Home About us Contact | |||
Tolerance Limits (tolerance + limit)
Selected AbstractsComparative evaluation of quality of doxycycline formulations registered in Estonia to those registered in the Russian FederationDRUG DEVELOPMENT RESEARCH, Issue 2 2008A. Meos Abstract The in vitro properties of four Estonian drug market (manufactured in Austria, Germany, and Finland) and four Russian Federation drug market (manufactured in Belarussia and Russian Federation) doxycycline formulations were evaluated using the estimation of the quantitative content and purity of the active pharmaceutical ingredient (API) and the dissolution test. Tolerance limits were set according to the European Pharmacopoeia (for the content and purity of the API) and USP (for the dissolution test) doxycycline monographs. All Estonian drug market doxycycline formulations complied with the tolerance limits in all tests and assays. Most of the Russian Federation drug market doxycycline formulations also passed the tolerance limits, with two minor exceptions: one formulation contained quantitatively API below the USP limit (83.7% instead of the 90%), but all the API was readily released in the dissolution test, the other formulation (capsules) released 80% of API in 39,min instead of 30,min. The general conclusion of the study is that despite some deviations, the Russian Federation drug market doxycycline formulations are comparable with those purchased from the Estonian drug market. Drug Dev Res 69: 58,68, 2008. © 2008 Wiley-Liss, Inc. [source] Long-term storage influence on volatile amines (TVB-N and TMA-N) in sardines and herring utilized as food for tuna fatteningJOURNAL OF APPLIED ICHTHYOLOGY, Issue 6 2009imat Summary The study investigated the influence of volatile amines, total volatile bases nitrogen (TVB-N) and trimethylamine nitrogen (TMA-N) quantities in sardines (Sardina pilchardus) and herring (Clupea harengus) after 1 year of frozen storage. TVB-N quantities for both species were within the tolerance limit (25,35 mg/100 g). TVB-N and TMA-N increase factors over the initial values for sardines were 1.6 and 4.9, and 1.4 and 3.6 for herring. Results showed that TMA-N quantities were twice those registered as acceptable for these species, rendering the analysed fish unsuitable for tuna fattening. Previously registered increases in tuna mortalities were caused by secondary bacterial infection (pasteurellosis) from these baitfish. Tissue samples from diseased animals and the control group differed widely in their histological architecture, suggesting that rearing conditions, e.g. quality of administered baitfish, indirectly influenced tuna health. [source] Effects of temperature and salinity on the survival and development of mud crab, Scylla serrata (Forsskål), larvaeAQUACULTURE RESEARCH, Issue 14 2007Rahmi Nurdiani Abstract The combined effects of temperature and salinity on larval survival and development of the mud crab, Scylla serrata, were investigated in the laboratory. Newly hatched larvae were reared under 20 °C temperature and salinity combinations (i.e. combinations of four temperatures 25, 28, 31, 34 °C with five salinities 15, 20, 25, 30, 35 g L,1). The results showed that temperature and salinity as well as the interaction of the two parameters significantly affected the survival of zoeal larvae. Salinity at 15 g L,1 resulted in no larval survival to the first crab stage, suggesting that the lower salinity tolerance limit for mud crab larvae lies somewhere between salinity 15 and 20 g L,1. However, within the salinity range of 20,35 g L,1, no significant effects on survival of zoeal larvae were detected (P>0.05). The combined effects of temperature and salinity on larval survival were also evident as at low salinities, both high and low temperature led to mass mortality of newly hatched larvae (e.g. 34 °C/15 g L,1, 34 °C/20 g L,1 and 25 °C/15 g L,1 combinations). In contrast, the low temperature and high salinity combination of 25 °C/35 g L,1 resulted in one of the highest survival to the megalopal stage. It was also shown that at optimal 28 °C, larvae could withstand broader salinity conditions. Temperature, salinity and their interaction also significantly affected larval development. At 34 °C, the mean larval development time to megalopa under different salinity conditions ranged from 13.5 to 18.5 days. It increased to between 20.6 and 22.6 days at 25 °C. The effects of salinity on larval development were demonstrated by the fact that for all the temperatures tested, the fastest mean development to megalopa was always recorded at the salinity of 25 g L,1. However, a different trend of salinity effects was shown for megalopae as their duration consistently increased with an increase in salinity from 20 to 35 g L,1. In summary, S. serrata larvae tolerate a broad range of salinity and temperature conditions. Rearing temperature 25,30 °C and salinity 20,35 g L,1 generally result in reasonable survival. However, from an aquaculture point of view, a higher temperature range of 28,30 °C and a salinity range of 20,30 g L,1 are recommended as it shortens the culture cycle. [source] Comparative evaluation of quality of doxycycline formulations registered in Estonia to those registered in the Russian FederationDRUG DEVELOPMENT RESEARCH, Issue 2 2008A. Meos Abstract The in vitro properties of four Estonian drug market (manufactured in Austria, Germany, and Finland) and four Russian Federation drug market (manufactured in Belarussia and Russian Federation) doxycycline formulations were evaluated using the estimation of the quantitative content and purity of the active pharmaceutical ingredient (API) and the dissolution test. Tolerance limits were set according to the European Pharmacopoeia (for the content and purity of the API) and USP (for the dissolution test) doxycycline monographs. All Estonian drug market doxycycline formulations complied with the tolerance limits in all tests and assays. Most of the Russian Federation drug market doxycycline formulations also passed the tolerance limits, with two minor exceptions: one formulation contained quantitatively API below the USP limit (83.7% instead of the 90%), but all the API was readily released in the dissolution test, the other formulation (capsules) released 80% of API in 39,min instead of 30,min. The general conclusion of the study is that despite some deviations, the Russian Federation drug market doxycycline formulations are comparable with those purchased from the Estonian drug market. Drug Dev Res 69: 58,68, 2008. © 2008 Wiley-Liss, Inc. [source] Detection and delineation of P and T waves in 12-lead electrocardiogramsEXPERT SYSTEMS, Issue 1 2009Sarabjeet Mehta Abstract: This paper presents an efficient method for the detection and delineation of P and T waves in 12-lead electrocardiograms (ECGs) using a support vector machine (SVM). Digital filtering techniques are used to remove power line interference and baseline wander. An SVM is used as a classifier for the detection and delineation of P and T waves. The performance of the algorithm is validated using original simultaneously recorded 12-lead ECG recordings from the standard CSE (Common Standards for Quantitative Electrocardiography) ECG multi-lead measurement library. A significant detection rate of 95.43% is achieved for P wave detection and 96.89% for T wave detection. Delineation performance of the algorithm is validated by calculating the mean and standard deviation of the differences between automatic and manual annotations by the referee cardiologists. The proposed method not only detects all kinds of morphologies of QRS complexes, P and T waves but also delineates them accurately. The onsets and offsets of the detected P and T waves are found to be within the tolerance limits given in the CSE library. [source] Defining safety tolerance limitsJOURNAL OF COSMETIC DERMATOLOGY, Issue 4 2007Zoe Diana Draelos MD Editor-in-Chief [source] Comparison of non-coplanar and coplanar irradiation techniques to treat cancer of the pancreasJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 5 2006C Osborne Summary We compared two different techniques of pancreatic irradiation using measures associated with normal tissue complications. Seven consecutive patients with pancreatic cancer were planned for both coplanar and non-coplanar (NCP) external beam radiation treatments, using the same defined anatomical volumes for each patient, in each case. Each pair of plans was then compared using a range of objective criteria. Individual normal tissues were assessed against traditional tolerance limits. Selected dose-points, normal tissue complication probability (NTCP) and equivalent uniform doses (EUD) were also compared, as were indices combining information from individual tissues , total NTCP and total weighted EUD. All individual normal tissues doses were within established tolerance limits. For NCP relative to coplanar planning, NTCP and EUD were lower for all individual tissues in four cases and one case, respectively, i.e. in most cases a benefit to one tissue was offset by detriment to others. Summary measures demonstrated overall benefits for NCP techniques, with the total NTCP in six patients, and with the total weighted EUD in all patients. NCP techniques show potentially useful benefits. We present a new objective measure, the total weighted EUD, which may be particularly useful comparing plans where there are multiple critical tissues. [source] Short-Term Changes in Heat Tolerance in the Alpine Cushion Plant Silene acaulis ssp. excapa [All.] J. Braun at Different AltitudesPLANT BIOLOGY, Issue 6 2000G. Neuner Abstract: The habit of cushion growth positively affects plant temperature but at the same may increase the risk of occasional overheating. In order to determine the adaptive response to short-term heat stress, we exposed S. acaulis cushions at field sites to controlled heat treatments using infrared lamps. Natural diurnal changes in heat tolerance were monitored at alpine sites and at a site distinctly below the natural distribution boundary, where higher temperatures were expected. The range of heat tolerance limits in summer, 45.5 - 54.5 °C (9 K), exceeded that reported for other alpine species (0.1 - 5 K) and even that for total seasonal changes (5 - 8 K). Heat tolerance either increased or decreased on most days (80 %). The maximum diurnal increase was + 4.7 K. Under the experimental conditions heat hardening started at leaf temperatures around 30 °C and proceeded at mean rates of 1.0 ± 0.5 K/h. The onset of functional disturbances in photosystem II also occurred at 30 °C. Heating rates exceeding those naturally found above 30 °C (> 10 K/h) appeared to retard heat hardening. During summer average leaf temperature maxima were 12.4 K (600 m) and 13.0 K (1945 m) higher than air temperature which corroborates the heat trapping nature of cushion plants. At 600 m, as compared to 1945 m, cushions experienced significantly higher leaf temperature maxima (+ 8.8 K) and exceeded 30 °C on most days (80 %). This resulted in a significantly higher heat tolerance (LT50) at 600 m (51.7 ± 0.2 °C) than at 1945 m (49.8 ± 0.2 °C). The fast short-term changes of heat tolerance in summer help S. acaulis to cope with the occasional diurnal short-term heat stress associated with cushion growth. [source] Animal performance and stress: responses and tolerance limits at different levels of biological organisationBIOLOGICAL REVIEWS, Issue 2 2009Karin S. Kassahn ABSTRACT Recent advances in molecular biology and the use of DNA microarrays for gene expression profiling are providing new insights into the animal stress response, particularly the effects of stress on gene regulation. However, interpretation of the complex transcriptional changes that occur during stress still poses many challenges because the relationship between changes at the transcriptional level and other levels of biological organisation is not well understood. To confront these challenges, a conceptual model linking physiological and transcriptional responses to stress would be helpful. Here, we provide the basis for one such model by synthesising data from organismal, endocrine, cellular, molecular, and genomic studies. We show using available examples from ectothermic vertebrates that reduced oxygen levels and oxidative stress are common to many stress conditions and that the responses to different types of stress, such as environmental, handling and confinement stress, often converge at the challenge of dealing with oxygen imbalance and oxidative stress. As a result, a common set of stress responses exists that is largely independent of the type of stressor applied. These common responses include the repair of DNA and protein damage, cell cycle arrest or apoptosis, changes in cellular metabolism that reflect the transition from a state of cellular growth to one of cellular repair, the release of stress hormones, changes in mitochondrial densities and properties, changes in oxygen transport capacities and changes in cardio-respiratory function. Changes at the transcriptional level recapitulate these common responses, with many stress-responsive genes functioning in cell cycle control, regulation of transcription, protein turnover, metabolism, and cellular repair. These common transcriptional responses to stress appear coordinated by only a limited number of stress-inducible and redox-sensitive transcription factors and signal transduction pathways, such as the immediate early genes c-fos and c-jun, the transcription factors NF,B and HIF - 1,, and the JNK and p38 kinase signalling pathways. As an example of environmental stress responses, we present temperature response curves at organismal, cellular and molecular levels. Acclimation and physiological adjustments that can shift the threshold temperatures for the onset of these responses are discussed and include, for example, adjustments of the oxygen delivery system, the heat shock response, cellular repair system, and transcriptome. Ultimately, however, an organism's ability to cope with environmental change is largely determined by its ability to maintain aerobic scope and to prevent loss in performance. These systemic constraints can determine an organism's long-term survival well before cellular and molecular functions are disturbed. The conceptual model we propose here discusses some of the crosslinks between responses at different levels of biological organisation and the central role of oxygen balance and oxidative stress in eliciting these responses with the aim to help the interpretation of environmental genomic data in the context of organismal function and performance. [source] Accountability in Health Care,Transplant Community Offers LeadershipAMERICAN JOURNAL OF TRANSPLANTATION, Issue 6 2009T. E. Hamilton Two concerns expressed by the American Society of Transplant Surgeons (ASTS) are that (1) the new Medicare regulations for transplant hospitals take a ,punitive' approach and that (2) the outcome requirement may thwart innovation by not including certain risk factors into the risk adjustment used to calculate expected outcomes. This article explains efforts by the Centers for Medicare & Medicaid Services (CMS) to encourage quality improvement. CMS limits outcomes-related enforcement to situations where failure rates exceed certain substantial ,tolerance limits', ensuring opportunity for quality improvement to be effective prior to enforcement. Transplantations involving a disproportionate share of risk factors not incorporated into the risk-adjustment methodology can also be raised through CMS',mitigating factors' process. Of the 22 mitigating factor requests completed through March 10, 2009, 7 raised issues of risk adjustment (none involved experimental protocols). Four of the seven requests were approved for other reasons (evidence of effective program changes and improved outcomes). CMS concluded that none of the seven made a persuasive case based on risk factors. The early data indicate that program deficiencies may outweigh risk adjustment issues. CMS agrees to consider the ASTS suggestions for future action and continues to monitor the situation in case a different pattern emerges. [source] |