EANM guideline on the validation of analytical methods for radiopharmaceuticals.
- Gillings N Department of Clinical Physiology, Nuclear Medicine and PET, Copenhagen University Hospital Rigshospitalet, Blegdamsvej 9, DK-2100, Copenhagen, Denmark. ngil0001@regionh.dk.
- Todde S Tecnomed Foundation, University of Milano - Bicocca, Milan, Italy.
- Behe M Center for Radiopharmaceutical Sciences, Paul Scherrer Institute, Villigen, Switzerland.
- Decristoforo C Department of Nuclear Medicine, Medical University Innsbruck, Innsbruck, Austria.
- Elsinga P Department of Nuclear Medicine and Molecular Imaging, University Medical Center Groningen, Groningen, The Netherlands.
- Ferrari V MSD Animal Health, Walton, UK.
- Hjelstuen O Institute for Energy Technology (IFE), Kjeller, Norway.
- Peitl PK University Medical Centre Ljubljana, Ljubljana, Slovenia.
- Koziorowski J Independant consultant, Linköbing, Sweden.
- Laverman P Radboud University Medical Center Nijmegen, Nijmegen, The Netherlands.
- Mindt TL Ludwig Boltzmann Institute Applied Diagnostics, Vienna, Austria.
- Ocak M Department of Pharmaceutical Technology, Istanbul University, Istanbul, Turkey.
- Patt M Department for Nuclear Medicine, University Hospital Leipzig, Leipzig, Germany.
- 2020-02-14
Published in:
- EJNMMI radiopharmacy and chemistry. - 2020
English
BACKGROUND
To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published guidance documents on the requirements for such validation activities and these have been adopted by the European Medicines Agency, The U.S. Food and Drug Administration (FDA) and other regulatory bodies. These guidance documents do not, however, fully address all the specific tests required for the analysis of radiopharmaceuticals. This guideline attempts to rectify this shortcoming, by recommending approaches to validate such methods.
RESULTS
Recommedations for the validation of analytical methods which are specific for radiopharmaceutials are presented in this guideline, along with two practical examples.
CONCLUSIONS
In order to comply with good manufacturing practice, analytical methods for radiopharmaceuticals for human use should be validated.
To fulfil good manufacturing requirements, analytical methods for the analysis of pharmaceuticals for human and vetinary use must be validated. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has published guidance documents on the requirements for such validation activities and these have been adopted by the European Medicines Agency, The U.S. Food and Drug Administration (FDA) and other regulatory bodies. These guidance documents do not, however, fully address all the specific tests required for the analysis of radiopharmaceuticals. This guideline attempts to rectify this shortcoming, by recommending approaches to validate such methods.
RESULTS
Recommedations for the validation of analytical methods which are specific for radiopharmaceutials are presented in this guideline, along with two practical examples.
CONCLUSIONS
In order to comply with good manufacturing practice, analytical methods for radiopharmaceuticals for human use should be validated.
- Language
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- English
- Open access status
- gold
- Identifiers
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- DOI 10.1186/s41181-019-0086-z
- PMID 32052212
- Persistent URL
- https://sonar.ch/global/documents/77891
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