Comparison of Analytical Procedures in Method Transfer and Bridging Experiments.
accuracy
bias
intermediate precision
life cycle of an analytical procedure
method transfer
precision
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
20 07 2023
20 07 2023
Historique:
received:
10
04
2023
accepted:
09
06
2023
medline:
21
7
2023
pubmed:
20
7
2023
entrez:
19
7
2023
Statut:
epublish
Résumé
Comparison of two analytical procedures is the primary objective of a method transfer or when replacing an old procedure with a new one in a single lab. Guidance for comparing two analytical procedures is provided in USP <1010> based on separate tests for accuracy and precision. Determination of criteria is somewhat problematic for these comparisons because of the interdependence of accuracy and precision. In this paper, a total error approach is proposed that requires a single criterion based on an allowable out-of-specification (OOS) rate at the receiving lab. This approach overcomes the difficulty of allocating acceptance criteria between precision and bias. Computations can be performed with any simulation software. Numerical examples are provided for four experimental designs that are typical in a method transfer study. Finally, recommendations are provided to help the user set criteria that provide an acceptable probability of passing for practical sample sizes.
Identifiants
pubmed: 37468665
doi: 10.1208/s12248-023-00834-1
pii: 10.1208/s12248-023-00834-1
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
74Informations de copyright
© 2023. The Author(s), under exclusive licence to American Association of Pharmaceutical Scientists.
Références
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