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
September 3, 2019 The Qualification of an Enrichment Biomarker for Clinical Trials Targeting Early Stages of Parkinson’s Disease
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...
July 4, 2019 Summary of Torsades de Pointes (TdP) Reports Associated with Intravenous Drug Formulations Containing the Preservative Chlorobutanol
June 11, 2019 Scientific and Regulatory Considerations for the Analytical Validation of Assays Used in the Qualification of Biomarkers in Biological Matrices
May 12, 2019 Parkinson’s Progression Markers Initiative (PPMI). Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson’s Disease
March 19, 2019 The Importance of Drug Safety and Tolerability in the Development of New Immunosuppressive Therapy for Transplant Recipients
March 18, 2019 Molecular Neuroimaging of the Dopamine Transporter as a Patient Enrichment Biomarker for Clinical Trials for Early Parkinson’s Disease Romero K, Conrado D, Burton J, Nicholas T, Sinha V, Macha S, Ahamadi M, Cedarbaum J, Seibyl J, Marek K, Basseches P, Hill D...