From: "Parasrampuria, Dolly [MCCUS]"
Subject: [NMusers] pediatric PK studies for pediatric exclusivity 
Date: Fri, December 10, 2004 9:13 am


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 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 

From: "Suliman Al-Fayoumi"
Subject: RE: [NMusers] pediatric PK studies for pediatric exclusivity 
Date: Fri, December 10, 2004 12:25 pm 

Hi Dolly;

Both traditional and Pop PK studies have been utilized in the past to 
generate PK data in pediatrics. However, the use of Pop PK in pediatrics has 
generally been encouraged by the FDA due to ethical and practical 
considerations. Prior to embarking on the study, you might want to discuss 
any proposed study designs with the respective Clinical Division within FDA. 
In addition, the current regulations mandate that studies intended for 
pediatric exclusivity may only enroll pediatric patients. I hope you find 
those comments helpful. Take care.

Suliman Al-Fayoumi
Clinical Pharmacology Reviewer