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On February 28, 2024, Intelligent Bio Solutions Inc., a medical technology company listed on Nasdaq under the symbol INBS, announced a partnership with Cliantha Research to conduct a pharmacokinetic study. This study is a key component of the company's FDA 510(k) clinical study plan, aiming to compare the levels of opiates in fingerprint sweat with those in blood, oral fluid, and urine after controlled drug administration. The study will involve 40 healthy adult subjects and utilize the company's Intelligent Fingerprinting Drug Screening System alongside LC-MS/MS analysis. The clinical study is a significant step in Intelligent Bio Solutions' strategy to enter the US market with its non-invasive drug screening technology. The company had previously received guidance from the FDA in June 2023, classifying its drug screening cartridge as a Class II device, which requires FDA clearance before marketing. The recruitment for the study is expected to occur in March and April 2024, with the study commencing in May and sample analysis concluding by the end of June 2024.
On February 28, 2024, Intelligent Bio Solutions Inc., a medical technology company listed on Nasdaq under the symbol INBS, announced a partnership with Cliantha Research to conduct a pharmacokinetic study. This study is a key component of the company's FDA 510(k) clinical study plan, aiming to compare the levels of opiates in fingerprint sweat with those in blood, oral fluid, and urine after controlled drug administration. The study will involve 40 healthy adult subjects and utilize the company's Intelligent Fingerprinting Drug Screening System alongside LC-MS/MS analysis. The clinical study is a significant step in Intelligent Bio Solutions' strategy to enter the US market with its non-invasive drug screening technology. The company had previously received guidance from the FDA in June 2023, classifying its drug screening cartridge as a Class II device, which requires FDA clearance before marketing. The recruitment for the study is expected to occur in March and April 2024, with the study commencing in May and sample analysis concluding by the end of June 2024.
2024年2月28日，在纳斯达克上市的股票代码为INBS的医疗技术公司Intelligent Bio Solutions Inc. 宣布与Cliantha Research合作进行药代动力学研究。这项研究是该公司FDA 510（k）临床研究计划的关键组成部分，旨在将指纹汗液中的阿片类药物水平与受控药物给药后血液、口服液和尿液中的阿片类药物水平进行比较。该研究将涉及40名健康的成年受试者，并利用该公司的智能指纹药物筛选系统以及LC-MS/MS分析。该临床研究是Intelligent Bio Solutions凭借其非侵入性药物筛选技术进入美国市场的战略的重要一步。该公司此前曾在2023年6月收到美国食品药品管理局的指导，将其药物筛选盒归类为二类设备，这需要获得美国食品药品管理局的批准才能上市。该研究的招募预计将于2024年3月和4月进行，研究于5月开始，样本分析将于2024年6月底结束。
2024年2月28日，在纳斯达克上市的股票代码为INBS的医疗技术公司Intelligent Bio Solutions Inc. 宣布与Cliantha Research合作进行药代动力学研究。这项研究是该公司FDA 510（k）临床研究计划的关键组成部分，旨在将指纹汗液中的阿片类药物水平与受控药物给药后血液、口服液和尿液中的阿片类药物水平进行比较。该研究将涉及40名健康的成年受试者，并利用该公司的智能指纹药物筛选系统以及LC-MS/MS分析。该临床研究是Intelligent Bio Solutions凭借其非侵入性药物筛选技术进入美国市场的战略的重要一步。该公司此前曾在2023年6月收到美国食品药品管理局的指导，将其药物筛选盒归类为二类设备，这需要获得美国食品药品管理局的批准才能上市。该研究的招募预计将于2024年3月和4月进行，研究于5月开始，样本分析将于2024年6月底结束。
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