효율적인 의약품 평가를 위한 약물계량학 분석법 도입의 전략 방안

키워드

참고문헌 (36)

1. Gilbert J, "Rebuilding big pharma's business model", pp.73~80 (2003), Windhover Information Inc
2. Pugsley MK, "Cardiac Drug Development Guide", pp.366~ (2003), Humana Press
3. Powell JR, "Pharmacometrics at Food and Drug Administration: evolution and impact on decisions", Clin Pharmacol Ther, 82, pp.97~102 (2007)
4. Gobburu JVS, "Model-based drug development will reduce late phase attrition to half by 2015", ASCPT annual meeting workshop (2008)
5. Bhattaram VA, "Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications", The AAPS Journal, 7, pp.503~512 (2005)
6. Bhattaram VA, "Impact of pharmacometric reviews on New Drug Approval and labeling decisions-a survey of 31 New Drug Applications submitted between 2005 and 2006", Clin Pharmacol Ther, 81, pp.213~221 (2007)
7. Goldberger M, "ASCPT Task Force for advancing pharmacometrics and integration into drug development", Clin Pharmacol Ther, 88, pp.158~161 (2010)
8. Gobburu JVS, "Pharmacometrics 2020", J Clin Pharmacol, 50, pp.151S~157S (2010)
9. "Food and Drug Administration Modernization Act of 1997", Food and Drug Administration, ~ (1997)
10. "Food and Drug Administration Critical Path Initiatives white paper: innovation or stagnation? Challenge and opportunity on the critical path to new medical products" (2004), Food and Drug Administration
11. Food and Drug Administration Critical Path opportunity report and list, , Food and Drug Administration, ~ (2006)
12. "Guidance for industry: pharmacokinetics in patients with impaired renal function ― study design, data analysis, and impact on dosing and labeling" (1998), Food and Drug Administration
13. "Guidance for industry: End-of-Phase 2A Meetings" (2009), Food and Drug Administration
14. "Guidance for industry: drug interaction studies ― study design, data analysis, and implications for dosing and labeling" (2006), Food and Drug Administration
15. "Guidance for industry: pharmacokinetics in patients with impaired hepatic function: study design, data analysis, and impact on dosing and labeling" (2003), Food and Drug Administration
16. "Guidance for industry: exposure-response relationships ― study design, data analysis, and regulatory applications" (2003), Food and Drug Administration
17. "Guidance for industry: population pharmacokinetics" (1999), Food and Drug Administration
18. "Guidance for industry: general considerations for pediatric pharmacokinetic studies for drugs and biological products" (1998), Food and Drug Administration
19. QTc interval prolongation and proarrhythmic potential for nonantiarrhythmic drugs, "Guidance for industry: E14 clinical evaluation of QT", pp.2005
22. "The European Medicines Agency road map to 2010: preparing the ground for the future" (2005), European Medicines Agency
23. Innovative drug development approaches final report from the EMEA, "CHMP-Think-Tank Group on innovative drug development", 2007
24. "Guideline on the investigation of drug interactions" (2010), European Medicines Agency
25. "Guideline on requirements for first-in-man clinical trials for potential high-risk medicinal products" (2007), European Medicines Agency
26. "Guideline on the role of pharmacokinetics in the development of medicinal products in the paediatric population" (2006), European Medicines Agency
27. "Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired hepatic function" (2005), European Medicines Agency
28. "Note for guidance on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal fuction" (2004), European Medicines Agency
29. "Note for guidance on the investigation of drug interactions" (1997), European Medicines Agency
30. "Workshop on modelling in paediatric medicines", Workshop on modelling in paediatric medicines (2008), European Medicines Agency
31. "ICH harmonised tripartite guideline: clinical investigation of medicinal products in the pediatric population E11", ICH, ~ (2001)
32. "ICH topic E4 dose response information to support drug registration", ICH, ~ (1994)
33. "Final ICH concept paper for topic E16: pharmacogenomic (PG) biomarker qualification: format and data standards", ICH, ~ (2008)
34. "Guideline on reporting the results of population phamracokinetic analyses" (2007), European Medicines Agency
35. 윤휘열, "모델 기반학적 신약개발에서 약동", 약력학 모델링 및 시뮬레이션의 역할, 2008, pp.18(2), 84~96[DOI]
36. 윤영란, "Pharmacokinetic", Pharmacodynamic 모델링의 개요: NONMEM® 소프트웨어를 이용한 Non-Linear Mixed Effects Modelling, 2006, pp.14(2), 99~105[DOI]

관련 논문AI추천