Home About us Contact
|
Home About us Contact | ||
|
|
||
Safety Record (safety + record)
Selected AbstractsProgress towards achieving new vaccine and vaccination goalsINTERNAL MEDICINE JOURNAL, Issue 7 2003G. Ada Abstract Viral and bacterial vaccines, especially for childhood use, are one of the most successful public health measures of the last two centuries and have a good safety record. However, there are still many diseases that are caused by infectious agents for which vaccines are not available. Our increasing ability to manipulate the immune system offers hope that, in the future, at least some of these infections may be prevented by vaccination. A surprising recent development is the use of vaccine technology to test whether a range of other generally non-communicable diseases can be prevented (or at least controlled) in this way. Investigation of these diseases is still mainly at the experimental level, however the list includes different types of cancers, allergies, drug addiction and neurodegenerative diseases. (Intern Med J 2003; 33: 297,304) [source] Methotrexate in psoriasis: 26 years' experience with low-dose long-term treatmentJOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY & VENEREOLOGY, Issue 5 2000U-F. Haustein Abstract Objective,To evaluate the efficacy, safety and side-effects of methotrexate (MTX) in psoriasis. Design,A 26-year retrospective study. Setting,Department of Dermatology, Leipzig University, Leipzig, Germany. Patients,One hundred and fifty-seven patients with extensive plaque psoriasis, erythrodermic, pustular and arthropathic forms, were treated with low-dose methotrexate (15,20 mg maximum weekly dosage [Weinstein schedule]), the majority for long-term periods. The mean cumulative dose was 3394 mg, the mean duration 237 weeks. Results,The effect of MTX treatment was good in 76%, moderate in 18% and poor in 6% of subjects; 61% experienced side-effects, most frequently due to liver function abnormalities, bone marrow suppression, nausea, gastric complaints and hair loss. In 20% of cases the subjects were forced to discontinue therapy; 9% refused therapy due to physical and psychological discomfort, 2% wanted to become pregnant, 16% were lost to follow-up, 6% died from multimorbidity and old age. Three subjects (2%) developed cancer of the lung, breast or cervix uteri, possibly in relation to long-term MTX treatment. Altogether there were no deaths or life-threatening side-effects attributable to MTX treatment, and no cases of progressive liver cirrhosis apart from two extensive skin necroses due to overdosage (misunderstanding, suicidal attempt) that were treated successfully with citrovorum factor. Conclusion,Low-dose MTX (<15,20 mg/week) is an effective therapy for extensive and severe forms of psoriasis if patients are selected carefully and monitored regularly, particularly with respect to liver and bone marrow toxicity. This helps to reduce severe side-effects even during long-term treatment. Drug interactions must be avoided. MTX therapy according to the guidelines is relatively safe and still has a place in the systemic treatment of psoriasis with 40 years of experience and an acceptable safety record. [source] First Exposure in Man: Toxicological ConsiderationsBASIC AND CLINICAL PHARMACOLOGY & TOXICOLOGY, Issue 2000Per Spindler Recommendations on the type and extent of preclinical safety studies that should be conducted prior to first dose in man have been developed by the International Conference on Harmonisation, and the European Committee for Proprietary Medicinal Products. These recommendations include studies designed to characterise local tolerance and general toxicity of the drug candidate as well as its genotoxic potential and ability to interfere with reproduction. For trials which can be categorised as low dose PK screening trials and trials with products where rodent and non-rodent (primarily dog) models do not show any biological response (e.g. some biotechnology-derived hormones and cytokines) other testing paradigms should be used. The present recommendations for preclinical testing have had an important impact on the documented impressive safety record of phase I clinical trials. In this spirit we extend our warmest and sincerest thanks to Professor Jens S. Schou for his long and deep engagement in European and International harmonisation of preclinical test recommendations. His efforts have had a substantial impact on the present testing recommendations, which are of obvious benefit to the safety of the patient. [source] Productivity,quality,costs,safety: A sustained approach to competitive advantage,a systematic review of the national safety council's case studies in safety and productivityHUMAN FACTORS AND ERGONOMICS IN MANUFACTURING & SERVICE INDUSTRIES, Issue 2 2008Tushyati Maudgalya The marked improvement in workplace safety levels in the past few decades has resulted in companies experiencing fewer safety accidents than before, thus making it less effective to argue that money spent on workplace safety and on injury prevention will yield much bottom-line benefit. To make a compelling business case for workplace safety investment, one must link safety objectives to other business objectives. The objective of this study is to determine whether workplace safety as a business objective adds value to the business bottom line. This research reviews published case studies to determine if there is a relationship between safety initiatives and increased productivity, quality, and cost efficiencies. Eighteen case studies (17 published by the National Safety Council) were analyzed using the Workplace Safety Intervention Appraisal Instrument. The appraisal scores ranged from 0.55 to 1.27, with an average of 0.91. The case studies were relatively strong in the Evidence Reporting and Data Analysis categories, as compared to the Subject Selection, Observation Quality, and Generalization to Other Populations categories. Following workplace safety initiatives, the studies revealed an average increase of 66% (2%,104%) in productivity, 44% (4%,73%) in quality, 82% (52%,100%) in safety records, and 71% (38%,100%) in cost benefits. In a few reported cases, it took only 8 months to obtain a payback in terms of monetary investment in the safety initiative. Although the studies did display a correlation between safety, productivity, and quality, there is insufficient evidence to categorically state that the improvements in productivity, quality, and cost efficiency were brought about by the introduction of an organization-wide safety culture. Notwithstanding, there is demonstrable evidence to indicate that safety as a business objective can assist an organization in achieving the long-term benefit of operational sustainability, that is, achieve a long-term competitive advantage by balancing business costs against social costs. Further research is required to conclusively prove the exact (possibly quantifiable) impact of safety investment on increased productivity, quality, and cost efficiency. © 2008 Wiley Periodicals, Inc. [source] Cyamemazine metabolites: effects on human cardiac ion channels in-vitro and on the QTc interval in guinea pigsJOURNAL OF PHARMACY AND PHARMACOLOGY: AN INTERNATI ONAL JOURNAL OF PHARMACEUTICAL SCIENCE, Issue 11 2008William Crumb Monodesmethyl cyamemazine and cyamemazine sulfoxide, the two main metabolites of the antipsychotic and anxiolytic phenothiazine cyamemazine, were investigated for their effects on the human ether-à-go-go related gene (hERG) channel expressed in HEK 293 cells and on native INa, ICa, Ito, Isus or IK1 of human atrial myocytes. Additionally, cyamemazine metabolites were compared with terfenadine for their effects on the QT interval in anaesthetized guinea pigs. Monodesmethyl cyamemazine and cyamemazine sulfoxide reduced hERG current amplitude, with IC50 values of 0.70 and 1.53 ,M, respectively. By contrast, at a concentration of 1 ,M, cyamemazine metabolites failed to significantly affect INa, Ito, Isus or IK1 current amplitudes. Cyamemazine sulfoxide had no effect on ICa at 1 ,M, while at this concentration, monodesmethyl cyamemazine only slightly (17%), albeit significantly, inhibited ICa current. Finally, cyamemazine metabolites (5 mg kg,1 i.v.) were unable to significantly prolong QTc values in the guinea pig. Conversely, terfenadine (5 mg kg,1 i.v.) significantly increased QTc values. In conclusion, cyamemazine metabolite concentrations required to inhibit hERG current substantially exceed those necessary to achieve therapeutic activity of the parent compound in humans. Moreover, cyamemazine metabolites, in contrast to terfenadine, do not delay cardiac repolarization in the anaesthetized guinea pig. These non-clinical findings explain the excellent cardiac safety records of cyamemazine during its 30 years of extensive therapeutic use. [source] | ||||||||||