Reference Datasets for Studies in a Replicate Design Intended for Average Bioequivalence with Expanding Limits.
average bioequivalence with expanding limits
black box software validation
reference scaling
replicate designs
Journal
The AAPS journal
ISSN: 1550-7416
Titre abrégé: AAPS J
Pays: United States
ID NLM: 101223209
Informations de publication
Date de publication:
07 02 2020
07 02 2020
Historique:
received:
18
11
2019
accepted:
26
01
2020
entrez:
9
2
2020
pubmed:
9
2
2020
medline:
27
1
2021
Statut:
epublish
Résumé
In order to help companies qualify and validate the software used to evaluate bioequivalence trials in a replicate design intended for average bioequivalence with expanding limits, this work aims to define datasets with known results. This paper releases 30 reference datasets into the public domain along with proposed consensus results. A proposal is made for results that should be used as validation targets. The datasets were evaluated by seven different software packages according to methods proposed by the European Medicines Agency. For the estimation of CV
Identifiants
pubmed: 32034551
doi: 10.1208/s12248-020-0427-6
pii: 10.1208/s12248-020-0427-6
doi:
Types de publication
Comparative Study
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
44Références
AAPS J. 2014 Nov;16(6):1292-7
pubmed: 25212768
AAPS J. 2015 Mar;17(2):400-4
pubmed: 25488055
Pharm Stat. 2012 Jan-Feb;11(1):1-7
pubmed: 22162308
Biometrics. 1946 Dec;2(6):110-4
pubmed: 20287815
Biometrics. 1997 Sep;53(3):983-97
pubmed: 9333350
Clin Pharmacokinet. 2009;48(11):725-43
pubmed: 19817502
Stat Med. 2002 Mar 15;21(5):629-48
pubmed: 11870806
Biometrics. 1968 Mar;24(1):61-73
pubmed: 5642410