Conference Report from the European Bioanalysis Forum Workshop: toward harmonized implementation of the ICH M10 guideline / Philip Timmerman, Matthew Barfield, Kyra Cowan, Luca Ferrari, Michaela Golob, Joanne Goodman, Morten Kall, Anna Laurén, Iain Love, Stuart McDougall, Robert Nelson, Gwenda Pynaert, Roland F Staack, Tom Verhaeghe, Steve White
In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed or still ambiguous regulatory expectations in the guideline, as identified in feedback from the pre-workshop surveys or during the workshop. The proposals from the workshop aim at stimulating and helping a harmonized implementation of the guideline, and using our community as a sounding board during and after implementation to highlight areas of misalignment and to create a platform for continued sharing with the regulatory authorities in an effort to contribute to industry and regulators developing similar interpretations on guideline expectations.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
Erscheinungsort nicht ermittelbar: 2023 |
| Enthalten in: |
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| Sprache: |
Englisch |
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| Beteiligte Personen: |
Timmerman, Philip [VerfasserIn] |
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| Links: |
FID Access [lizenzpflichtig] |
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| Themen: |
Conference report |
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| Umfang: |
1 Online-Ressource (5 p) |
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| doi: |
10.4155/bio-2022-0229 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
KFL011093226 |
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| 520 | |a In this report, the European Bioanalysis Forum shares the proposals for harmonized implementation of the ICH M10 guideline on bioanalytical method validation and study sample analysis from the ICH M10 workshop. The focus of the discussions was to understand new, changed or still ambiguous regulatory expectations in the guideline, as identified in feedback from the pre-workshop surveys or during the workshop. The proposals from the workshop aim at stimulating and helping a harmonized implementation of the guideline, and using our community as a sounding board during and after implementation to highlight areas of misalignment and to create a platform for continued sharing with the regulatory authorities in an effort to contribute to industry and regulators developing similar interpretations on guideline expectations | ||
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| 700 | 1 | |a Golob, Michaela |e verfasserin |4 aut | |
| 700 | 1 | |a Goodman, Joanne |e verfasserin |4 aut | |
| 700 | 1 | |a Kall, Morten |e verfasserin |4 aut | |
| 700 | 1 | |a Laurén, Anna |e verfasserin |4 aut | |
| 700 | 1 | |a Love, Iain |e verfasserin |4 aut | |
| 700 | 1 | |a McDougall, Stuart |e verfasserin |4 aut | |
| 700 | 1 | |a Nelson, Robert |e verfasserin |4 aut | |
| 700 | 1 | |a Pynaert, Gwenda |e verfasserin |4 aut | |
| 700 | 1 | |a Staack, Roland F |e verfasserin |4 aut | |
| 700 | 1 | |a Verhaeghe, Tom |e verfasserin |4 aut | |
| 700 | 1 | |a White, Steve |e verfasserin |4 aut | |
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