This series of blog posts describes some of the benefits of partnering with Nuventra to meet your PK/PD needs in drug development.
Planning for, and Reviewing, Section 2.7.2 of an NDA (Clinical Pharmacology and PK data)
- While conducting their pivotal Phase 3 study, a client came to Nuventra and asked for assistance with reviewing Section 2.7.2 of their upcoming NDA.
- Nuventra conducted a gap analysis on all clinical pharmacology studies and PK/PD analyses conducted for the client’s compound and concluded that multiple gaps existed that needed to be addressed prior to NDA filing.
- Nuventra proposed a plan to address these gaps by evaluating PK data from their pivotal Phase 3 program (population PK), and re-analyzing prior PK studies to produce fully compliant PK/PD reports for submission.
- Nuventra then recommended strategies for authoring Section 2.7.2 to best present all PK/PD data with the most scientifically sound arguments.
Take home message
While most companies look to medical writers to author regulatory documents, having Pharmacokineticists summarize pharmacokinetic data in regulatory documents (INDs, NDAs, Investigator Brochures, briefing packets, etc.) is a smarter way because of their fundamental understanding of the science and ability to best represent the PK/PD data to regulatory agencies.
Click here to speak with Nuventra and start doing it smarter today.