scholarly journals Bayesian leveraging of historical control data for a clinical trial with time‐to‐event endpoint

2020 ◽  
Vol 39 (7) ◽  
pp. 984-995
Author(s):  
Satrajit Roychoudhury ◽  
Beat Neuenschwander
Keyword(s):  
Clinical Trial ◽  
Historical Control ◽  
Time To Event ◽  
Control Data ◽  
Historical Control Data

Historical control data on developmental toxicity studies in rodents

2014 ◽  
Vol 54 (3) ◽  
pp. 150-161 ◽  
Author(s):  
Makoto Ema ◽  
Katsumi Endoh ◽  
Ryou Fukushima ◽  
Sakiko Fujii ◽  
Hiroaki Hara ◽  
...  
Keyword(s):  
Developmental Toxicity ◽  
Historical Control ◽  
Control Data ◽  
Toxicity Studies ◽  
Historical Control Data

scholarly journals HISTORICAL CONTROL DATA OF SPONTANEOUS LESIONS IN BEAGLE DOGS.

1994 ◽  
Vol 7 (3) ◽  
pp. 329-343 ◽  
Author(s):  
Kazuo Kobayashi ◽  
Yasuhiko Hirouchi ◽  
Hijiri Iwata ◽  
Seiki Yamakawa ◽  
Shin-ichi Mikami ◽  
...  
Keyword(s):  
Historical Control ◽  
Beagle Dogs ◽  
Control Data ◽  
Historical Control Data

Compilation and use of genetic toxicity historical control data

2011 ◽  
Vol 723 (2) ◽  
pp. 87-90 ◽  
Author(s):  
Makoto Hayashi ◽  
Kerry Dearfield ◽  
Peter Kasper ◽  
David Lovell ◽  
Hans-Joerg Martus ◽  
...  
Keyword(s):  
Historical Control ◽  
Control Data ◽  
Genetic Toxicity ◽  
Historical Control Data

scholarly journals Historical control data for hematology parameters obtained from toxicity studies performed on different Wistar rat strains: Acceptable value ranges, definition of severity degrees, and vehicle effects

2020 ◽  
Vol 4 ◽  
pp. 239784732093148
Author(s):  
Marlies de Kort ◽  
Klaus Weber ◽  
Björn Wimmer ◽  
Katharina Wilutzky ◽  
Patricia Neuenhahn ◽  
...  
Keyword(s):  
Health Status ◽  
Strain Differences ◽  
Wistar Rat ◽  
Historical Control ◽  
Data Sets ◽  
Rat Strains ◽  
Control Data ◽  
Data Set ◽  
Hematology Parameters ◽  
Historical Control Data

The physiological and health status of control animals may vary. Due to this variation, it is important to define acceptable ranges of control hematology parameters to gain a better understanding of adverse and non-adverse effects of test substances. After generating historical control data for two Wistar rat strains (RccHan™:WIST and Crl:WI(Han)) from different breeders, the data sets were statistically analyzed using Minitab®. After noticing that single outliers can affect the study control data set, the respective outliers were verified relative to the available histopathology findings, for example, inflammatory pulmonary lesions following vehicle aspiration or spontaneous sperm granuloma affecting the health status and hematology data of the respective animals. Such data points were excluded from the control data set. Comparing both data sets, it was obvious that different blood sampling and anesthesia methods as well as strain differences may result in slightly different values. After excluding the outliers, a data set from animals with presumably good health status was generated to define acceptable ranges and severity degrees. To evaluate effects, possibly influencing hematology parameters and defined acceptable ranges, selected vehicles and different study types were observed.

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