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生命科学公司(OTCQB:NMLSF),一家专注于研发裸盖菇素类药物的生物技术公司1.5 mg裸盖菇素微剂量胶囊符合要求与化学、制造和控制(CMC)发布的指南。
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的新化合物将用于支持微剂量裸盖菇素治疗脆性X综合征(FXS)II/a期临床试验应用于加拿大卫生部,与合作伙伴合作完成临床研究机构合作伙伴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.
该公司正在召集供该机构审查的必要文件包括裸盖菇素活性药物成分(API)的第二阶段制造工艺文件、成品批量生产记录和符合法规的胶囊溶出参数。
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.
为Nova的首席运营官杰奎琳·麦康奈尔GMP级裸盖菇素微剂量胶囊的生产构成了该公司自闭症谱系障碍(ASD)临床研究计划的“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,麦康奈尔表示,如果获得批准,Nova的新裸盖菇素胶囊将向加拿大的医生、诊所和制药公司提供,用于非自闭症临床试验的潜在治疗用途,如糖尿病、心脏病、癫痫和创伤后应激障碍。
Photo courtesy of Chanya Tachae and content_creator on Shutterstock.
照片由Chanya Tachae和内容创作者在Shutterstock上提供。
译文内容由第三方软件翻译。
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