Several clinical trials are currently actively recruiting across diverse therapeutic areas, investigating acute ischemic stroke involving vascular occlusion, electronic cigarette use and abuse liability, and functional impairments in Parkinson's disease. Across these records, trial phases are categorized as unassigned or not applicable. The studies are sponsored by academic and healthcare institutions, including the Affiliated Hospital of Southwest Medical University, Virginia Commonwealth University alongside the National Institute on Drug Abuse, and Sanko University.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06125236 | Recruiting | Acute Ischemic Stroke |
Zhengzhou Yuan|The Affiliated Hospital Of Southwest Medical University |
2023-11-09 | -- |
| NCT05971823 | Recruiting | Electronic Cigarette Use |
Virginia Commonwealth University|National Institute on Drug Abuse (NIDA) |
2023-07-31 | Not Applicable |
| NCT06146283 | Recruiting | Parkinson Disease |
Sanko University |
2023-06-01 | -- |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).