Stratification, Hypothesis Testing, and Clinical Trial Simulation in Pediatric Drug Development

Conclusions:
If assumptions regarding a pediatric disease process, such as KD, do not include age stratification with inclusion or response, then the wrong decision could result with regard to age-appropriateness or approval of a drug.

Source: Therapeutic Innovation and Regulatory Science - October 23, 2016 Category: Drugs & Pharmacology Authors: McMahon, A. W., Watt, K., Wang, J., Green, D., Tiwari, R., Burckart, G. J. Tags: Special Populations Source Type: research