Overcoming Challenges of Implementing Closed System Transfer Device Clinical In-Use Compatibility Testing for Drug Development of Antibody Drug Conjugates.
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DOI: 10.1016/j.xphs.2019.07.021
Abstract: Closed System Transfer Devices (CSTD) are a supplemental engineering control designed to reduce occupational exposure of hazardous drugs and are currently implemented in accordance to evolving regulations. Due to the novelty and complexity of these… read more here.
Keywords: clinical use; drug; closed system; antibody drug ... See more keywords
Challenges of using closed system transfer devices with biological drug products - An industry perspective.
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DOI: 10.1016/j.xphs.2019.10.042
Abstract: Hazardous drug is a common term used by National Institute of Occupational Health and Safety (NIOSH) to classify medications that may induce adverse mutagenic and reproductive responses in healthcare personnel. NIOSH publishes a list of… read more here.
Keywords: transfer devices; drug products; drug; closed system ... See more keywords