Experimental Therapeutics by Wilkins Martin

By Wilkins Martin

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It is usual for the power calculations to require a 90% probability that a negative trial result is true and the significance level for a positive result is usually set at 1%. Another very important aspect of trial design is safety monitoring. It is routine for blood biochemistry and haematology to be monitored at intervals and all adverse events (AEs) must be reported promptly to the sponsors and by them to the regulatory authorities. ECG monitoring to detect QT prolongation is becoming a very common requirement.

16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. EXPERIMENTAL THERAPEUTICS Hu Teh-Min, Hayton WL. Allometric scaling of xenobiotic clearance: uncertainty versus universality. AAPS Pharm Sci 2001; 3:1–14. Singh SD, Williams AJ. The prevalence and incidence of medical conditions in healthy pharmaceutical company employees who volunteer to participate in medical research. Br J Clin Pharmacol 1999; 48:25–31. Merz M, Seiberling M, Hoxter G, Holting M, Wortha HP. Elevation of liver enzymes in multiple dose trials during placebo treatment: are they predictable?

Clustering of hepatotoxins based on mechanism of toxicity using gene expression profiles. Toxicol Appl Pharmacol 2001; 175:28–42. Bonate PL, Howard D. Prospective allometric scaling: does the Emperor have clothes? J Clin Pharmacol 2000; 40:665–70. 26 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. EXPERIMENTAL THERAPEUTICS Hu Teh-Min, Hayton WL. Allometric scaling of xenobiotic clearance: uncertainty versus universality. AAPS Pharm Sci 2001; 3:1–14. Singh SD, Williams AJ.

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Experimental Therapeutics by Wilkins Martin
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