Drugs

Recommendations for Neonatal Pharmacology Guidance

IQVIA (formerly IMS Health and Quintiles) says an FDA draft guidance on general pharmacology considerations for neonatal studies for drugs and biological products provides a helpful explanation of the agency’s current thinking on the topic. The firm’s comment letter says it strongly advocates that generation of data in prenatal studies be done in accordance with a well-designed strategy that includes developing an innovative study design and clear strategic approach to application of modeling/simulation, statistical models, etc. IQVIA also suggests that the agency conduct a workshop with key stakeholders to better outline major study recommendations.

Takeda says that while the guidance is intended for both drugs and biologics, there is quite limited discussion from a biological products perspective. “Takeda recommends that additional considerations for biological products are warranted and that the guidance should be expanded accordingly throughout,” the company says.

AstraZeneca comments that the main challenge to extrapolating information from adults or older children is a lack of ontogeny information of critical organ and tissue and physiological parameters. While the guidance often uses the word “should,” the company says, lacking basic information will make the extrapolation very challenging. AZ suggests that FDA assemble a workforce to have a comprehensive literature search and review, identify information resources, and research gap. “These can be added to the guidance as an appendix,” it says.

Finally, Pfizer says it “supports the agency’s thoughtful approach to addressing general clinical pharmacology considerations in neonates. Our comments are intended to point out particular areas where more specific directions would make the guidance clearer and increase precision to allow for more efficient use of these considerations. In addition, we suggest some potential additions to the guidance to increase clarity.”

All four letters also include specific, line-by-line comments and recommendations.

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