October 22, 2019 Evaluation of multiple sclerosis disability outcome measures using pooled clinical trial data
October 9, 2019 On September 25th, the FDA published a Personal Viewpoint in the American Journal of Transplantation
September 25, 2019 Assessment of Long-term Neurodevelopmental Outcome Following Trials of Medicinal Products in Newborn Infants
September 23, 2019 Development of a Neonatal Adverse Event Severity Scale Through a Delphi Consensus Approach
September 20, 2019 The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease Stephenson D, Hill D, Cedarbaum JM, Tome M, Vamvakas S, Romero K, Conrado DJ, Dexter DT, Seibyl J, Jennings D, Nicholas T...
September 13, 2019 Symptoms of Major Depressive Disorder Scale: Performance of a Novel Patient-Reported Symptom Measure
August 14, 2019 Conrado et al. 2019 Towards Regulatory Endorsement Towards regulatory endorsement of drug development tools to promote the application of model-informed drug development in...
June 11, 2019 Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices
March 19, 2019 The Importance of Drug Safety and Tolerability in the Development of New Immunosuppressive Therapy for Transplant Recipients