Clinical Evaluation of Early Post-Marketing Phase Vigilance-Features of Adverse Events Noted in Early Post-marketing Phase Vigilance-
نویسندگان
چکیده
منابع مشابه
Characteristics of adverse drug reactions in a vemurafenib early post-marketing phase vigilance study in Japan
BACKGROUND Post-approval research or monitoring is important to determine real-world safety of new products; however, evidence is scant for vemurafenib in Japanese patients. In Japan, a unique system is officially obligated to investigate post-approval safety. Here we report the first adverse drug reaction (ADR) data from vemurafenib-treated Japanese patients with metastatic melanoma. Data were...
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چکیده پلاتین، فلزی نجیب، پایدار و گران قیمت با خاصیت کاتالیزوری زیاد است که کاربرد های صنعتی فراوانی دارد. کمپلکس های پلاتین(ii) به عنوان دارو های ضد سرطان شناخته شدند و در شیمی درمانی بیماران سرطانی کاربرد دارند. خاصیت کاتالیزوری و عملکرد گزینشی پلاتین مستقیماً به اندازه و- شکل ماده ی پلاتینی بستگی دارد. بعضی از نانو ذرات فلزی در سطح مشترک مایع- مایع سنتز شده اند، اما نانو ساختار های پلاتین ب...
Decision support methods for the detection of adverse events in post-marketing data.
Spontaneous reporting is a crucial component of post-marketing drug safety surveillance despite its significant limitations. The size and complexity of some spontaneous reporting system databases represent a challenge for drug safety professionals who traditionally have relied heavily on the scientific and clinical acumen of the prepared mind. Computer algorithms that calculate statistical meas...
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A 2008 review by our group concluded that the risk of neuropsychiatric adverse events (NPAEs) in influenza patients was not increased by oseltamivir exposure, and did not identify any mechanism by which oseltamivir or its metabolites could cause or worsen such events. The current article reviews new information on this topic. Between September 16, 2007 and May 15, 2010, 1,805 spontaneously-repo...
متن کاملEffects on vigilance performance and sleepiness of alcohol given in the early afternoon ('post lunch') vs. early evening.
There is a propensity for sleepiness in the early afternoon ('post-lunch dip'), that contrasts with the circadian peak of alertness in the evening. Alcohol has a soporific effect, and one might expect it to be more potent in the early afternoon than in the evening. This is a little explored area. Four, two or nil (English) units of alcohol (producing maximum blood alcohol concentrations [BACs] ...
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ژورنال
عنوان ژورنال: Iryo Yakugaku (Japanese Journal of Pharmaceutical Health Care and Sciences)
سال: 2005
ISSN: 1882-1499,1346-342X
DOI: 10.5649/jjphcs.31.632