CTD Section 2.7.2 (clinical pharmacology, pharmacokinetics (PK), pharmacodynamics (PD), and PK/PD) is an important part of regulatory submissions. It includes evaluation of the drug’s metabolism, effect of extrinsic factors (food-effect), effect of intrinsic factors (e.g., age, gender, ethnicity, body weight, renal and/or hepatic function, etc.), dose-response, exposure-response, and biomarker evaluation.
A client came to Nuventra asking for assistance writing Section 2.7.2 of an NDA. The client previously had a medical writer develop Section 2.7.2 for the submission but they were unable to position the data in a manner that best represented the PK/PD characteristics of the drug.
Nuventra applied our extensive experience in PK/PD, not only to summarize prior clinical pharmacology studies, but to also integrate traditional noncompartmental PK analysis and population PK analysis into Section 2.7.2 for a complete description of the drug.
Nuventra used pharmacokinetics to support the proposed dosing regimen in the NDA and also conducted additional PK modeling and population PK/PD analyses during the authoring of Section 2.7.2 to bolster the client’s argument around dose selection.
Take home message
While many companies look to medical writers to author regulatory documents, having pharmacokineticists at Nuventra summarize pharmacokinetic data in regulatory documents (IND, NDA, BLA, Investigator Brochure, FDA meeting briefing packet, etc.) is a better option because of our fundamental understanding of the science and knowledge of PK, PD, PK/PD, and all clinical pharmacology studies.