References
- FDA, Center for Drug Evaluation and Research, Guidance for Industry-Extended release oral dosage forms : development, evaluation and application of in vitro/in vivo correlation, September (1997).
- 식품의약품안전청 용역연구개발사업 : 비교용출시험과 용출규격의 상관성 연구, 사홍기 (2004).
- 식품의약품안전청 용역연구개발사업 : 의약품의 제제동등성평가 (II)-경구용 제제의 제제동등성 평가, 사홍기 (2003).
- 식품의약품안전청 용역연구개발사업 : 의약품의 제제동등성평가 (III)-경구용 제제의 제제동등성 평가, 사홍기 (2004)
- 식품의약품안전청 연구개발사업 : 의약품 규격의 국제화사업(I), 박상애, 장수현, 정혜윤, 장성재, 강신정, 장승엽, 최보경, 윤미옥, 최돈웅, 김영임, 최현철, 김호정, 김미정, 김희성, 민추익, 백경민 (2003).
- Ansel, H., Allen, Jr. L. and Popovich, N. : Pharmaceutical Dosage Forms and Drug Delivery systems (7th ed.), Lippincott Williams & Wilkins, Baltimore (1999).
- 식품의약품안전청 통계연보 (2005).
- Food and Drug Administration : Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms. US department of health and human services/Food and drug administration/Center for drug evaluation and research, Rockville MD (1997).
- 식품의약품안전청 : 경구용의약품의 용출 규격 설정 지침. 대한약전 제 9개정 (2007).
- 의약품동등성시험기준, 식품의약품안전청 고시 제2010-88호 (2010.12.3).
- Brodie, R. R., Chasseaud, L. F. and Taylor, T. : Determination of naftidrofuryl in the plasma of humans by high-performance liquid chromagography. J. Chromatogr. 164, 534 (1979). https://doi.org/10.1016/S0378-4347(00)81559-5
- Patel, B. N., Sharma, N., Sanyal, M. and Shrivastav, P. S. : An accurate, rapid and sensitive determination of tramadol and its active metabolite O-desmethyltramadol in human plasma by LC-MS/MS. J. Phram. Biomed. Anal. 49, 354 (2009). https://doi.org/10.1016/j.jpba.2008.10.030
- Walmsley, L. M., Wilkinson, P. A., Brodie, R. R. and Chasseaud, L. F. : Determination of naftidrofuryl in human plasma by high performance liquid chromatography with fluorescence detection. J. Chromatogr. 338, 433 (1985). https://doi.org/10.1016/0378-4347(85)80117-1
- Waaler, P. J. and Mueller, B. W. : Solid-phase extraction of naftidrofuryl from human plasma for high-performance liquid chromatography analysis. Int. J. Pharm. 87, 223 (1992). https://doi.org/10.1016/0378-5173(92)90246-X
- Beyer, K. H. and Hildebrand, M. : Naftidrofuryl (Dusodril). Possible uses of gas chromatography and high-pressure liquid chromatography for analysis. Deutsche Apotheker Zeitung 122, 1709 (1982).
- Garrett, E. R. and Barhaiya, R. : Prediction of stability in pharmaceutical preparations. XVIII: Application of highpressure liquid chromatographic assays to study of natronyl stability and bioanalysis. J. Pharm. Sci. 70, 39 (1981). https://doi.org/10.1002/jps.2600700106
- Gan, S. H., Ismail, R., Adnan, W. A. W. and Wan, Z. : Method development and validation of a high-performance liquid chromatographic method for tramadol in human plasma using liquid-liquid extraction. J. Chromatogr. B 772, 123 (2002).
- Zaghloul, I. Y. and Radwan, M. A. : High performance liquid chromatographic determination of tramadol in pharmaceutical dosage forms. J. Liq. Chrom. Rel. Technol. 20, 779 (1997). https://doi.org/10.1080/10826079708014142
- Gan, S. H. and Ismail, R. : Validation of a high-performance liquid chromatography method for tramadol and O-desmethyltramadol in human plasma using solid-phase extraction. J. Chromatogr. B 759, 325 (2001).
- Overbeck, P. and Blaschke, G. : Direct determination of tramadol glucuronides in human urine by high-performance liquid chromatography with fluorescence detection. J. Chromatogr. B 732, 185 (1999).
- Yeh, G. C., Sheu, M. T., Yen, C. L., Wang, Y. W., Liu, C. H. and Ho, H. O. : High-performance liquid chromatographic method for determination of tramadol in human plasma. J. Chromatogr. B 723, 247 (1999).
- Kucuk, A., Kadioglu, Y. and Celebi, F. : Investigation of the pharmacokinetics and determination of tramadol in rabbit plasma by a high-performance liquid chromatography-diode array detector method using liquid-liquid extraction. J. Chromatogr. B 816, 203 (2005).
- Ho, S. T., Wang, J., Liaw, W. J., Ho, C. M. and Li, J. H. : Determination of tramadol by capillary gas chromatography with flame ionization detection application to human. J. Chromatogr. B. 736, 89 (1999).
- 식품의약품안전청 : 의약품등 분석법의 밸리데이션에 대한 지침. 대한약전 제 9개정 (2007).