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2,636 results
  • Pharmacologically pertinent period of effect (PPPE). [Journal Article]
  • PDPharmacoepidemiol Drug Saf 2019 Jan 09
  • Suissa M, LeLorier J
  • CONCLUSIONS: The 50 mg observational studies, looking at current exposure, correctively identified the almost immediate increase in risk evident in the VIGOR Kaplan-Meier curves. The absence of an immediate increase in risk shown by the APPROVE trial was also correctively identified by most observational 25 mg studies. To our knowledge no observational study was done on the long-term cardiac toxicity of the 25-mg dose. It would thus appear that the two doses of rofecoxib have different PPPEs.
  • Beware of on-treatment safety analyses. [Journal Article]
  • CTClin Trials 2019; 16(1):63-70
  • Yang F, Wittes J, Pitt B
  • CONCLUSIONS: For major safety outcomes in long-term clinical trials, intention-to-treat analysis should be performed in the framework of benefit-risk evaluation. More generally, analyses of safety should be tailored to the specific question being asked with the specific study design under consideration. On-treatment analyses are subject to bias; however, the direction of that bias is not necessarily clear.
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