نتایج جستجو برای: drug safety evaluation
تعداد نتایج: 1576394 فیلتر نتایج به سال:
introduction: drug utilization evaluation (due) studies are designed to assess drug usage appropriateness. dues have traditionally focused on drugs with high price tags, complicated dosage schedules, narrow therapeutic indices and regular side effects. the primary goal of the present study is to evaluate imipenem usage in bone marrow transplantation (bmt) wards. methods: the study was a prospec...
Are medicines dangerous chemicals or life enhancing agents? The answer is ‘Both of those things, often at the same time, and worse in the wrong hands’. In this issue of the Annals, several authors address the problems besetting specialists who assess drug efficacy and safety. The last two articles describe activities (pharmacogenetics, and engineered drug delivery) which may produce unforeseen ...
Safety of drugs is a common concern, regardless of traditional Chinese medicine or Western medicine. Historical experiences tell us that ignored drug safety evaluation would lead to serious consequences. Although Chinese medicine has been used for thousands of years, re-evaluation of the safety is still very important. The criteria for safety of Chinese herbal medicines should be the same as th...
lamotrigine (ltg), a newly developed antiepileptic drug (aed), is efficacious in treating refractory epilepsy. this study was designed to evaluate the efficacy and safety of ltg as add-on therapy in 40 children with refractory epilepsy. the trial was an open-labeled prospective study in children with drug-resistant epilepsy aged <14 years, who had at least 4 seizures per month in spite of recei...
In the last decade, 149 new ethical drug entities have been placed in the hands of the American medical community (1). In each case the two critical determinants to the success or failure of each new compound as a viable product were safety and efficacy. Such data ultimately can only come from trials in patients. However, this must always be preceded by evaluations of safety in animals. It is t...
Blood Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Korea World Health Organization, Regional Office for the Western Pacific, Manila, Philippines National Institute of Infectious Diseases, Tokyo, Japan National Institutes for Food and Drug Control, China Food and Drug Administration, Beijing, China Department of Pharmacolog...
Developing a drug requires great amount of research work in chemistry, manufacturing, controls (CMC), preclinical science and clinical trials. Drug reviewers in regulatory agencies around the world bear the responsibility of evaluating whether the research data support the safety, effectiveness and quality control of a new drug product to serve the public health. This article provides an overvi...
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