Drug-independent models that link biomarker response to clinical end points are critical to support early (end of phase II) clinical decisions. In oncology, change in tumor size (a biomarker of drug effect evaluated in phase II) is linked to survival (a phase III end point) in some solid tumors.
Publication: Clinical Pharmacology & Therapeutics
We identify some innovative approaches to predicting overall patient benefit from investigational drugs to support development decisions. We then illustrate calculation of a probabilistic clinical utility index (CUI), an implementation of multiattribute utility that focuses on clinical attributes.
Recently, Blake et al . ‘‘Ontogeny of dextromethorphan O- and N-demethylation in the first year of life’’ reported that CYP2D6 activity does not change with post-natal age up to 1 year. However, this conclusion, which was based on an invariant urinary dextromethorphan/dextrorphan (DM/DX) ratio over this period, is inconsistent with findings from studies in which … Continued
Recently, von Richter et al measured the content of cytochrome P450 (CYP) 3A in paired samples of human enterocytes and liver tissue. We now report calculations that we believe enhance the information contained in this study.