Several clinical trials evaluate conditions associated with pulmonary pathology and diagnostic profiling, including lung transplant rejection, interstitial lung disease, and sarcoidosis. Sponsored by academic and medical institutions such as the University of Alberta, Laval University, and University Hospital Ghent, these studies carry unassigned or not applicable phase classifications and focus on biopsy molecular features and diagnostic yield evaluations. Across these records, recruitment statuses include recruiting, completed, and unknown status.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02812290 | Recruiting | Lung Transplant Rejection |
University of Alberta |
2016-05 | -- |
| NCT02235779 | Unknown status | Interstitial Lung Disease |
Laval University |
2014-08 | Not Applicable |
| NCT00888212 | Completed | Sarcoidosis |
University Hospital Ghent |
2008-06 | 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>).