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Improving Pharmaceutical Product Development and Manufacturing: Impact on Cost of Drug Development and Cost of Goods Sold of Pharmaceuticals

Journal of pharmaceutical innovation, v.3 no.3, 2008년, pp.175 - 187  

Suresh, Pradeep ,  Basu, Prabir K.

초록이 없습니다.

참고문헌 (30)

  1. Chem Eng Prog PK Basu 94 75 1998 Basu PK. Pharmaceutical process development is different. Chem Eng Prog 1998;94:75-82. 

  2. G Pisano 1997 The development factory: unlocking the potential of process innovation Pisano G. The development factory: unlocking the potential of process innovation. Boston: Harvard Business School Press; 1997. 

  3. Leila A, Henry S. New prescriptions for drug makers: update the plants. Wall Street Journal, September 12, 2003. 

  4. US Department of Health and Drug Administration 2004 Challenge and opportunity on the critical path to new medical products US Department of Health and Drug Administration. Challenge and opportunity on the critical path to new medical products. Rockville: US Department of Health and Drug Administration; 2004. March. 

  5. Cohen N. PAT: process analytical technology as FDA and industry effort. In: ISPE Midwest Chapter Meeting, 2005. 

  6. Hussain A. The process analytical technology initiative: PAT and pharmacopeias. In: EDQM Spring Conference, Cannes, 2004. 

  7. Hussain A. ACPS Meeting, 2001. 

  8. Woodcock J. Issues in drug quality regulation. March 12, 2002. 

  9. NIPTE 2008 Strategic roadmap for pharmaceutical technology NIPTE. Strategic roadmap for pharmaceutical technology. Des Plaines: NIPTE; 2008. 

  10. Drug Information J. JA Vernon 41 229 2007 10.1177/009286150704100217 Vernon JA, Hughen KW, Trujilli AJ. Pharmaceutical manufacturing efficiency, drug prices, and public health: examining the casual links. Drug Information J. 2007;41:229-39. 

  11. J Health Econ. JA Dimasi 22 151 2003 10.1016/S0167-6296(02)00126-1 Dimasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ. 2003;22:151-85. 

  12. J Health Econ. JA Dimasi 10 107 1991 10.1016/0167-6296(91)90001-4 Dimasi JA, Hansen RW, Grabowski HG. Cost of innovation in the pharmaceutical industry. J Health Econ. 1991;10:107-42. 

  13. Health Aff C Adams 25 420 2006 10.1377/hlthaff.25.2.420 Adams C, Brantner VV. Estimating the costs of new drug development: is it really $802 million. Health Aff 2006;25:420-8. 

  14. M Matthews Jr 2001 From inception to ingestion: the cost of creating new drugs, ideas Matthews M Jr. From inception to ingestion: the cost of creating new drugs, ideas. Bradford: Institute of Pharmaceutical Innovation; 2001. September. 

  15. In ViVo J Gilbert 21 10 2003 Gilbert J, Singh A, Henske P. Rebuilding Big Pharma’s business model. In ViVo 2003;21:10. November, windhover.com. 

  16. Pharmacoeconomics. HG Grabowski 20 Suppl 3 11 2002 10.2165/00019053-200220003-00002 Grabowski HG, Vernon JA, Dimasi JA. Returns on research and development for 1990s new drug introductions. Pharmacoeconomics. 2002;20(Suppl 3):11-29. 

  17. Discov Med. M Dickson 4 172 2001 Dickson M, Gagnon JP. The cost of new drug discovery and development. Discov Med. 2001;4:172-9. June. 

  18. Said HC. New frontiers in pharma R&D and India’s strengths in new drug discovery. In INDIA CHEM 2002; 2003 (Former Managing Director, Pfizer India). 

  19. P Tollman 2002-2003 Pharmaceutical R&D statistical sourcebook Tollman P, Guy P, Altshuller J, et al. A revolution in R&D: how genomics and genetics will affect drug development costs and times. In: B. C. Group, editor. Pharmaceutical R&D statistical sourcebook. Boston: BCG; 2002-2003. 

  20. K McCormick 2003 Manufacturing in global pharmaceutical industry McCormick K. Manufacturing in global pharmaceutical industry. London: Urch; 2003. 

  21. Pharmaceutical Engineering RS Benson 24 26 2004 Benson RS, McCabe JDJ. From good manufacturing practices to good manufacturing performance. Pharmaceutical Engineering 2004;24:26-34. July/August. 

  22. Raju GK. FDA Science Board Meeting. 2001. 

  23. D Dean 2005 Metamorphosis of manufacturing Dean D, Bruttin F. Armonk: Metamorphosis of manufacturing; IBM Business Consulting Services; 2005. 

  24. Hussain A. Final report on PAT and manufacturing science. In FDA Science Board Meeting, 2004. 

  25. Migliaccio G. FDA will seek consultant help in implementing quality initiative. The GoldSheet, vol. 36, September 2002. 

  26. PDA J Pharm Sci. D Dean 54 253 2000 Dean D, Bruttin F. The risks and economics of regulatory compliance. PDA J Pharm Sci. 2000;54:253-63. May-Jun. 

  27. Health Aff. UE Reinhardt 20 136 2001 10.1377/hlthaff.20.5.136 Reinhardt UE. Perspectives on the pharmaceutical industry. Health Aff. 2001;20:136-49. September/October. 

  28. J Pharmaceut Innov. PK Basu 3 30 2008 10.1007/s12247-008-9024-4 Basu PK, Joglekar G, Rai S, Suresh P, Vernon JA. Analysis of manufacturing costs in pharmaceutical companies. J Pharmaceut Innov. 2008;3:30-40. March. 

  29. M Holcomb 2008 Value of implementing quality by design for the pharmaceutical industry Holcomb M, Rutten P, Fuhr T, Basu PK. Value of implementing quality by design for the pharmaceutical industry. Rockville: FDA; 2008. 

  30. J Pharmaceut Innov. RP Codgill 2 38 2007 10.1007/s12247-007-9007-x Codgill RP, Knight TP, Anderson CA, Drennen JK. The financial returns on investments in process analytical technology and lean manufacturing: benchmarks and case study. J Pharmaceut Innov. 2007;2:38. 

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