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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，在納斯達克上市的股票代碼爲INBS的醫療技術公司Intelligent Bio Solutions Inc. 宣佈與Cliantha Research合作進行藥代動力學研究。這項研究是該公司FDA 510（k）臨床研究計劃的關鍵組成部分，旨在將指紋汗液中的阿片類藥物水平與受控藥物給藥後血液、口服液和尿液中的阿片類藥物水平進行比較。該研究將涉及40名健康的成年受試者，並利用該公司的智能指紋藥物篩選系統以及LC-MS/MS分析。該臨床研究是Intelligent Bio Solutions憑藉其非侵入性藥物篩選技術進入美國市場的戰略的重要一步。該公司此前曾在2023年6月收到美國食品藥品管理局的指導，將其藥物篩選盒歸類爲二類設備，這需要獲得美國食品藥品管理局的批准才能上市。該研究的招募預計將於2024年3月和4月進行，研究於5月開始，樣本分析將於2024年6月底結束。
2024年2月28日，在納斯達克上市的股票代碼爲INBS的醫療技術公司Intelligent Bio Solutions Inc. 宣佈與Cliantha Research合作進行藥代動力學研究。這項研究是該公司FDA 510（k）臨床研究計劃的關鍵組成部分，旨在將指紋汗液中的阿片類藥物水平與受控藥物給藥後血液、口服液和尿液中的阿片類藥物水平進行比較。該研究將涉及40名健康的成年受試者，並利用該公司的智能指紋藥物篩選系統以及LC-MS/MS分析。該臨床研究是Intelligent Bio Solutions憑藉其非侵入性藥物篩選技術進入美國市場的戰略的重要一步。該公司此前曾在2023年6月收到美國食品藥品管理局的指導，將其藥物篩選盒歸類爲二類設備，這需要獲得美國食品藥品管理局的批准才能上市。該研究的招募預計將於2024年3月和4月進行，研究於5月開始，樣本分析將於2024年6月底結束。
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