Outcomes evaluation barriers

Evaluation of inhibition of the other isoforms is still in the preclinical stages. Inhibition of NHE2 with prostaglandin E2 or with amiloride hastens the reestablishment of barrier function after intestinal ischemic damage in pigs and the use of S-3226 in rats with renal ischemia improved outcomes. Further work examining the effect of inhibition of the other isoforms is still required. 

Comeal organ culture combined with objectively quantifiable assays for comeal epithelial barrier disruption reduces the high variability associated to the subjectively scored Draize Test. The FITC-Dextran retention has been studied as a quantitative evaluation of the comeal epithelial barrier (Lopez et al. 1991) following chemical exposure of bcnzal konium chloride (BAC), Polyquad, and Thimerosal. Sodium dodecyl sulfate (SDS) has also been tested for disruption of the tight junctions via FITC-Dextran retention assay. However, as an objective outcome measure for ocular toxicity, the scoring system is not yet quantitatively comparable for assessment of ocular irritancy to multiple test products. This limitation is similar to surface biotinylation assays. As fluorometry is utilized more extensively in varied laboratories with numerous test chemicals a standardized scoring system can be elicited similar to the familiar Draize Test. 

The purpose of this clinical study was to investigate and evaluate the efficacy and tolerability of a tannic-acid-based medical food, Cesinex (registered name), in fhe freatment of diarrhoea and to investigate the mechanism underlying the antidiarrhoeal effect [84 ]. The product was prescribed to six children and four adults witii diarrhoea. Patients records were retrospectively reviewed for the primary outcome. Cesinex and its major component, tannic acid, were tested for their effects on cholera-toxin-induced intestinal fluid secretion in mice. Polarised human gut epithelial cells (HT29-CL19A cells) were used to investigate the effects of fannic acid on epifhelial barrier properties, transepithelial chloride secretion and cell viability. 

Bow-tie analysis is an analysis technique that combines FTA and ETA together to evaluate multiple possible outcomes from an undesired IE. The various outcomes result from the operation or failure of barriers intended to prevent a mishap. The analysis begins with identification of the IE of concern in the... 

X-tree analysis is an analysis technique that combines FTA and ETA together to evaluate multiple possible outcomes from a UE. The various outcomes result from the operation or failure of barriers intended to prevent a mishap. The analysis begins with identification of the IE of concern in the center. An FTA is performed to identify the causal factors and probability of this event. Then an ETA is performed on all the barriers associated with the IE, and the possibilities of each barrier function failing. The various different failure combinations provide the various outcomes possible, along with the probability of each outcome. X-tree analysis is also referred to as bow-tie analysis. 

The different acceptance criteria apply to losses to personnel and the environment. There are no acceptance criteria concerning losses of material assets. Here, the safety measures are implemented on the basis of cost-benefit considerations. Two of Norskoil s acceptance criteria for risks to personnel use losses of barriers as the undesired outcome rather than injuries or fatalities. The aim here is to guide the risk analyses towards the identification and evaluation of design aspects that have a known relation to risk. 

---