Multiple clinical trials evaluate conditions associated with this profile, focusing on mobile application interventions for expectant fathers, intrapartum ultrasound during labor, exercise regimens for chronic lung and cardiopulmonary disease, and attachment tracking in perinatal disorders. Sponsored by academic and clinical institutions such as Pamukkale University, the University of Padova, Columbia University, and Fundación IVI, these studies feature phases categorized as Not Applicable or unassigned. Recruitment statuses across the trials range from not yet recruiting to actively recruiting and completed.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT06168656 | Not yet recruiting | Mobile Application|Expectant Fathers|Antenatal Education |
Pamukkale University |
2023-12-31 | Not Applicable |
| NCT05718180 | Not yet recruiting | Labor Obstetric |
University of Padova|Azienda Ospedaliera di Padova |
2023-06-01 | Not Applicable |
| NCT05776264 | Completed | Chronic Lung Disease|Cardiopulmonary Disease |
Columbia University |
2023-03-29 | Not Applicable |
| NCT05895175 | Recruiting | Perinatal Disorder |
Fundación IVI |
2022-07-01 | -- |
(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>).
- Phosphonoacetic acid Solubility in DMSO
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