Comparisons of outlier tests for potency bioassays.
ROUT
USP
bioassay
outlier
potency
Journal
Pharmaceutical statistics
ISSN: 1539-1612
Titre abrégé: Pharm Stat
Pays: England
ID NLM: 101201192
Informations de publication
Date de publication:
05 2020
05 2020
Historique:
received:
11
02
2019
revised:
16
07
2019
accepted:
15
10
2019
pubmed:
26
11
2019
medline:
22
4
2021
entrez:
26
11
2019
Statut:
ppublish
Résumé
Potency bioassays are used to measure biological activity. Consequently, potency is considered a critical quality attribute in manufacturing. Relative potency is measured by comparing the concentration-response curves of a manufactured test batch with that of a reference standard. If the curve shapes are deemed similar, the test batch is said to exhibit constant relative potency with the reference standard, a critical requirement for calibrating the potency of the final drug product. Outliers in bioassay potency data may result in the false acceptance/rejection of a bad/good sample and, if accepted, may yield a biased relative potency estimate. To avoid these issues, the USP<1032> recommends the screening of bioassay data for outliers prior to performing a relative potency analysis. In a recently published work, the effects of one or more outliers, outlier size, and outlier type on similarity testing and estimation of relative potency were thoroughly examined, confirming the USP<1032> outlier guidance. As a follow-up, several outlier detection methods, including those proposed by the USP<1010>, are evaluated and compared in this work through computer simulation. Two novel outlier detection methods are also proposed. The effects of outlier removal on similarity testing and estimation of relative potency were evaluated, resulting in recommendations for best practice.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
230-242Informations de copyright
© 2019 John Wiley & Sons, Ltd.
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