Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design
Methodological detailspublic workshop, 4 sessions including panel discussions, Public workshop "Accelerating Drug Development for polyarticular juvenile idiopathic arthritis (pJIA)" held by the FDA with the University of Maryland Center for Regulatory Science and Innovation, October 2, 2019
- Public workshop
- 4 sessions including panel discussions
- Public workshop "Accelerating Drug Development for pJIA" held by the FDA with the University of Maryland Center for Regulatory Science and Innovation, October 2, 2019
Recommendations
As issued by the authors
Appropriate application of innovative approaches, including extrapolation, to the development of pJIA therapeutics to provide timely access to newer safe and effective treatments
Long-term safety cannot be fully extrapolated from adult studies but requires consistent postmarketing long-term follow-up
Original publication
Therapeutic Development in Polyarticular Course Juvenile Idiopathic Arthritis: Extrapolation, Dose Selection, and Clinical Trial Design. Arthritis Rheumatol. Published 3 August 2023. doi:10.
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