منابع مشابه
Drug Safety Evaluation
Despite the considerable number of newer antibacterials made available over the past decades, amoxicillin, alone or in combination with clavulanic acid, still accounts among the most widely used antibacterial agents. Although they are often considered ‘twin drugs’, they are different both in terms of antibacterial activities and of safety profile. It is well documented that the clavulanate comp...
متن کاملClinical Laboratory Safety Data in Drug Studies
Clinical laboratory measurements are an integral component of most drug studies for two major reasons, firstly to act as an efficacy endpoint in monitoring the success or otherwise of therapy and secondly to ensure patient safety on any new drug or reformulation. The pharmaceutical industry rarely employs physicians and scientists with expertise in clinical laboratory medicine. As such, there i...
متن کاملApplication of morbid animal model in drug safety evaluation of traditional Chinese medicine
During thousands of years of clinical validation and practice, the efficacy and safety of traditional Chinese medicine (TCM) have been widely recognized in the prevention and treatment for various diseases. However, further toxicology research of TCM new drugs is still necessary.
متن کاملPatient-reported outcomes in drug safety evaluation.
The current standard method for adverse symptom monitoring in clinical trials is staff reporting [1, 2]. This is generally conducted via a complex process of data transfer, during which clinicians interview patients and then document impressions in medical charts ad hoc; study personnel abstract these charts and convert reported symptoms to a standard lexicon such as the Common Terminology Crit...
متن کاملAnimal models of human disease in drug safety assessment.
Animal models of human disease have been widely used in drug discovery, but they are rarely utilized in toxicological research and screening (except for transgenic models in carcinogenicity testing). Although genetic and/or acquired pathophysiological alterations associated with a particular disease may greatly exacerbate toxic responses to drugs in certain patient subsets, these pre-existing p...
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ژورنال
عنوان ژورنال: Journal of the Royal Society of Medicine
سال: 1978
ISSN: 0141-0768,1758-1095
DOI: 10.1177/014107687807100912