and bioequivalence: Definitions and difficulties in acceptance criteria. In Midha KK. Blume HH, editors, Bio-International 92: bioavailability, bioequivalence and pharmacokinetics, Medpharm, Stuttgart, 27-35.
- Benet, L. (1999). Individual bioequivalence: An overview, AAPS International Workshop on Individual Bioequivalence: Realities and Implementation, Montreal, Quebec.
- Benet, L. (2006). Why highly variable drugs are safer. Meeting of FDA Committee for Pharmaceutical Science, http:// www.fda.gov/ohrms/dockets/ac/06/slides/2006-4241s2_2.ppt(assessed 3/17/2011).
- Bio-international (1992). Conference on Bioavailability, Bioequivalence and Pharmacokinetic Studies, Bad Homburg, Germany, May 20-22.
- Blume, H. H. (2010). Highly variable drugs: reasons for high variability and solutions to overcome BE problems, Modern Strategies for the Development of Generic Drugs 20th AGAH Annual Meeting, Hamburg, http://www.agah.info/uploads/media/Blume_H_BE - HV D_AGAH_2010_Einleitung1.pdf (assessed 3/17/2011).
- Boddy, A. W., Snikeris, F. C., Kringle, R. O., Wei, G. C. G., Oppermann, J. A. and Midha, K. K. (1995). An approach for widening the bioequivalence acceptance limits in the case of highly variable drugs, Pharmaceutical Research, 12, 1865-1868. https://doi.org/10.1023/A:1016219317744
- Chow, S. C. and Liu, J. P. (2008). Design and Analysis of Bioavailability and Bioequivalence Studies, 3rd edition, CRC press.
-
Chow, S. C., Shao, J. and Wang, H. (2002). Individual bioequivalence testing under
$2{\times}3$ designs, Statistics in Medicine, 21, 629-648. https://doi.org/10.1002/sim.1056 - Chow, S. C. and Tse, S. K. (1990). Outliers detection in bioavailability/bioequivalence studies, Statistics in Medicine, 9, 549-558. https://doi.org/10.1002/sim.4780090508
- Cohen, J. (1988). Statistical Power Analysis for the Behavioral Sciences, Lawrence Erlbaum Associates, Hillsdale, New Jersey.
- Davit, B. M. (2004). Highly variable drugs: FDA case studies. Advisory Committee for Pharmaceutical Sciences. Office of Generic Drugs. US FDA Center for Drug Evaluation and Research, http://www.fda.gov/ohrms/dockets/ac/04/slides/4034s206davit.ppt (assessed 3/17/2011)
- Davit, B. M., Conner, D. P., Fabian-Fritsch, B., Haidar, S. H., Jiang, X., Patel, D. T., Seo, P. R. H., Suh, K., Thompson, C. L. and Yu, L. X. (2008). Highly variable drugs: Observations from bioequivalence data submitted to the FDA for new generic drug applications, The AAPS Journal, 10, 148-156. https://doi.org/10.1208/s12248-008-9015-x
- DiLiberti, C. E. (2007). BE for Highly Variable Drugs an Industry Perspective, Barr Laboratories, Inc. http://www.aapspharmaceutica.com/meetings/files/90/21DiLiberti.pdf (assessed 3/17/2011).
- EMEA, European Medicines Agency, Committee for Medicinal Products for Human Use. (2008). Draft Guideline on the Investigation of Bioequivalence, London.
- EMEA, European Medicines Agency, Committee for Medicinal Products for Human Use. (2010). Draft Guideline on the Investigation of Bioequivalence, London.
- Endrenyi, L., Fritsch, S. and Van, W. (1991). Cmax/AUC is a clearer measure than Cmax for absorption rates in investigations of bioequivalence, International Journal of Clinical Pharmacology, 29, 394-399.
- Endrenyi, L. and Tothfalusi, L. (2009). Regulatory conditions for the determination of bioequivalence of highly variable drugs, Journal of the Pharmaceutical Sciences, 12, 138-149.
- Haidar, S. H., Davit, B., Chen, M. L., Conner, D., Lee, L., Li, Q. H., Lionberger, R., Makhlouf, F., Patel, D., Schuirmann, D. J. and Yu, L. X. (2008a). Bioequivalence approaches for highly variable drugs and drug products, Pharmaceutical Research, 25, 237-241. https://doi.org/10.1007/s11095-007-9434-x
- Haidar, S. H., Makhiouf, F., Schuirmann, D. J., Hyslop, T., Davit, B., Conner, D. and Yu, L. X. (2008b). Evaluation of a scaling approach for the bioequivalence of highly variable drugs, AAPS Journal, 10, 450-454. https://doi.org/10.1208/s12248-008-9053-4
- Health Canada, Ministry of Health. (1992). Guidance for industry: Conduct and analysis of bioavailability and bioequivalence studies. Part A: oral dosage formulations used for systemic effects, Ottawa, Ontario.
- Health Canada. Therapeutic Products Directorate (2003). Discussion paper on 'Bioequivalence requirements - highly variable drugs and highly variable drug products: issues and options'. Expert Advisory Committe on Bioavailability and Bioequivalence (EAC-BB) Meeting.
- Howe, W. G. (1974). Approximate confidence limits on the mean of X + Y where X and Y are two tabled independent random variables, Journal of the American Statistical Association, 69, 789-794. https://doi.org/10.2307/2286019
- Hyslop, T., Hsuan, F. and Holder, D. J. (2000). A small sample confidence interval approach to assess individual bioequivalence, Statistics in Medicine, 19, 2885-2897. https://doi.org/10.1002/1097-0258(20001030)19:20<2885::AID-SIM553>3.0.CO;2-H
- Johnson, N. L. and Kotz, S. (1970). Continuous Univariate Distributions-2, Houghton Mifflin Company, Boston.
- Karalis, V., Macheras, P. and Symillides, M. (2005). Geometric mean ratio-dependent scaled bioequivalence limits with leveling-off properties, European Journal of the Pharmaceutical Sciences, 26, 54-61. https://doi.org/10.1016/j.ejps.2005.04.019
- Karalis, V., Symillides, M. and Macheras, P. (2004). Novel scaled average bioequivalence limits based on GMR and variability considerations, Pharmaceutical Research, 21, 1933-1942. https://doi.org/10.1023/B:PHAM.0000045249.83899.ae
- Kytariolos, J., Karalis, V., Macheras, P. and Symillides, M. (2006). Novel scaled bioequivalence limits with leveling-off properties, Pharmaceutical Research, 23, 2657-2664. https://doi.org/10.1007/s11095-006-9107-1
- Liu, J. P. and Weng, C. S. (1991). Detection of outlying data in bioavailability/bioequivalence studies, Statistics in Medicine, 10, 1375-1389. https://doi.org/10.1002/sim.4780100906
- Midha, K. K. (2006). Highly Variable Drugs & Drug Products-A Rationale for Solution of a Persistent Problem, http://www.fda.gov/ohrms/DOCKETS/ac/06/slides/2006-4241s2-3.ppt (assessed 11/3/2010).
- Patterson, S. D., Zariffa, N. M. D., Montague, T. H. and Howland, K. (2001). Non-traditional study designs to demonstrate average bioequivalence for highly variable drug products, European Journal of Pharmaceutical Sciences, 57, 663-670.
- Ramsay, T. and Elkum, N. (2005). A comparison of four different methods for outlier detection in bioequivalence studies, Journal of Biopharmaceutical Statistics, 15, 43-52.
- Schall, R. and Luus, H. G. (1993). On population and individual bioequivalence, Statistics in Medicine, 12, 1109-1124. https://doi.org/10.1002/sim.4780121202
- Scheiner, L. B. (1992). Bioequivalence revisited, Statistics in Medicine, 11, 1777-1788. https://doi.org/10.1002/sim.4780111311
- Schuirmann, D. J. (1987). A comparison of two one-sided test procedures and the power approach for assessing the equivalence of average bioavailability, Journal of Pharmacokinetics and Biopharmaceutics, 15, 657-680. https://doi.org/10.1007/BF01068419
- Tanguay, M., Potvin, D., Haddad, J., Lavigne, J., Marier, J. F., DiMarco, M. and Ducharme, M. P. (2002). When will a drug formulation pass or fail bioequivalence criteria? Experience from 1200 studies, AAPS Pharmaceutical Science, 4, Abstract R6193.
- Tothfalusi, L. and Endrenyi, L. (2003). Limits for the scaled average bioequivalence of highly variable drugs and drug products, Pharmaceutical Research, 20, 382-389. https://doi.org/10.1023/A:1022695819135
- Tothfalusi, L., Endrenyi, L. and Garcia Arieta, A. (2009). Evaluation of bioequivalence for highly variable drugs with scaled average bioequivalence, Clinical Pharmacokinetics, 48-11, 725-743.
- US FDA Center for Drug Evaluation and Research. (2001). Statistical Approaches to Establishing Bioequivalence: Guidance for Industry, Rockville, Maryland.
- US Government. (2009). 21 CFR Part320 - Code of Federal Regulations Title 21-Food and Drugs, Part 320-Bioavailability and Bioequivalence Requirements. FDA Home > Medical Devices > Databases에 수록, 2009년 4월 1일 최종수정.
- Wang, W. and Chow, S. C. (2003). Examining outlying subjects and outlying records in bioequivalence trials, Journal of Biopharmaceutical Statistics, 13, 43-56. https://doi.org/10.1081/BIP-120017725
- Wellek, S. (2003). Testing Statistical Hypotheses of Equivalence, Chapman & Hall, London.
Cited by
- Assessing bioequivalence for highly variable drugs based on 3×3 crossover designs vol.29, pp.2, 2016, https://doi.org/10.5351/KJAS.2016.29.2.279
- Statistical procedures of add-on trials for bioequivalence in 2×k crossover designs vol.25, pp.6, 2014, https://doi.org/10.7465/jkdi.2014.25.6.1181
- Some Statistical Considerations on 2×k Crossover Designs for Bioequivalence Trial vol.26, pp.4, 2013, https://doi.org/10.5351/KJAS.2013.26.4.675