Cybin Moves Forward With Clinical Trial On Psilocybin Oral Film
Cybin Inc. (NEO: CYBN) (OTCQB:CLXPF), a biotechnology company focused on progressing psychedelic therapeutics, announced on Tuesday it has received initial clearance to begin a Phase IIa clinical trial on psilocybin for patients suffering from major depressive disorders (MDD).
The head-to-head study will test Cybin’s proprietary sublingual psilocybin formulation against a 25mg psilocybin capsule on 40 patients.
The trial has been approved by a review board at the University of the West Indies in Jamaica, where the research will be undertaken. The company still awaits final confirmation by Jamaica’s Ministry of Health to begin testing the product on human subjects.
Cybin Granted IRB Approval for Phase II Clinical Trials of its Sublingual Psilocybin Formulation for the Treatment of Major Depressive Disorder biospace.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biospace.com Daily Mail and Mail on Sunday newspapers.
Patients with xanthelasma palpebrarum have a higher risk of progression to non-alcoholic fatty liver disease and developing more severe dyslipidemia. Learn more
Physicians Committee Scientists to Present at 2021 Society of Toxicology Meeting
Physicians committee scientists and policy experts will have a lot to contribute at this year’s virtual Society of Toxicology meeting. Members of our team will join other researchers, academics, and representatives from industry to present on pressing matters in the field making sure that nonanimal test methods are front and center at the largest annual gathering of toxicologists anywhere. A Future Framework for Application of In Vitro Metabolism and QIVIVE Models to Inform Risk Assessment
Monday, March 15, 11:15 a.m. – 2:00 p.m. ET
Chairs:
Kelly Magurany, NSF International
Xiaoqing Chang, Integrated Laboratory Systems Inc.
Incorporating Excipients Into QbD Studies For Drug Development â An Introduction
By Brian Carlin (DFE Pharma), Chris Moreton (FinnBrit Consulting), Dave Schoneker (Black Diamond Consulting), Katherine Ulman (KLU Consulting), Joseph Zeleznik (IMCD)
This article is the first in a three-part series based on information from the new guide Incorporation of Pharmaceutical Excipients into Product Development using Quality-by-Design
, published by the International Pharmaceutical Excipients Council Federation (IPEC Federation).
1
The International Conference on Harmonization’s (ICH) guidelines related to quality by design (QbD) primarily ICH Q8, as well as Q9, Q10, Q11, and Q12
2-6 are high level and focus on the active pharmaceutical ingredient (API) and finished drug product. Applying API logic to excipients can lead to counterproductive adaptations inconsistent with QbD principles.