Moomoo AIのまとめ
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、ナスダックに上場している医療テクノロジー企業であるIntelligent Bio Solutions Inc.は、シンボルINBSの下で、Cliantha Researchとの提携を発表し、薬物動態学的スタディを実施することを発表しました。このスタディは、指紋汗中のオピオイドレベルと、コントロールされた薬物の投与後の血液、口腔液、尿液中のオピオイドレベルを比較し、同社のFDA 510(k)臨床スタディプランの主要な構成要素です。この研究には40名の健康な成人対象者が参加し、同社のIntelligent Fingerprinting Drug Screening Syste...すべて展開
2024年2月28日、ナスダックに上場している医療テクノロジー企業であるIntelligent Bio Solutions Inc.は、シンボルINBSの下で、Cliantha Researchとの提携を発表し、薬物動態学的スタディを実施することを発表しました。このスタディは、指紋汗中のオピオイドレベルと、コントロールされた薬物の投与後の血液、口腔液、尿液中のオピオイドレベルを比較し、同社のFDA 510(k)臨床スタディプランの主要な構成要素です。この研究には40名の健康な成人対象者が参加し、同社のIntelligent Fingerprinting Drug Screening SystemとLC-MS/MS分析を利用します。この臨床研究は、非侵襲的薬物スクリーニング技術で米国市場に参入するIntelligent Bio Solutionsの戦略的ステップです。同社は以前、FDAから指針を受けており、同社の薬物スクリーニングカートリッジをII類デバイスとして分類し、マーケティング前にFDAの承認が必要であるとされました。このスタディの募集は2024年3月および4月に行われ、スタディは2024年5月に開始され、サンプル分析は2024年6月末までに終了する予定です。
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