CHAPS Clinical Trials

Size	Price	Qty
100mg	USD 99
1g	USD 217

Clinical Trials

A clinical trial sponsored by Duke University evaluated applications related to CHAPS within healthcare infrastructure settings. This completed study, categorized under a phase designation of Not Applicable, focused on health service frameworks and organizational outcomes, specifically clinical decision support, medical informatics interventions, population health management, and healthcare quality. Overall, the trial evaluated health information delivery across community networks rather than targeting pharmacological interventions.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00365885	Completed	Clinical Decision Support\|Medical Informatics Interventions\|Population Health Management\|Quality of Healthcare	Duke University	2006-08	Not Applicable

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the CHAPS product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a zwitterionic surfactant, CHAPS interacts directly with nucleosomal complexes to perturb histone-DNA interactions, thereby decreasing the sequence specificity of the nucleosome and altering chromatin accessibility. This destabilization of chromatin structure alters nuclear biochemistry and gene regulatory dynamics, which provides a key analytical basis for molecular assays evaluated in clinical decision support, medical informatics interventions, population health management, and quality of healthcare research.

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>).