595-607 Obtaining clinical efficacy Explicitly recognize data in children is difficult in the document in general and will be that the primary exceptionally difficult in goal of the pediatric settings where only limited development clinical data can be program is to produced even in adults. generate data defining dosing regimens that generate appropriate PK.
595-607 Obtaining clinical efficacy data in children is difficult in general and will be exceptionally difficult in settings where only limited clinical data can be produced even in adults. Explicitly recognize in the document that the primary goal of the pediatric development program is to generate data defining dosing regimens that generate appropriate PK.