r Children may differ from adults r PK / PD studies with relevant biomarkers central to bridge adult safety & efficacy data to pediatrics r Appropriately applying a size adjustment approach critical in dose selection of trials & PK/PD modeling r Limited sampling design coupled with mixed effects modeling (population approach) frequently used feature in pediatric trial & data analysis r Necessity of dose adjustment for pediatric subpopulations should be judged based on whether or not PK difference will likely lead to clinically significant PD difference

Was this article helpful?

0 0
Project Management Made Easy

Project Management Made Easy

What you need to know about… Project Management Made Easy! Project management consists of more than just a large building project and can encompass small projects as well. No matter what the size of your project, you need to have some sort of project management. How you manage your project has everything to do with its outcome.

Get My Free Ebook

Post a comment