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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

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

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