Scintigraphy

Gamma scintigraphy is a safe non-invasive method for determining the biodistribution of drug delivery systems under physiological conditions, providing critical data early in the clinical development process. The successful application of scintigraphy reliesupon direct or indirect radiolabelling of a selected component of the dosage form using a suitable gamma-emitting radioisotope such as Technetium-99m or Indium-111.

Depending upon the study objectives, protocols may include regional or whole body imaging using planar scintigraphy, or SPECT techniques. Following dosing, the deposition, residence, clearance and dispersion of the dosage form can be defined. The scintigraphic analysis can also be complimented with expertise in pharmacokinetic and pharmacodynamic evaluations, drug assay development and bioanalysis.Imaging is performed using a ‘state of the art’ dual head gamma camera, situated in a purpose-built scintigraphy suite located in a GMP and GCP accredited facility.

Clinical Capabilities

CSL has formally collaborated with Simbec-Orion for over 25 years to provide a unique single resource for high quality scintigraphy studies in human subjects. The alliance provides support for all aspects of the clinical trial process, including:

    • Study Design & Protocol Development
    • Project Management
    • Regulatory Support
    • Clinical Monitoring
    • Pharmacovigilance

    • Central Laboratory
    • Bioanalytical Laboratory
    • IMP Management
    • Biometrics
    • Medical & Technical Writing

Scintigraphy

Gamma scintigraphy is a safe non-invasive method for determining the biodistribution of drug delivery systems under physiological conditions, providing critical data early in the clinical development process.The successful application of scintigraphy reliesupon direct or indirect radiolabelling of a selected component of the dosage form using a suitable gamma-emitting radioisotope such as Technetium-99m or Indium-111.

Depending upon the study objectives, protocols may include regional or whole body imaging using planar scintigraphy, or SPECT techniques. Following dosing, the deposition, residence, clearance and dispersion of the dosage form can be defined. The scintigraphic analysis can also be complimented with expertise in pharmacokinetic and pharmacodynamic evaluations, drug assay development and bioanalysis. Imaging is performed using a ‘state of the art’ dual head gamma camera, situated in a purpose-built scintigraphy suite located in a GMP and GCP accredited facility.

Clinical Capabilities

In partnership with Simbec-Orion CSL undertakes all aspects of the clinical trial process, including:

    • Study Design & Protocol Development
    • Project Management
    • Regulatory Support
    • Clinical Monitoring
    • Pharmacovigilance
    • Central Laboratory
    • Bioanalytical Laboratory
    • IMP Management
    • Biometrics
    • Medical & Technical Writing