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2009, Number 6

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Rev Fac Med UNAM 2009; 52 (6)

Developing phases of new medicaments

Magos GGA, Lorenzana-Jiménez M

Language: Spanish
References: 28
Page: 260-264
PDF size: 80.07 Kb.


Text Extraction

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REFERENCES

  1. Antal J. Take-over of the risk-benefit by the clinical study subject and its regulation. Orv Hetil 2005; 146(26): 1399-404.

  2. Anonymous. WMA 2000 Declaration of Helsinki. Ethical principles for medical research involving human subjects. JAMA 2000; 284: 3043-45.

  3. Atuah KN, Hughes D, Pirmohamed M. Clinical pharmacology: special safety considerations in drug development and pharmacovigilance. Drug Saf 2004; 27(8): 535-54.

  4. Bhattaram VA, Bonapace C, Chilukuri DM, Duan JZ, Garnett C, Gobburu JV, Jang SH, Kenna L, Lesko LJ, Madabushi R, Men Y, Powell JR, Qiu W, Ramchandani RP, Tornoe CW, Wang Y. Zheng JJ. 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 2007; 81(2): 213-21.

  5. Cahana A, Romagnioli S. Not all placebos are the same: a debate on the ethics of placebo use in clinical trials versus clinical practice. J Anesth 2007; 21(1): 102-5.

  6. Castel JM, Figueras A, Vigo JM. The internet as a tool in clinical pharmacology. Br J Clin Pharmacol 2006; 61(6): 787-90.

  7. Chawla PS, Kochar MS. What’s new in clinical pharmacology and therapeutics. WMJ 2006; 105(3): 24-9.

  8. Dal-Re R, Costa J. Informing clinical trials participants about the results. Med Clin 2007; 128(10): 375-8.

  9. Day S, Green S, Machin D. (eds). Textbook of clinical Trials. New York: John Wiley & Sons, 2004.

  10. Dickson M, Gagnon JP. Key factors in the rising cost of new drug discovery and development. Nat Rev Drug Discov 2004; 3: 417-429.

  11. DiMasi JA. New drug development in the United States from 1963 to 1999. Clin Pharmacol Ther 2001; 69: 286-296.

  12. Evans WE, Relling MV. Moving towards individualized medicine with pharmacogenomics. Nature 2004, 429: 464-468.

  13. Giacinti L, Lopez M, Giordano A. Clinical trials. Front Biosci 2006; 11: 2918-23.

  14. Gray JD, Danoff D, Shepherd AM. Clinical pharmacology education: looking into the future. Clin Pharmacol Ther 2007; 81(2): 305-8.

  15. Herman ZS. Progress and dilemma of contemporary clinical pharmacology. Int J Clin Pharmacol Ther 2005; 43(1): 43-50.

  16. Huang SM, Temple R. Throckmorton DC, Lesko LJ. Drug interaction studies: study design, data analysis, and implications for dosing and labeling. Clin Pharmacol Ther. 2007; 81(2): 298-304.

  17. Katz R. FDA: evidentiary standards for drug development and approval. Neuro Rx. 2004; 1(3): 307-16.

  18. Knowles J, Gromo G. Target selection in drug discovery. Nat Rev Drug Discov 2003; 2(1): 63-69.

  19. Kuhlmann J. Clinical-pharmacological aspects to accelerate the development process from the preclinical to the clinical phase/2nd communication: promising strategies. Arzneimittelforschung 2004; 54(6): 307-13.

  20. Lemaire F. Patient care versus research: does clinical research provide individual benefit to patients enrolled in trials?. Curr Opin Crit Care 2004; 10(6): 565-9.

  21. Lesko LJ. Paving the critical path: how can clinical pharmacology help achieve the vision? Clin Pharmacol Ther 2007; 81(2): 170-7.

  22. Moscucci M et al. Blinding, unblinding, and the placebo effects: An analysis of patients´ guesses of treatment assignment in a double-blind clinical trial. Clin Pharmacol Ther 1987; 43: 290.

  23. Peck C. Preventing post marketing changes in recommended doses and marketing withdrawals. Ernst Schering Res Found Worksho 2007; (59): 209-16.

  24. Reichert JM. Trends in development and approval times for new therapeutics in the United States. Nat Rev Drug Discov 2003; 2: 695-702.

  25. Sakamoto J, Morita S. From translational research to a large randomized clinical trial: a long and strenuous way from bench to bedside. Nagoya J Med Sci 2007; 69(1-2): 9-16.

  26. Shaughnessy M, Beidler SM, Gibbs K, Michael K. Confidentiality challenges and good clinical practices in human subjects research: striking a balance. Top Stroke Rehabi 2007; 14(2): 1-4.

  27. Shulman, SR, Hewitt P, Manocchia M. Studies and inquiries into the FDA regulatory process: a historical review. Drug Inf J 1993; 29: 385.

  28. World Medical Association Declaration of Helsinki (1996) http://www.va.gov/over/docs/compendium_1/files Helsinki 96 htm.




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