FDA Issues Draft Guidance on Pharmacology Considerations for Neonatal Studies

Researchers should use innovative approaches and all information available when designing a neonatal study, as neonates come with serious considerations, such as a limited amount of circulating blood and rapid and varying rates of maturation, the agency advises in draft guidance.

The guidance, which complements the FDA’s 2014 draft guidance on pediatric study considerations, aims to help drug and biologics sponsors conduct and develop studies of neonatal populations, offering suggestions on general clinical pharmacology matters to keep in mind.

For example, conventional pharmacokinetic studies that use intensive blood sampling can rarely be used in neonate studies due to their limited circulating blood volume.