Gamma scintigraphy is a non-invasive imaging technique that can significantly reduce risk in clinical studies by providing direct, quantitative evidence of how a drug product behaves in the body in healthy volunteers or patient populations.

Key Ways It Derisks Clinical Studies
Confirms In Vivo Drug Delivery: Gamma scintigraphy visually and quantitatively confirms that the drug reaches its intended site (e.g., lungs, GI tract, nasal cavity) under real clinical conditions. This helps ensure that the formulation and device perform as expected in humans, reducing uncertainty before larger trials.

Explains Unexpected Outcomes: If early clinical data are unexpected (e.g., lower efficacy, unusual absorption), scintigraphy can reveal whether the issue is due to poor delivery or distribution, helping to avoid costly late-stage failures.

Supports Dose Selection and Study Design: By mapping how much drug is delivered and where, researchers can optimize dosing strategies and refine inclusion criteria, improving study design and reducing the risk of inconclusive results.

Combines with PK Data for Deeper Insight: When paired with pharmacokinetic (PK) data (“pharmacoscintigraphy”), scintigraphy helps correlate drug location and movement with blood levels, clarifying the reasons for variability and supporting rational decision-making.

Facilitates Regulatory Confidence: The robust, visual data generated by gamma scintigraphy can support regulatory submissions and provide early evidence that de-risks further investment in clinical development.

In Summary: Gamma scintigraphy helps derisk clinical studies by confirming drug delivery in vivo, explaining unexpected results, optimizing study design, and providing strong evidence to support regulatory and development decisions.