Magic Mushroom In A Pill? New Microdose Plans Enter Clinical Studies: Here's What Scientists Want To Learn
Magic Mushroom In A Pill? New Microdose Plans Enter Clinical Studies: Here's What Scientists Want To Learn
Nova Mentis Life Science Corp. (OTCQB:NMLSF), a biotech company focused on creating psilocybin-based therapeutics produced 1.5 mg psilocybin microdose capsules compliant with the chemistry, manufacturing and controls (CMC) published guidelines.
NOVA's new compounds would be used in support of a Phase II/a microdose psilocybin for Fragile X Syndrome (FXS) clinical trial application to Health Canada, done in partnership with clinical research organization partner KGK Science Inc.
The company is gathering the necessary documents for the agency to review, including a Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API), finished product batch manufacturing records and regulatory-compliant capsule dissolution parameters.
For NOVA's COO Jacqueline McConnell, the production of GMP-grade psilocybin microdose capsules constitutes "a major breakthrough" in the company's autism spectrum disorder (ASD) clinical research program.
Furthermore, McConnell expressed that, if approved, NOVA's new psilocybin capsules would be made available to doctors, clinics and pharma companies in Canada for potential therapeutic use in non-ASD clinical trials, such as diabetes, heart disease, epileptic conditions and PTSD.
Photo courtesy of Chanya Tachae and content_creator on Shutterstock.
Nova Mentis Life Science Corp. (OTCQB:NMLSF), a biotech company focused on creating psilocybin-based therapeutics produced 1.5 mg psilocybin microdose capsules compliant with the chemistry, manufacturing and controls (CMC) published guidelines.
Nova Mentis生命科學公司(OTCQB:NMLSF),一家專注於研發裸蓋菇素類藥物的生物技術公司1.5 mg裸蓋菇素微劑量膠囊符合要求與化學、製造和控制(CMC)發佈的指南。
NOVA's new compounds would be used in support of a Phase II/a microdose psilocybin for Fragile X Syndrome (FXS) clinical trial application to Health Canada, done in partnership with clinical research organization partner KGK Science Inc.
Nova的新化合物將用於支持微劑量裸蓋菇素治療脆性X綜合徵(FXS)II/a期臨牀試驗應用於加拿大衞生部,與合作伙伴合作完成臨牀研究機構合作伙伴KGK Science Inc.
The company is gathering the necessary documents for the agency to review, including a Phase 2 manufacturing process file for psilocybin active pharmaceutical ingredient (API), finished product batch manufacturing records and regulatory-compliant capsule dissolution parameters.
該公司正在召集供該機構審查的必要文件包括裸蓋菇素活性藥物成分(API)的第二階段製造工藝文件、成品批量生產記錄和符合法規的膠囊溶出參數。
For NOVA's COO Jacqueline McConnell, the production of GMP-grade psilocybin microdose capsules constitutes "a major breakthrough" in the company's autism spectrum disorder (ASD) clinical research program.
為Nova的首席運營官傑奎琳·麥康奈爾GMP級裸蓋菇素微劑量膠囊的生產構成了該公司自閉症譜系障礙(ASD)臨牀研究計劃的“重大突破”。
Furthermore, McConnell expressed that, if approved, NOVA's new psilocybin capsules would be made available to doctors, clinics and pharma companies in Canada for potential therapeutic use in non-ASD clinical trials, such as diabetes, heart disease, epileptic conditions and PTSD.
此外,麥康奈爾表示,如果獲得批准,Nova的新裸蓋菇素膠囊將向加拿大的醫生、診所和製藥公司提供,用於非自閉症臨牀試驗的潛在治療用途,如糖尿病、心臟病、癲癇和創傷後應激障礙。
Photo courtesy of Chanya Tachae and content_creator on Shutterstock.
照片由Chanya Tachae和內容創作者在Shutterstock上提供。
譯文內容由第三人軟體翻譯。
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