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.
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
