Randomized response surface pathway design with skewed starting point and stochastic dose window

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dc.contributor.authorTrond, Holanden_US
dc.contributor.authorØystein, Evensenen_US
dc.contributor.authorDewi, Sagitaen_US
dc.contributor.authorLarsen, Stigen_US
dc.date.accessioned2020-05-06T08:34:23Z
dc.date.available2020-05-06T08:34:23Z
dc.date.issued2020-01
dc.description.abstractBackground:The aim was to introduce response surface pathway(RSP)-design with skewed starting value and stochastic dose-window to estimate optimal efficacy dose (OED) of BP-C2 after IL-1? stimulation in Atlantic salmon.Methods:54 healthy smolt of Atlantic salmon between 50 and 100g before habituated to saltwater were included. The study was conducted as a one-dimensional, randomized between-patient three-level RSP designed trial with one interventional-and one response variable and odd outcomes. The interventional variable was intraperitoneal injected BPC2 with skewed starting dose of 0.10 mg/100g related to the initial dose-window <0.02-0.5 mg/100g. The response variable was the Ct-value of mRNA IL-1? expression 24 hours after injection.Results:Skewed starting value of 0.10 mg/100g was chosen in the first design-level with a dose-window of <0.0-0.20].The three smolt obtained a reduction in Ct-value above 15%, and the dose-window adjusted with the lower boundary equals the previous dose. The five smolt at second esign-level received 0.16 mg/100g with a dose-window [0.10-0.22]. Four smolt obtained above 15% and one of 0.5% reduction in cycle threshold (Ct)-value. Six smolt in the third design-level received 0.21 mg/100g and one 0.16 mg/100g. The mean Ct-value was reduced from 30.0 in the nstimulated situation to 25.0, 24.8 and 26.4 after BP-C2 stimulation of 0.10, 0.16 and 0.21mg/100g, respectively. The OED of BP-C2 related to IL-1? was estimated to 0.14 mg/100g.Conclusions: Skewed starting value in the initial dose-window made the K-adjustment factor and dose-window stochastic. The RSP-procedure works in accordance to the expectation and estimated OED of BP-C2 sufficiently.en_US
dc.identifier.affiliationsDepartment of Production Animal Clinical Sciences, Norwegian University of Life Science, Faculty of Veterinary Medicine, Oslo, Norwayen_US
dc.identifier.affiliationsBali Indera Hospital, Government of Bali Province, Indonesiaen_US
dc.identifier.citationTrond Holand, Øystein Evensen, Dewi Sagita, Larsen Stig . Randomized response surface pathway design with skewed starting point and stochastic dose window. International Journal of Clinical Trials. 2020 Jan; 7(1): 18-27en_US
dc.identifier.issn2349-3240
dc.identifier.issn2349-3259
dc.identifier.placeIndiaen_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/200960
dc.languageenen_US
dc.publisherMedip Academyen_US
dc.relation.issuenumber1en_US
dc.relation.volume7en_US
dc.source.urihttps://dx.doi.org/10.18203/2349-3259.ijct20200202en_US
dc.subjectResponse surface pathway designen_US
dc.subjectSkewed starting valueen_US
dc.subjectStochastic dose - windowen_US
dc.subjectIL -1? mRNA expressionen_US
dc.subjectBP-C2en_US
dc.subjectSalmonen_US
dc.titleRandomized response surface pathway design with skewed starting point and stochastic dose windowen_US
dc.typeJournal Articleen_US
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