January 6, 2018 Selection of and evidentiary considerations for wearable devices and their measurements for use in regulatory decision making: recommendations from the ePRO Consortium
January 6, 2018 Informing the tolerability of cancer treatments using patient-reported outcome (PRO) measures: summary of an FDA and Critical Path Institute workshop
January 6, 2018 Genetic sequencing for surveillance of drug resistance in tuberculosis in highly endemic countries: a multi-country population-based surveillance study
January 1, 2018 Development of a symptom-focused patient-reported outcome measure for functional dyspepsia: the Functional Dyspepsia Symptom Diary (FDSD)
January 1, 2018 Performance Assessment of New Urinary Translational Safety Biomarkers of Drug-induced Renal Tubular Injury in Tenofovir-treated Cynomolgus Monkeys and Beagle Dogs
January 1, 2018 Individual serum bile acid profiling in rats aids in human risk assessment of drug-induced liver injury due to BSEP inhibition
December 22, 2017 Application of a Dynamic Map for Learning, Communicating, Navigating, and Improving Therapeutic Development
December 22, 2017 A Dynamic Map for Learning, Communicating, Navigating and Improving Therapeutic Development
December 22, 2017 Qualitative Development and Cognitive Evaluation of the Symptoms of Major Depressive Disorder (S-MDD), A Consortium-Developed Patient Reported Outcome Measure
