Case Study
Collaboration Advances Small Pharma Company’s Pediatric Development Plan to First-in-Pediatrics RSV Study
Collaboration Advances Small Pharma Company’s Pediatric Development Plan to First-in-Pediatrics RSV Study
CASE STUDY Collaboration Advances Small Pharma Company’s Pediatric Development Plan to First-in-Pediatrics RSV StudyCollaboration Advances Small Pharma Company’s Pediatric Development Plan to First-in-Pediatrics RSV Study Regions We anticipate sites in the following regions: North America Latin America Western Europe Central Europe Eastern Europe South Africa Study Duration 24 months Patient Population 88 hospitalized or non- hospitalized infants and children, aged 28 days to 24 months, with an RSV- associated respiratory tract infection, and who test positive for RSV based on an approved diagnostic assay. Primary Endpoints • To evaluate the pharmacokinetics of the study drug • To evaluate the antiviral activity of the study drug PRA Services Center for Global Dru