Besifloxacin Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

In a clinical trial sponsored by Bausch & Lomb Incorporated, researchers evaluated besifloxacin in healthy human volunteers. This completed, randomized, masked Phase 1 study compared the conjunctival penetration and tissue concentrations of besifloxacin alongside gatifloxacin and moxifloxacin. The findings provide essential comparative pharmacokinetic insights into the localized ocular delivery of this ophthalmic agent.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00905762	Completed	Healthy	Bausch & Lomb Incorporated	2009-03	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Besifloxacin binds to and inhibits bacterial DNA gyrase and topoisomerase IV, thereby blocking DNA replication and transcription to induce rapid bacterial cell death. This bactericidal activity prevents pathogen proliferation, supporting its Phase 1 clinical evaluation of ocular tissue penetration in healthy subjects for the treatment of bacterial conjunctivitis.

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>).