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 Natuli

link 16.11.2009 13:12 
Subject: stratum as factors and the pre-dose value corresponding to first dosing pharm.
Огромная просьба, поясните, пожалуйста, как перевести "stratum as factors and the pre-dose value corresponding to first dosing..." -
и о каком "overall mean ratio of the ratio vs. placebo" идет речь в последнем предложении - суммарное соотношение представляющее собой отношение чего к чему???

All PD and GHBP endpoints were analysed using descriptive statistics. Furthermore, the endpoints were analysed using an ANOVA model with dose level and stratum as factors and the pre-dose value corresponding to first dosing as a covariate. Endpoints (except iAUC0-168h and all SDS endpoints) and the corresponding pre-dose values were log-transformed. Mean ratios (differences for iAUC0-168h and SDS endpoints) between the doses of ХХХ and placebo were estimated and 95% CIs were calculated. Furthermore for each dose level, the hypothesis of no difference compared to placebo was tested. Steady state investigations of IGF-I and IGFBP-3 was done by estimating the mean ratios of the 168h post third and second dose concentration using an ANOVA model with the log-transformed ratio as dependent variable and dose as a factor. The mean ratios were estimated and 95% CIs were calculated. Furthermore, the overall mean ratio of the ratio vs. placebo was estimated using a similar ANOVA model with ХХХ/placebo as a factor with two levels only.

 Dimpassy

link 16.11.2009 13:19 
using an ANOVA model with dose level and stratum as factors and the pre-dose value corresponding to first dosing as a covariate - с использованием дисперсионного анализа, факторами которого являлись значение дозы и (ее? - ранее должно быть описание стратификации) страта, ковариатой - значение первой дозы.

 GhostLibrarian

link 16.11.2009 14:23 
pre-dose value - уверены?
значение чего-то до введения препарата (для первой дозы)

 Dimpassy

link 16.11.2009 15:43 
да, наверное так, надо по контексту сориентироваться

 Natuli

link 16.11.2009 16:04 
Спасибо за помощь.
Вот не понимаю о каком "pre-dose value" идет речь.
Еще если будет минутка гляньте, пожалуйста, последнее предложение "overall mean ratio of the ratio vs. placebo" тоже не могу понять о каком отношении написано..
совсем на всякий случай еще часть текста
PK endpoints included AUC, Cmax, tmax, t½, λz, Vz/f, CL/f, MRT derived from ХХХ plasma profiles. Further, in order to investigate steady state PK, the ratios of AUC0-168h after third dosing vs. AUC and AUC0-168h after first dosing, respectively, were calculated.
PD endpoints included AUC0-168h, incremental (baseline adjusted) AUC0-168h (iAUC0-168h), Cmax, and ∆Cmax (baseline adjusted) derived from IGF-1 and IGFBP-3 serum profiles. All endpoints were calculated in two versions using the measured concentrations (ng/mL) as well as age adjusted standard deviation scores (SDS). Further, the ratios between the 168h post third and second dose concentration were calculated.
The ∆Cmax, was defined as the ratio between Cmax and the corresponding baseline (i.e. pre-dose) value, whereas for SDS, it was the baseline subtracted Cmax. All AUC0-168h (and iAUC0-168h) were divided by 168h (the dosing interval) in order for these quantities to be interpreted as mean concentrations (for iAUC0-168h change in means) during the dosing interval.

 Dimpassy

link 16.11.2009 16:19 
pre-dose value corresponding to first dosing - значение параметра перед первым введением препарата

 Natuli

link 16.11.2009 20:50 
Dimpassy спасибо!

 

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