Overview of Site of Absorption Studies
Site of absorption studies are conducted early in development with different formulations of a given drug to determine which has the highest absorption at distinct locations of the GI track (jejunum, ilium, colon) or which formulation releases drug at the optimal location in the GI track for maximum absorption and bioavailability.
Nuventra Services Provided for these Types of Studies
- Full clinical protocol development from clinical pharmacology experts
- Clinical trial design
- PK sampling schedule evaluation
- Ensure the collection of blood and other samples occur at the right time to allow a good assessment of pharmacokinetics
- 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
Brief Scientific & PK Considerations for these Studies
Site of absorption studies rely on pharmacokinetics following release of drug at specific locations of the GI track. The PK parameters determined from release in areas of the small intestine (jejunum, ilium) or large intestine (colon) are compared and used to evaluate the optimal formulation for additional clinical trials.
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When to Execute Site of Absorption Studies in Development Programs
The timing around execution of a site of absorption study depends on multiple factors including interactions with regulatory authorities, funding, investor expectations, exit strategies, and overall clinical development plans to support future studies or de-risk the continued development of a drug.
Let Nuventra’s clinical pharmacology consultants, pharmacokineticists, and drug development experts help intelligently integrate this study into your overall development efforts. Click here for a Clinical Pharmacology Plan.
Contact us or request a quote to help with your drug development needs for this type of clinical pharmacology investigation.