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Scintigraphy is a widely used clinical diagnostic technique that has been utilised for pharmaceutical applications since the mid-1970s (1). Diagnostic procedures reflect the fact that nuclear medicine evaluations are based upon functional imaging and, in general, it is primarily the particular physiological process under investigation that governs the fate of the administered radiopharmaceutical. This article identifies key processes in the conduct of pharmaceutical gamma scintigraphy studies, and considers a standardised approach to quality control measures which would allow ready comparison and interpretation of data generated by different research groups.
Pharmaceutical scintigraphy may utilise the same technology as nuclear medicine, but the radiolabel is usually associated with a particular component of a pharmaceutical dosage form or delivery device in order that the efficacy and/or fate of the system can be assessed in vivo, such as in healthy volunteer or patient populations. In the majority of pharmaceutical scintigraphy studies, radiolabelling is achieved indirectly - for instance the label is incorporated into the formulation - but direct chemical/covalent labelling of drug molecules is not performed. As a consequence of this approach, in vitro characterisations must be performed in order to demonstrate effectively that the radiolabelling process has not modified the pharmaceutical properties of the dosage form, and that the label is associated with the desired component of the dosage form. |
