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Quality Control Aspects of Pharmaceutical Gamma Scintigraphy Studies

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.


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By Simon Warren PhD, Scintigraphy Research Manager and Glyn Taylor PhD, Director of Scintigraphy Services at Simbec Scintigraphics Ltd

 Dr Simon J Warren is the Scintigraphy Research Manager at Simbec Scintigraphics. He studied for a degree in Applied Biology at the University of Wales Institute of Science and Technology and a PhD in Pharmaceutical Science at the Welsh School of Pharmacy (WSP) in Cardiff. Dr Warren subsequently gained a postdoctoral research position within the Pulmonary Delivery Group at the WSP, investigating novel formulation approaches for pressurised metered dose inhalers. Since joining Scintigraphics in 1994 he has been primarily responsible for radiolabelling development and validation programmes for both oral and inhalation delivery systems. Dr Glyn Taylor is Director of Scintigraphy Services at Simbec Scintigraphics and a Senior Lecturer at the Welsh School of Pharmacy, Cardiff University. He graduated with a BSc in Pharmacy from Aston University and gained a PhD in Pharmacokinetics from Manchester University.

Dr Taylor began work at Cardiff University in 1980 and has since held positions in Clinical Pharmacology at Stanford University and at the University of California, San Francisco, School of Pharmacy. He has published more than 140 research articles in the areas of pharmacokinetics, biopharmaceutics and scintigraphy.

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Dr Simon J Warren
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Dr Glyn Taylor
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