Model-based drug development.
作者： R L Lalonde , K G Kowalski , M M Hutmacher , W Ewy , D J Nichols
关键词: Drug development 、 Drug 、 Gerontology 、 Meta-Analysis as Topic 、 Cholesterol blood 、 Risk analysis (engineering) 、 Food and drug administration 、 Bridged Bicyclo Compounds 、 Business 、 Productivity 、 Erikson's stages of psychosocial development
摘要: The low productivity and escalating costs of drug development have been well documented over the past several years. Less than 10% new compounds that enter clinical trials ultimately make it to market, many more fail in preclinical stages development. These challenges "critical path" are discussed a 2004 publication by US Food Drug Administration. document emphasizes tools various opportunities improve One recommended is application "model-based (MBDD)." This paper discusses what constitutes key elements MBDD how these should fit together inform strategy decision-making.
nature.com
sci-hub.se 参考文章(23)
Bruno G. Reigner, Peter E.O. Williams, Indra H. Patel, Jean-Louis Steimer, Carl Peck, Peter van Brummelen, An Evaluation of the Integration of Pharmacokinetic and Pharmacodynamic Principles in Clinical Drug Development Experience within Hoffmann La Roche Clinical Pharmacokinectics. ,vol. 33, pp. 142- 152 ,(1997) , 10.2165/00003088-199733020-00005
Ismail Kola, John Landis, Can the pharmaceutical industry reduce attrition rates? Nature Reviews Drug Discovery. ,vol. 3, pp. 711- 716 ,(2004) , 10.1038/NRD1470
V A Bhattaram, C Bonapace, D M Chilukuri, J Z Duan, C Garnett, J V S Gobburu, S H Jang, L Kenna, L J Lesko, R Madabushi, Y Men, J R Powell, W Qiu, R P Ramchandani, C W Tornoe, Y Wang, J J Zheng, Impact of pharmacometric reviews on new drug approval and labeling decisions--a survey of 31 new drug applications submitted between 2005 and 2006. Clinical Pharmacology & Therapeutics. ,vol. 81, pp. 213- 221 ,(2007) , 10.1038/SJ.CLPT.6100051
Liping Zhang, Vikram Sinha, S. Thomas Forgue, Sophie Callies, Lan Ni, Richard Peck, Sandra R. B. Allerheiligen, Model-based drug development: the road to quantitative pharmacology. Journal of Pharmacokinetics and Pharmacodynamics. ,vol. 33, pp. 369- 393 ,(2006) , 10.1007/S10928-006-9010-8
JW Mandema, E Cox, J Alderman, Therapeutic benefit of eletriptan compared to sumatriptan for the acute relief of migraine pain – results of a model‐based meta‐analysis that accounts for encapsulation Cephalalgia. ,vol. 25, pp. 715- 725 ,(2005) , 10.1111/J.1468-2982.2004.00939.X
Venkatesh A. Bhattaram, Brian P. Booth, Roshni P. Ramchandani, B. Nhi Beasley, Yaning Wang, Veneeta Tandon, John Z. Duan, Raman K. Baweja, Patrick J. Marroum, Ramana S. Uppoor, Nam Atiqur Rahman, Chandrahas G. Sahajwalla, J. Robert Powell, Mehul U. Mehta, Jogarao V. S. Gobburu, Impact of pharmacometrics on drug approval and labeling decisions: a survey of 42 new drug applications. Aaps Journal. ,vol. 7, ,(2005) , 10.1208/AAPSJ070351
Jaap W. Mandema, David Hermann, Wenping Wang, Tim Sheiner, Mark Milad, Rebecca Bakker-Arkema, Daniel Hartman, Model-based development of gemcabene, a new lipid-altering agent. Aaps Journal. ,vol. 7, ,(2005) , 10.1208/AAPSJ070352
Scott Marshall, Fiona Macintyre, Ian James, Michael Krams, Niclas E Jonsson, Role of mechanistically-based pharmacokinetic/pharmacodynamic models in drug development : a case study of a therapeutic protein. Clinical Pharmacokinectics. ,vol. 45, pp. 177- 197 ,(2006) , 10.2165/00003088-200645020-00004
Carl C Peck, William H Barr, Leslie Z Benet, Jerry Collins, Robert E Desjardins, Daniel E Furst, John G Harter, Gerhard Levy, Thomas Ludden, John H Rodman, Lilly Sanathana, Jerome J Schentag, Vinod P Shah, Lewis B Sheiner, Jerome P Skelly, Donald R Stanski, Robert J Temple, C T Viswanathan, Judi Weissinger, Avraham Yacobi, Opportunities for integration of pharmacokinetics, pharmacodynamics, and toxicokinetics in rational drug development Clinical Pharmacology and Therapeutics. ,vol. 51, pp. 465- 473 ,(1992) , 10.1038/CLPT.1992.47
MD Ferrari, PJ Goadsby, KI Roon, RB Lipton, Triptans (serotonin, 5‐HT1B/1D agonists) in migraine: detailed results and methods of a meta‐analysis of 53 trials Cephalalgia. ,vol. 22, pp. 633- 658 ,(2002) , 10.1046/J.1468-2982.2002.00404.X