지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
논문 기본 정보
- 자료유형
- 학술저널
- 저자정보
- 저널정보
- 대한약리학회 The Korean Journal of Physiology & Pharmacology The Korean Journal of Physiology & Pharmacology 제25권 제6호
- 발행연도
- 2021.10
- 수록면
- 545 - 553 (9page)
- DOI
- 10.4196/kjpp.2021.25.6.545
이용수
초록· 키워드
오류제보하기
Fixed-dose combinations development requires pharmacokinetic drugdrug interaction (DDI) studies between active ingredients. For some drugs, pharmacokinetic properties such as long half-life or delayed distribution, make it difficult to conduct such clinical trials and to estimate the exact magnitude of DDI. In this study, the conventional (non-compartmental analysis and bioequivalence [BE]) and modelbased analyses were compared for their performance to evaluate DDI using amlodipine as an example. Raw data without DDI or simulated data using pharmacokinetic models were compared to the data obtained after concomitant administration.
Regardless of the methodology, all the results fell within the classical BE limit. It was shown that the model-based approach may be valid as the conventional approach and reduce the possibility of DDI overestimation. Several advantages (i.e., quantitative changes in parameters and precision of confidence interval) of the model-based approach were demonstrated, and possible application methods were proposed.
Therefore, it is expected that the model-based analysis is appropriately utilized according to the situation and purpose.
목차
등록된 정보가 없습니다.
참고문헌 (15)
참고문헌 신청
Düsing R / 2010 / Optimizing blood pressure control through the use of fixed combinations / Vasc Health Risk Manag 6:321~325
Lin CP / 2020 / Fixed-dose combination of amlodipine and atorvastatin improves clinical outcomes in patients with concomitant hypertension and dyslipidemia / J Clin Hypertens(Greenwich) 22:1846~1853
Simons LA / 2017 / Long-term persistence with singlepill, fixed-dose combination therapy versus two pills of amlodipine and perindopril for hypertension : Australian experience / Curr Med Res Opin 33:1783~1787
U.S. Food and Drug Administration / Amlodipine prescribing information
U.S. Food and Drug Administration / Clinical drug interaction studies — cytochrome P450 enzyme- and transporter-mediated drug interactions guidance for industry
Lin CP / 2020 / Fixed-dose combination of amlodipine and atorvastatin improves clinical outcomes in patients with concomitant hypertension and dyslipidemia / J Clin Hypertens(Greenwich) 22:1846~1853
Simons LA / 2017 / Long-term persistence with singlepill, fixed-dose combination therapy versus two pills of amlodipine and perindopril for hypertension : Australian experience / Curr Med Res Opin 33:1783~1787
U.S. Food and Drug Administration / Amlodipine prescribing information
U.S. Food and Drug Administration / Clinical drug interaction studies — cytochrome P450 enzyme- and transporter-mediated drug interactions guidance for industry
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