pediatric PK studies for pediatric exclusivity

From: "Parasrampuria, Dolly [MCCUS]" DParasr@MCCUS.JNJ.com Subject: [NMusers] pediatric PK studies for pediatric exclusivity Date: Fri, December 10, 2004 9:13 am Hello: I wanted to get some input from the group regarding pediatric PK study designs that are required for pediatric exclusivity. If a study is required in a pediatric population (eg. adolescent) that either does not require a clinical study due to sound basis of disease similarity in adults and children or the opportunity to partner in clinical program has passed - what kind of a pediatric study design should one use? Assuming that this study needs to be conducted in healthy children and the drug has a relatively long half life of about 12 to 24 hours A traditional PK study with 8 or more blood draws, (approx sample size 24) OR A population PK approach with a slightly larger sample size but significantly less number of samples (approx sample size of 36 to 48) There are trade-offs for both approaches - cost (pop PK being more expensive than traditional PK; ethical sensitivities and considerations) and enrollment (more will be needed for pop PK) versus reduced number of blood draws and decreased discomfort/distress, potentially easier IRB approval (for pop PK) Appreciate feedback from the group. Best Regards Dolly __________________________________________________ Dolly A. Parasrampuria, PhD Clinical Pharmacology, M/C 263 McNeil Consumer & Specialty Pharmaceuticals 7050 Camp Hill Rd, Fort Washington PA 19034-2299 Tel: 215-273-7760 Fax: 215-273-4127