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투여한 경우 발생하는 모든 의도되지 않은 효과를 말하며, 의도되지 않은 바람직한 효과를 포함합니다. 3. 이상사례(Adverse Event/Adverse Experience, AE)란? 의약품등의 투여·사용 중 발생한 바람직하지 않고 의도되지 않은 징후(sign, 예 ; 실험실적...

of the patients developed eye disorders (for example, conjunctivitis, keratoconjunctivitis and keratitis); this adverse event of special interest (AESI) has been attributed to its IL-13 blocking activity93. Higher rates were described in...

Committee of Foreign Investments in the US) and other regulatory approvals being obtained as well as no material adverse event having occurred in relation to PSI [Philly Shipyard],” according to the company statement. “In the event of...

AJ414730 Open in a separate window For allergy sufferers, the only effective way to prevent an adverse reaction in the event of exposure to the allergenic food is to avoid seafood altogether or, in the case of accidental exposure, to...

보고된 부작용 사례는 실제 수치의 1% 남짓이다. R Lazarus, M Klompas. Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP: VAERS). Final Report, U.S. Department of Health and Human Services 2010. Grant ID:R18...

of 201 in the manipulation group (table 4). One (<0·5%) participant in the capsular release group had a serious adverse event from non-trial physiotherapy (table 4). The numbers were insufficient for formal analysis. 33 non-serious...

or required intervention to prevent harm." These incidents "are voluntarily reported to the FDA through its Adverse Event Reporting System known as MedWatch reports." Researchers examined "a total of 467,809 serious adverse events" that...

they plan to measure and track performance throughout the product lifecycle. This could include: Customer surveys Adverse event reports Internal audits Corrective and preventive actions (CAPAs) Nonconformance reports QMS IMPLEMENTATION...

as a dietary supplement. USP conducted a comprehensive safety evaluation of GABA by assessing clinical studies, adverse event information, and toxicology data. Clinical studies investigated the effect of pure GABA as a dietary supplement...