Assessment of dermal absorption of aluminium from a representative antiperspirant formulation using a ( 26 Al)Al microtracer approach: a follow-up study in humans

A follow-up study was performed in 12 healthy women to evaluate systemic exposure to aluminium following topical application of a representative antiperspirant formulation under real-life use conditions (part A) and to assess the local fate of topically applied aluminium by taking additional tape strips and skin biopsies (Part B). A simple roll...

What employees do today because of their experience yesterday: Previous exposure to yellow:number aspects as a cause for SPAD incidents

When a train passes a red aspect, this is called a Signal Passed at Danger event or SPAD. Sometimes it is easy to identify the SPAD cause but in other cases it is unclear why the incident occurred, especially if the system operated as usual and the train driver was trained and experienced just like his or her colleagues. In previous research,...

How cognitive biases influence the data verification of safety indicators: A case study in rail

The field of safety and incident prevention is becoming more and more data based. Data can help support decision making for a more productive and safer work environment, but only if the data can be, is and should be trusted. Especially with the advance of more data collection of varying quality, checking and judging the data is an increasingly...

Assessment of Dermal Absorption of Aluminum from a Representative Antiperspirant Formulation Using a 26 Al Microtracer Approach

A clinical pharmacokinetic study was performed in 12 healthy women to evaluate systemic exposure to aluminum following topical application of a representative antiperspirant formulation under real-life use conditions. A simple roll-on formulation containing an extremely rare isotope of aluminum (26 Al) chlorohydrate (ACH) was prepared to...

Multi-parameter comparison of a standardized mixed meal tolerance test in healthy and type 2 diabetic subjects: the PhenFlex challenge

Background: A key feature of metabolic health is the ability to adapt upon dietary perturbations. Recently, it was shown that metabolic challenge tests in combination with the new generation biomarkers allow the simultaneous quantification of major metabolic health processes. Currently, applied challenge tests are largely non-standardized. A...

Managing the Human Factor in the Incident Investigation Process

Incident investigation and analysis are crucially important parts of the learning from incidents process. They are also highly complex tasks, especially analyzing information to relate "effects" to "causes." It requires the processing and judgment of vast amounts of information under often demanding circumstances like time pressure and lack of...

Microdosing of a Carbon-14 Labeled Protein in Healthy Volunteers Accurately Predicts Its Pharmacokinetics at Therapeutic Dosages

Preclinical development of new biological entities (NBEs), such as human protein therapeutics, requires considerable expenditure of time and costs. Poor prediction of pharmacokinetics in humans further reduces net efficiency. In this study, we show for the first time that pharmacokinetic data of NBEs in humans can be successfully obtained early...

Metabolic profile of a continuous versus a cyclic low-dose combined oral contraceptive after one year of use

Objectives?To compare the effects of a combined oral contraceptive (COC) taken continuously with those of one of similar composition taken cyclically on 30 variables related to haemostasis, lipids, carbohydrates, bone metabolism, and sex hormone-binding globulin (SHBG). Methods?Randomised, open-label, multicentre, comparative substudy of a...

Evaluation of metabolite profiles as biomarkers for the pharmacological effects of thiazolidinediones in type 2 diabetes mellitus patients and healthy volunteers

Aims: To explore the usefulness of metabolomics as a method to obtain a broad array of biomarkers for the pharmacological effects of rosiglitazone (RSG) in plasma and urine samples from patients with type 2 diabetes mellitus (T2DM) and healthy volunteers (HVs). Additionally, we explored the differences in metabolite concentrations between T2DM...

Comparison of the impact of vaginal and oral administration of combined hormonal contraceptives on hepatic proteins sensitive to estrogen

Objective: We evaluated the effects of a new combined hormonal contraceptive vaginal ring (CVR) delivering the nonandrogenic progestin Nestorone® (NES) and ethinyl estradiol (EE) on several key estrogen-sensitive hepatic proteins that may be markers for the risk of arterial or venous disease events and on blood pressure (BP). Because the...

Effect of garlic powder on C-reactive protein and plasma lipids in overweight and smoking subjects

Background: Epidemiologic studies suggest that garlic may have beneficial effects on risk factors associated with cardiovascular disease (CVD). However, these findings are not unambiguously supported by randomized placebo-controlled clinical trials. Objective: We sought to investigate the effects of a chemically well-characterized garlic...

Comparative effects of a contraceptive vaginal ring delivering a nonandrogenic progestin and continuous ethinyl estradiol and a combined oral contraceptive containing levonorgestrel on hemostasis variables

Objective: This study aimed to compare the effects on hemostasis variables of a contraceptive vaginal ring with those of an oral contraceptive. Study design: Twenty-three and 22 healthy premenopausal women were randomized to the contraceptive vaginal ring (150 μg Nestorone and 15 μg ethinyl estradiol) or Stediril 30 during 3 cycles. Analysis of...

Disagreement between bedside and laboratory activated partial thromboplastin time and international normalized ratio for various novel anticoagulants

During studies on warfarin, heparin and various anticoagulants with novel mechanisms of action, the activated partial thromboplastin time (aPTT) and the (apparent) international normalized ratio (INR) from a bedside monitor (Coagucheck Plus®) were compared with laboratory assay results. Data were compared using the Bland and Altman method of...

The oral bioavailability of pentosan polysulphate sodium in healthy volunteers

Objective: Pentosan polysulphate sodium (PPS), a heparin-like drug, is supposed to be orally applicable. The objective of the present study was to assess the oral bioavailability of PPS. However, since specific assays for PPS do not exist, this was done by using primary and secondary effect parameters. Methods: The study was carried out using a...