RE: pediatric PK studies for pediatric exclusivity

From: "Suliman Al-Fayoumi" alfayoumi@hotmail.com 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 CDER/FDA _______________________________________________________