Several clinical trials evaluate interventions associated with this compound dataset across diverse conditions, including midshaft clavicle fractures, elevated perimenopausal blood pressure, and pediatric primary care HIV testing protocols. Designated as Phase Not Applicable, these studies are led by academic or institutional sponsors, including the University of Minnesota, The University of Texas Medical Branch Galveston, and Yale University in partnership with the National Institute of Mental Health. None are currently recruiting, with individual statuses listed as either suspended or not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05454306 | Suspended | Clavicle Fracture |
University of Minnesota |
2028-01-09 | Not Applicable |
| NCT06376812 | Not yet recruiting | Elevated Blood Pressure|Perimenopause |
The University of Texas Medical Branch Galveston |
2026-05 | Not Applicable |
| NCT06279949 | Not yet recruiting | Hiv |
Yale University|National Institute of Mental Health (NIMH) |
2026-04 | Not Applicable |
(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>).