Monday, March 30 2020, 13:53 pm
Clinical Pharmacology and Biopharmaceutics Review(s)

Clinical Pharmacology and Biopharmaceutics Review(s)

Clinical pharmacology recommendation for PK assessment in pediatric patients For reasons stated above, we agree that PK assessment in pediatric patients 4-11 years old should be optional, and we recommend that the PK assessment not be included in the PMR (post mai·keting requirement). Page 2of 2 Reference ID: 4025352