Matches in SemOpenAlex for { <https://semopenalex.org/work/W2991547990> ?p ?o ?g. }
Showing items 1 to 79 of
79
with 100 items per page.
- W2991547990 endingPage "242" @default.
- W2991547990 startingPage "230" @default.
- W2991547990 abstract "Summary 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." @default.
- W2991547990 created "2019-12-05" @default.
- W2991547990 creator A5006196582 @default.
- W2991547990 creator A5019871681 @default.
- W2991547990 creator A5020601958 @default.
- W2991547990 creator A5032118390 @default.
- W2991547990 creator A5047551256 @default.
- W2991547990 date "2019-11-24" @default.
- W2991547990 modified "2023-09-26" @default.
- W2991547990 title "Comparisons of outlier tests for potency bioassays" @default.
- W2991547990 cites W1833314573 @default.
- W2991547990 cites W1966177288 @default.
- W2991547990 cites W1970101888 @default.
- W2991547990 cites W2027596934 @default.
- W2991547990 cites W2029437336 @default.
- W2991547990 cites W2060500979 @default.
- W2991547990 cites W2110065044 @default.
- W2991547990 cites W2135477962 @default.
- W2991547990 cites W2281269228 @default.
- W2991547990 cites W2328056838 @default.
- W2991547990 cites W2489822048 @default.
- W2991547990 cites W2887618219 @default.
- W2991547990 cites W2077487293 @default.
- W2991547990 doi "https://doi.org/10.1002/pst.1984" @default.
- W2991547990 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/31762118" @default.
- W2991547990 hasPublicationYear "2019" @default.
- W2991547990 type Work @default.
- W2991547990 sameAs 2991547990 @default.
- W2991547990 citedByCount "3" @default.
- W2991547990 countsByYear W29915479902020 @default.
- W2991547990 countsByYear W29915479902021 @default.
- W2991547990 countsByYear W29915479902023 @default.
- W2991547990 crossrefType "journal-article" @default.
- W2991547990 hasAuthorship W2991547990A5006196582 @default.
- W2991547990 hasAuthorship W2991547990A5019871681 @default.
- W2991547990 hasAuthorship W2991547990A5020601958 @default.
- W2991547990 hasAuthorship W2991547990A5032118390 @default.
- W2991547990 hasAuthorship W2991547990A5047551256 @default.
- W2991547990 hasConcept C104488531 @default.
- W2991547990 hasConcept C105795698 @default.
- W2991547990 hasConcept C202751555 @default.
- W2991547990 hasConcept C33923547 @default.
- W2991547990 hasConcept C41008148 @default.
- W2991547990 hasConcept C54355233 @default.
- W2991547990 hasConcept C55493867 @default.
- W2991547990 hasConcept C57992300 @default.
- W2991547990 hasConcept C79337645 @default.
- W2991547990 hasConcept C86803240 @default.
- W2991547990 hasConceptScore W2991547990C104488531 @default.
- W2991547990 hasConceptScore W2991547990C105795698 @default.
- W2991547990 hasConceptScore W2991547990C202751555 @default.
- W2991547990 hasConceptScore W2991547990C33923547 @default.
- W2991547990 hasConceptScore W2991547990C41008148 @default.
- W2991547990 hasConceptScore W2991547990C54355233 @default.
- W2991547990 hasConceptScore W2991547990C55493867 @default.
- W2991547990 hasConceptScore W2991547990C57992300 @default.
- W2991547990 hasConceptScore W2991547990C79337645 @default.
- W2991547990 hasConceptScore W2991547990C86803240 @default.
- W2991547990 hasIssue "3" @default.
- W2991547990 hasLocation W29915479901 @default.
- W2991547990 hasOpenAccess W2991547990 @default.
- W2991547990 hasPrimaryLocation W29915479901 @default.
- W2991547990 hasRelatedWork W1997661116 @default.
- W2991547990 hasRelatedWork W2022638109 @default.
- W2991547990 hasRelatedWork W2030514041 @default.
- W2991547990 hasRelatedWork W2068050824 @default.
- W2991547990 hasRelatedWork W2075531185 @default.
- W2991547990 hasRelatedWork W2094875408 @default.
- W2991547990 hasRelatedWork W2128288895 @default.
- W2991547990 hasRelatedWork W2369937030 @default.
- W2991547990 hasRelatedWork W2402311171 @default.
- W2991547990 hasRelatedWork W4232026532 @default.
- W2991547990 hasVolume "19" @default.
- W2991547990 isParatext "false" @default.
- W2991547990 isRetracted "false" @default.
- W2991547990 magId "2991547990" @default.
- W2991547990 workType "article" @default.