EANM guideline on the validation of analytical methods for radiopharmaceuticals.
Radioanalytical methods
Radiopharmaceuticals
Validation
Journal
EJNMMI radiopharmacy and chemistry
ISSN: 2365-421X
Titre abrégé: EJNMMI Radiopharm Chem
Pays: England
ID NLM: 101714628
Informations de publication
Date de publication:
12 Feb 2020
12 Feb 2020
Historique:
received:
11
09
2019
accepted:
19
12
2019
entrez:
14
2
2020
pubmed:
14
2
2020
medline:
14
2
2020
Statut:
epublish
Résumé
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. Recommedations for the validation of analytical methods which are specific for radiopharmaceutials are presented in this guideline, along with two practical examples. In order to comply with good manufacturing practice, analytical methods for radiopharmaceuticals for human use should be validated.
Sections du résumé
BACKGROUND
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
RESULTS
Recommedations for the validation of analytical methods which are specific for radiopharmaceutials are presented in this guideline, along with two practical examples.
CONCLUSIONS
CONCLUSIONS
In order to comply with good manufacturing practice, analytical methods for radiopharmaceuticals for human use should be validated.
Identifiants
pubmed: 32052212
doi: 10.1186/s41181-019-0086-z
pii: 10.1186/s41181-019-0086-z
pmc: PMC7016057
doi:
Types de publication
Journal Article
Langues
eng
Pagination
7Références
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