Quality by Design for Preclinical In Vitro Assay Development.
CRISPR
JMP
assay optimization
design of experiments
design space
screening
Journal
Pharmaceutical statistics
ISSN: 1539-1612
Titre abrégé: Pharm Stat
Pays: England
ID NLM: 101201192
Informations de publication
Date de publication:
24 Sep 2024
24 Sep 2024
Historique:
revised:
10
05
2024
received:
02
10
2023
accepted:
08
07
2024
medline:
25
9
2024
pubmed:
25
9
2024
entrez:
24
9
2024
Statut:
aheadofprint
Résumé
Quality by Design (QbD) is an approach to assay development to determine the design space, which is the range of assay variable settings that should result in satisfactory assay quality. Typically, QbD is applied in manufacturing, but it works just as well in the preclinical space. Through three examples, we illustrate the QbD approach with experimental design and associated data analysis to determine the design space for preclinical assays.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Informations de copyright
© 2024 AstraZeneca. Pharmaceutical Statistics published by John Wiley & Sons Ltd.
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