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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...

March 10, 2019

Directional inconsistency between Response Evaluation Criteria in Solid Tumors (RECIST) time to progression and response speed and depth

February 23, 2019

Investigating the Value of Urine Volume, Creatinine, and Cystatin C for Urinary Biomarkers Normalization for Drug Development Studies

February 16, 2019

Recommendations for the Design of Therapeutic Trials for Neonatal Seizures

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