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Say no to guesswork.
Get definitive answers.
Prove product claims.
Visualize formulation behavior in man.
Site of disintegration
Time of disintegration
in vitro-in vivo correlation
Inter and intra subject variability
Gamma scintigraphy is a powerful and versatile technology used to investigate the in-vivo performance of your drug or product. This non-invasive imaging technique allows us to follow the fate of the dosage form and administering it to a volunteer or patient. Not limited to just oral dosage forms, gamma scintigraphy can be used to image formulation behaviour in the lungs, eyes, nose, oesophagus or any other site of administration of your product. PK analysis can be coupled with scintigraphy to give a complete picture of your products behaviour. We are market leaders in gamma scintigraphy with a proven track record and a global client base.
World Class Leading Site
As a GMP-licensed manufacturing site, we will handle your Investigational Medicinal Product expertly to ensure regulatory compliance and the highest quality of data. We provide QP release, and our registered pharmacists will dispense the final IMP for clinical administration. Our ISO 9001 accredited clinical services division boasts a gamma camera suite, wards for when overnight trials are required and a GMP manufacturing suite. Our clinical facilities are regularly inspected by the MHRA and client auditors and all clinical work is fully ICH GCP-compliant. The clinical team are co-located with and work closely with the innovations lab to share expertise and knowledge which is brought to every client project to ensure that what we deliver goes beyond your expectations.
Show definitively that your product works faster, better or longer than that of your competitors
Scintigraphy is a powerful, fast and incredibly effective tool providing a much clearer picture than PK data alone offers. The information that you get on the in vivo performance of your formulation combined with our expertise allows you to shape your formulation development strategy, reducing costs and time to market. Scintigraphic data can also be used to support drug delivery claims, for marketing or regulatory purposes.
BDD undertakes all aspects of the clinical trial process, including:
• Protocol design
• Ethical and regulatory approval processes
• Clinical trial document design
• Volunteer/patient recruitment and screening
• GMP manufacture of radiolabelled IMP
• PK sampling
• Trial management and monitoring
• Data management and analysis
• Production of GCP-compliant clinical study report
Our ward facilities accommodate overnight patient stays, if required for monitoring or to ensure compliance with study lifestyle or dietary restrictions. We carry out blood sample collection, processing and storage. Our GCP-trained locum medics provide medical cover for all trials and we work closely with hospital physicians, who we routinely appoint as principal investigators. We are regularly inspected by the MHRA and client auditors and all clinical work is fully ICH GCP-compliant.