An Initial PSP is an outline of the pediatric study or studies that the drug development sponsor plans to conduct in the USA – to confirm the suitability of drug usage in the pediatric population.
Initial PSPs cover study objectives and design, age groups, relevant endpoints and statistical approach. Amended PSPs follow.
The preparation of a PSP requires concise presentation of information about the disease to be treated in children, as well as laying out all relevant current knowledge of the drug being developed, assembling a convincing rationale for the pediatric study plan proposed.
Trilogy staff have accumulated extensive experience in the preparation of plans covering a range of pediatric therapeutic areas.