Evaluation of biomarkers for pharmacological activity.
In recent years the cost of drug development has increased the demands on efficiency in the selection of suitable drug candidates. Biomarkers for efficacy and safety could be a plausible strategy to improve this selection process. In the present work, we focus on the study and evaluation of different physiological variables as biomarkers for pharmacological activity. We proposed three different approaches using multivariate and univariate techniques. We note that even though one could argue that the multivariate procedure is more powerful than the other alternatives, the univariate methods also offer a great flexibility to answer interesting scientific questions. The three approaches were used to analyze a crossover study involving an opioid antagonist.
Alonso
Ariel
A
Center for Statistics, Hasselt University, Diepenbeek, Belgium. ariel.alonso@uhasselt.be
Molenberghs
Geert
G
Renard
Didier
D
Darstein
Christelle
C
D000328:Adult; D000465:Algorithms; D000701:Analgesics, Opioid / Q000037:antagonists & inhibitors / Q000494:pharmacology; D015415:Biomarkers / Q000032:analysis*; D003198:Computer Simulation; D018592:Cross-Over Studies; D005283:Fentanyl / Q000037:antagonists & inhibitors / Q000494:pharmacology; D006728:Hormones / Q000097:blood; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D015999:Multivariate Analysis; D009271:Naltrexone / Q000494:pharmacology; D009292:Narcotic Antagonists / Q000494:pharmacology; D010601:Pharmacology, Clinical / Q000379:methods*; D012107:Research Design
D000701:Analgesics, Opioid; D015415:Biomarkers; D006728:Hormones; D009292:Narcotic Antagonists; D009271:Naltrexone; D005283:Fentanyl