Modeling and simulation for medical product development and evaluation: highlights from the FDA-C-Path-ISOP 2013 workshop

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• 作者：Klaus Romero (1)
  Vikram Sinha (2)
  Sandra Allerheiligen (3)
  Meindert Danhof (4)
  Jose Pinheiro (5)
  Naomi Kruhlak (2)
  Yaning Wang (2)
  Sue-Jane Wang (2)
  John-Michael Sauer (6)
  J. F. Marier (7)
  Brian Corrigan (8)
  James Rogers (9)
  H. J. Lambers Heerspink (10)
  Tawanda Gumbo (11)
  Peter Vis (12)
  Paul Watkins (13)
  Tina Morrison (2)
  William Gillespie (9)
  Mark Forrest Gordon (14)
  Diane Stephenson (6)
  Debra Hanna (6)
  Marc Pfister (15)
  Richard Lalonde (8)
  Thomas Colatsky (2)
  
• 关键词：Regulatory science ; Modeling and simulation ; Quantitative drug development ; Pre ; competitive research ; (Q)SAR ; Pharmacometrics ; Biostatistics
• 刊名：Journal of Pharmacokinetics and Pharmacodynamics
• 出版年：2014
• 出版时间：December 2014
• 年：2014
• 卷：41
• 期：6
• 页码：545-552
• 全文大小：154 KB
• 参考文献：1. Food and Drug Administration (2004) Innovation or stagnation: challenges and opportunity on the critical path to new medical products, Accessed online 26 Feb 2013: http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077262.htm
  2. Kruhlak NL, Benz RD, Zhou H, Colatsky TJ (2012) (Q)SAR modeling and safety assessment in regulatory review. Clin Pharmacol Ther 91:529-34 CrossRef
  3. Wang SJ, Hung HM (2013) Adaptive enrichment with subpopulation selection at interim: methodologies, applications and design considerations. Contemp Clin Trials 36:673-81 CrossRef
  4. Avalide drug label, updated in 2012. http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020758s064lbl.pdf
  5. Food and Drug Administration (2010) Guidance for Industry: qualification process for drug development tools. Accessed online 3 Apr 2013 at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM230597.pdf
  6. Smink PA, Miao Y, Eijkemans MJ, Bakker SJ, Raz I et al (2014) The importance of short-term off-target effects in estimating the long-term renal and cardiovascular protection of Angiotensin receptor blockers. Clin Pharmacol Ther 95:208-15 CrossRef
  7. Gumbo T, Dona CS, Meek C, Leff R (2009) Pharmacokinetics-pharmacodynamics of pyrazinamide in a novel in vitro model of tuberculosis for sterilizing effect: a paradigm for faster assessment of new antituberculosis drugs. Antimicrob Agents Chemother 53:3197-204 CrossRef
  8. Pasipanodya J, Gumbo T (2011) An oracle: antituberculosis pharmacokinetics-pharmacodynamics, clinical correlation, and clinical trial simulations to predict the future. Antimicrob Agents Chemother 55:24-4 CrossRef
  9. Marino S, Kirschner DE (2004) The human immune response to Mycobacterium tuberculosis in lung and lymph node. J Theor Biol 227:463-86 CrossRef
  10. Marino S, El-Kebir M, Kirschner D (2011) A hybrid multi-compartment model of granuloma formation and T cell priming in tuberculosis. J Theor Biol 280:50-2 CrossRef
  11. Jacqmin P, McFadyen L, Wade JR (2010) Basic PK/PD principles of drug effects in circular/proliferative systems for disease modelling. J Pharmacokinet Pharmacodyn 37:157-77 CrossRef
  12. METAMODL http://www.metamodl.com/index.php?/page/metamodl.html
  
• 作者单位：Klaus Romero (1)
  Vikram Sinha (2)
  Sandra Allerheiligen (3)
  Meindert Danhof (4)
  Jose Pinheiro (5)
  Naomi Kruhlak (2)
  Yaning Wang (2)
  Sue-Jane Wang (2)
  John-Michael Sauer (6)
  J. F. Marier (7)
  Brian Corrigan (8)
  James Rogers (9)
  H. J. Lambers Heerspink (10)
  Tawanda Gumbo (11)
  Peter Vis (12)
  Paul Watkins (13)
  Tina Morrison (2)
  William Gillespie (9)
  Mark Forrest Gordon (14)
  Diane Stephenson (6)
  Debra Hanna (6)
  Marc Pfister (15)
  Richard Lalonde (8)
  Thomas Colatsky (2)
  
  1. Clinical Pharmacology, Critical Path Institute, 1730 East River Road, Tucson, AZ, 85718, USA
  2. US Food and Drug Administration (FDA), 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA
  3. Merck Sharp & Dohme Corp. Pharmaceutical Company, 1 Merck Dr, Whitehouse Station, NJ, 08889, USA
  4. Faculty of Science, Leiden Academic Centre for Drug Research, Pharmacology, Gorlaeus Laboratories, Einsteinweg 55, 2333 CC, Leiden, The Netherlands
  5. Janssen, 920 Route 202, Raritan, NJ, 08869, USA
  6. Critical Path Institute, 1730 East River Road, Tucson, AZ, 85718, USA
  7. Certara, 1699 S Hanley Rd, St Louis, MO, 63144, USA
  8. Pfizer, 445 Eastern Point Road, Groton, CT, 06340, USA
  9. Metrum Research Group, 2 Tunxis Road, Suite 112, Tariffville, CT, 06081, USA
  10. University Medical Center Groningen, Hanzeplein 1, 9700 RB, Groningen, The Netherlands
  11. University of Texas Southwestern Medical Center, 1801 Inwood Rd, Dallas, TX, 75235, USA
  12. Lap & P Consultants BV, Archimedesweg 31, 2333 CM, Leiden, The Netherlands
  13. The Hamner Institutes for Health Sciences, 6 Davis Dr, Research Triangle Park, NC, 27709, USA
  14. Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Road, Ridgefield, CT, 06877, USA
  15. University of Basel, Petersplatz 1, 4003, Basel, Switzerland
  
• ISSN：1573-8744

文摘

Medical-product development has become increasingly challenging and resource-intensive. In 2004, the Food and Drug Administration (FDA) described critical challenges facing medical-product development by establishing the critical path initiative [1]. Priorities identified included the need for improved modeling and simulation tools, further emphasized in FDA’s 2011 Strategic Plan for Regulatory Science [Appendix]. In an effort to support and advance model-informed medical-product development (MIMPD), the Critical Path Institute (C-Path) [www.c-path.org], FDA, and International Society of Pharmacometrics [www.go-isop.org] co-sponsored a workshop in Washington, D.C. on September 26, 2013, to examine integrated approaches to developing and applying model- MIMPD. The workshop brought together an international group of scientists from industry, academia, FDA, and the European Medicines Agency to discuss MIMPD strategies and their applications. A commentary on the proceedings of that workshop is presented here.