Randomized response surface pathway design with skewed starting point and stochastic dose window
Background: 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-1β stimulation in Atlantic salmon.Methods: 54 healthy smolt of Atlantic salmon between 50 and 100 g before habitu...
Published in: | International Journal of Clinical Trials |
---|---|
Main Authors: | , , , |
Other Authors: | |
Format: | Article in Journal/Newspaper |
Language: | English |
Published: |
Medip Academy
2020
|
Subjects: | |
Online Access: | https://www.ijclinicaltrials.com/index.php/ijct/article/view/365 https://doi.org/10.18203/2349-3259.ijct20200202 |
id |
ftjijctrials:oai:ojs.ijclinicaltrials.com:article/365 |
---|---|
record_format |
openpolar |
spelling |
ftjijctrials:oai:ojs.ijclinicaltrials.com:article/365 2023-05-15T15:32:58+02:00 Randomized response surface pathway design with skewed starting point and stochastic dose window Holand, Trond Evensen, Øystein Dewi, Sagita Larsen, Stig Norwegian University of Life Sciences 2020-01-24 application/pdf https://www.ijclinicaltrials.com/index.php/ijct/article/view/365 https://doi.org/10.18203/2349-3259.ijct20200202 eng eng Medip Academy https://www.ijclinicaltrials.com/index.php/ijct/article/view/365/211 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/550 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/551 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/552 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/553 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/554 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/555 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/556 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/557 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/558 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/559 https://www.ijclinicaltrials.com/index.php/ijct/article/view/365 doi:10.18203/2349-3259.ijct20200202 Copyright (c) 2020 International Journal of Clinical Trials International Journal of Clinical Trials; Vol 7, No 1 (2020): January-March 2020; 18-27 2349-3259 2349-3240 Response surface pathway design Skewed starting value Stochastic dose-window IL-1β mRNA expression BP-C2 Salmon info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion 2020 ftjijctrials https://doi.org/10.18203/2349-3259.ijct20200202 2022-08-21T15:12:27Z Background: 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-1β stimulation in Atlantic salmon.Methods: 54 healthy smolt of Atlantic salmon between 50 and 100 g before habituated to salt water 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/100 g related to the initial dose-window <0.02-0.5 mg/100 g. The response variable was the Ct-value of mRNA IL-1β expression 24 hours after injection.Results: Skewed starting value of 0.10 mg/100 g 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 design-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/100 g and one 0.16 mg/100 g. The mean Ct-value was reduced from 30.0 in the unstimulated situation to 25.0, 24.8 and 26.4 after BP-C2 stimulation of 0.10, 0.16 and 0.21 mg/100 g, respectively. The OED of BP-C2 related to IL-1β was estimated to 0.14 mg/100 g.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. Article in Journal/Newspaper Atlantic salmon International Journal of Clinical Trials (IJCT) International Journal of Clinical Trials 7 1 18 |
institution |
Open Polar |
collection |
International Journal of Clinical Trials (IJCT) |
op_collection_id |
ftjijctrials |
language |
English |
topic |
Response surface pathway design Skewed starting value Stochastic dose-window IL-1β mRNA expression BP-C2 Salmon |
spellingShingle |
Response surface pathway design Skewed starting value Stochastic dose-window IL-1β mRNA expression BP-C2 Salmon Holand, Trond Evensen, Øystein Dewi, Sagita Larsen, Stig Randomized response surface pathway design with skewed starting point and stochastic dose window |
topic_facet |
Response surface pathway design Skewed starting value Stochastic dose-window IL-1β mRNA expression BP-C2 Salmon |
description |
Background: 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-1β stimulation in Atlantic salmon.Methods: 54 healthy smolt of Atlantic salmon between 50 and 100 g before habituated to salt water 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/100 g related to the initial dose-window <0.02-0.5 mg/100 g. The response variable was the Ct-value of mRNA IL-1β expression 24 hours after injection.Results: Skewed starting value of 0.10 mg/100 g 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 design-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/100 g and one 0.16 mg/100 g. The mean Ct-value was reduced from 30.0 in the unstimulated situation to 25.0, 24.8 and 26.4 after BP-C2 stimulation of 0.10, 0.16 and 0.21 mg/100 g, respectively. The OED of BP-C2 related to IL-1β was estimated to 0.14 mg/100 g.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. |
author2 |
Norwegian University of Life Sciences |
format |
Article in Journal/Newspaper |
author |
Holand, Trond Evensen, Øystein Dewi, Sagita Larsen, Stig |
author_facet |
Holand, Trond Evensen, Øystein Dewi, Sagita Larsen, Stig |
author_sort |
Holand, Trond |
title |
Randomized response surface pathway design with skewed starting point and stochastic dose window |
title_short |
Randomized response surface pathway design with skewed starting point and stochastic dose window |
title_full |
Randomized response surface pathway design with skewed starting point and stochastic dose window |
title_fullStr |
Randomized response surface pathway design with skewed starting point and stochastic dose window |
title_full_unstemmed |
Randomized response surface pathway design with skewed starting point and stochastic dose window |
title_sort |
randomized response surface pathway design with skewed starting point and stochastic dose window |
publisher |
Medip Academy |
publishDate |
2020 |
url |
https://www.ijclinicaltrials.com/index.php/ijct/article/view/365 https://doi.org/10.18203/2349-3259.ijct20200202 |
genre |
Atlantic salmon |
genre_facet |
Atlantic salmon |
op_source |
International Journal of Clinical Trials; Vol 7, No 1 (2020): January-March 2020; 18-27 2349-3259 2349-3240 |
op_relation |
https://www.ijclinicaltrials.com/index.php/ijct/article/view/365/211 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/550 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/551 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/552 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/553 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/554 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/555 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/556 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/557 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/558 https://www.ijclinicaltrials.com/index.php/ijct/article/downloadSuppFile/365/559 https://www.ijclinicaltrials.com/index.php/ijct/article/view/365 doi:10.18203/2349-3259.ijct20200202 |
op_rights |
Copyright (c) 2020 International Journal of Clinical Trials |
op_doi |
https://doi.org/10.18203/2349-3259.ijct20200202 |
container_title |
International Journal of Clinical Trials |
container_volume |
7 |
container_issue |
1 |
container_start_page |
18 |
_version_ |
1766363445834285056 |