Proof of Hazard and Proof of Safety in Toxicological Studies Using Simultaneous Confidence Intervals for Differences and Ratios to Control

Simultaneous confidence interval for differences or ratios to control are described for both the proof of hazard and the proof of safety for the typical design in toxicology including several doses and a control. For most endpoints the direction of harmfulness is a priori known; therefore one-sided confidence intervals for Gaussian distributed endpoints, proportions, and poly-k-adjusted tumor rates are used. Special packages in the software R are provided to estimate these confidence intervals. Real data examples are given to demonstrate the estimation of the confidence intervals and their interpretation for selected toxicological studies.     

Untersuchungen zur Reaktion von fetalem Fibrinogen mit Reptilase

Zusammenfassung Die bei fetalem Fibrinogen charakteristisch verlängerte Umwandlungszeit zu Fibrin bei alkalischen pH-Werten kann nur beobachtet werden, wenn fetales Fibrinogen mit Thrombin zur Gerinnung gebracht wird. Mit Reptilase anstelle von Thrombin findet man keine Unterschiede zwischen adultem und fetalem Fibrinogen.Es wird vermutet, daß die molekularen Besonderheiten des fetalen Fibrinogens in der (B)-Kette festgelegt sind, da durch Reptilase im Gegensatz zu Thrombin keine Peptid-Abspaltung von der (B)-Kette des Fibrinogens erfolgt.Die Arbeit wurde unterstützt durch Mittel der Deutschen Forschungsgemeinschaft, Bonn-Bad Godesberg, über den Sonderforschungsbereich 46 Molekulare Grundlagen der Entwicklung, Feiburg i.Br.     

Shifts Toward Morningness During Behavioral Sleep Interventions Are Associated With Improvements in Depression,Positive Affect,and Sleep Quality

Morningness-eveningness (M-E) is typically considered to be a trait-like construct. However, M-E could plausibly shift in concert with changes in circadian or homeostatic processes. We examined M-E changes across three studies employing behavioral or pharmacological sleep treatments. Baseline and posttreatment M-E scores were strongly correlated across all three samples. M-E showed small but systematic changes toward morningness in sleep-disturbed military veterans receiving behavioral interventions. No systematic M-E changes were observed in the two pharmacological studies (sleep-disturbed military veterans and adults with primary insomnia, respectively). In the behavioral study, M-E changes correlated with changes in depression, positive affect, and sleep quality. M-E changes also correlated with changes in positive affect in the adult insomnia group. M-E appears to exhibit state-like aspects in addition to trait-like aspects.