Regulatory Science in Neonates: A Framework That Supports Evidence-Based Drug Therapy
Turner MA, Portman RJ, Davis JM. Regulatory Science in Neonates: A Framework That Supports Evidence-Based Drug Therapy. JAMA pediatrics. 2017 Jun 12.
Development of a Harmonized Patient-Reported Outcome Questionnaire to Assess Myelofibrosis Symptoms in Clinical Trials
Gwaltney C, Paty J, Kwitkowski VE, Mesa RA, Dueck AC, Papadopoulos EJ, Wang L, Feliciano J, Coons SJ. Development of a Harmonized Patient-Reported Outcome Questionnaire to Assess Myelofibrosis Symptoms in Clinical Trials. Leukemia Research. 2017;59:26–31.
Challenges and Opportunities to Enhance Global Drug Development in Neonates
Smith AM, Davis JM. Challenges and Opportunities to Enhance Global Drug Development in Neonates. Current Opinion in Pediatrics. 2017 Apr;29(2):149–52.
Safety, Dosing, and Pharmaceutical Quality for Studies That Evaluate Medicinal Products (including Biological Products) in Neonates
Ward RM, Benjamin D, Barrett JS, Allegaert K, Portman R, Davis JM, Turner MA, and the International Neonatal Consortium. Safety, Dosing, and Pharmaceutical Quality for Studies That Evaluate Medicinal Products (including Biological Products) in Neonates. Pediatric Research. 2017 Mar 1.
Validity of the Symbol Digit Modalities Test as a Cognition Performance Outcome Measure for Multiple Sclerosis
Benedict RH, DeLuca J, Phillips G, LaRocca N, Hudson LD, Rudick R, Multiple Sclerosis Outcome Assessments Consortium. Validity of the Symbol Digit Modalities Test as a Cognition Performance Outcome Measure for Multiple Sclerosis. Multiple Sclerosis Journal (Houndmills, Basingstoke, England). 2017 Feb 1, Vol.23(5)721-733.