Covalidation strategies to accelerate analytical method transfer for breakthrough therapies
According to USP , "the transferring unit can involve the receiving unit in an interlaboratory covalidation, including them as a part of the validation team, and thereby obtaining data for the assessment of reproducibility" (3). [...]covalidation is the preferred mode of analytical technol...
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Veröffentlicht in: | Pharmaceutical Technology 2017-04, Vol.41 (4), p.38 |
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Hauptverfasser: | , , |
Format: | Magazinearticle |
Sprache: | eng |
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Online-Zugang: | Volltext |
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Zusammenfassung: | According to USP , "the transferring unit can involve the receiving unit in an interlaboratory covalidation, including them as a part of the validation team, and thereby obtaining data for the assessment of reproducibility" (3). [...]covalidation is the preferred mode of analytical technology transfer within BMS where early identification and engagement of the receiving site is required. |
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ISSN: | 1543-2521 2150-7376 |