Nuventra Services Provided for Bioavailability and Bioequivalence Studies
- Strategic planning to determine if a Bioavailability study or Bioequivalence trial should be conducted
Full clinical protocol development from clinical pharmacology experts
- Bioavailability study design and Bioequivalence study design
- Power calculation for determination sample size for BE study
- PK sampling schedule evaluation
- Topline assessment of food effect within 24 hours
- Full PK analysis (PK parameters) conducted in WinNonlin
- Full or abbreviated PK report
- Clinical study reports (CSRs) – with integrated PK data
- Investigator Brochure (IB) updates to clinical pharmacology and PK data
- FDA meetings or EMA meetings: Expert clinical pharmacology representation at regulatory meetings (including Briefing packet preparation)
- Interpretation of PK data to enable next steps in the development program
- Incorporation of data into model based drug development to allow for better decision making.
- Impact of study results on other planned clinical studies
- Although Nuventra does not enroll or dose subjects in clinical trials, our high level of experience with designing, executing and analyzing data from clinical pharmacology & PK/PD studies makes us the best option for clients needing advice in this area of drug development.
Brief Scientific & PK Considerations for BA and BE Studies
BE study versus a BA study: In general BE studies are more expensive due to a larger number of subjects needed for sufficient power to establish bioequivalence. However, in several instances, Nuventra has been able to assist clients with avoiding a fully powered BE study in favor of a less intensive and more cost effective BA study. We have interacted with the FDA on multiple occasions to argue that a BA study could be sufficient for the needs of a specific drug development program versus a formally powered and much larger BE study. This approach certainly doesn’t work in all instances but could be an option for your program depending on the intended need for such studies and data.
For more information or assistance please Contact us or request a quote.
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Contact us or request a quote to help interpret the guidance to industry and with your drug development needs for this type of clinical pharmacology investigation.