| Title |
EANM guideline on the validation of analytical methods for radiopharmaceuticals
|
|---|---|
| Published in |
EJNMMI Radiopharmacy and Chemistry, February 2020
|
| DOI | 10.1186/s41181-019-0086-z |
| Pubmed ID | |
| Authors |
Nic Gillings, Sergio Todde, Martin Behe, Clemens Decristoforo, Philip Elsinga, Valentina Ferrari, Olaug Hjelstuen, Petra Kolenc Peitl, Jacek Koziorowski, Peter Laverman, Thomas L. Mindt, Meltem Ocak, Marianne Patt |
| Abstract |
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. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 135 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 135 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 20 | 15% |
| Student > Master | 15 | 11% |
| Student > Bachelor | 10 | 7% |
| Other | 10 | 7% |
| Student > Ph. D. Student | 9 | 7% |
| Other | 12 | 9% |
| Unknown | 59 | 44% |
| Readers by discipline | Count | As % |
|---|---|---|
| Chemistry | 20 | 15% |
| Pharmacology, Toxicology and Pharmaceutical Science | 16 | 12% |
| Medicine and Dentistry | 13 | 10% |
| Biochemistry, Genetics and Molecular Biology | 4 | 3% |
| Chemical Engineering | 4 | 3% |
| Other | 12 | 9% |
| Unknown | 66 | 49% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 19 January 2021.
All research outputs
#18,717,206
of 23,199,478 outputs
Outputs from EJNMMI Radiopharmacy and Chemistry
#68
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Outputs of similar age
#334,357
of 456,505 outputs
Outputs of similar age from EJNMMI Radiopharmacy and Chemistry
#4
of 5 outputs
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