Bioequivalence Studies
Controlled clinical bioequivalence studies in healthy volunteers, supported by integrated clinical, laboratory, pharmacokinetic, and regulatory teams for accurate and submission-ready results.
How the Study Works
1
Screening
2
Dosing
3
Sample Collection
4
Bioanalysis
5
PK & Statistics
6
Clinical Study Report
Clinical Investigation Unit
Controlled Clinical Environment
48-bed clinical unit, separate floor, air-conditioned, emergency unit, physician rooms.
Dosing and Sampling Areas
Dedicated dosing rooms, phlebotomy stations, synchronized clocks for time accuracy.
Sample Retention
−70°C and −20°C freezers with automated temperature alerts.
Pharmacy and Monitoring
Temperature and humidity monitored pharmacy with controlled drug handling.
Advanced Bioanalytical Laboratory
GLP compliant laboratory using LC MS MS systems with validated methods and CFR compliant software.
Instrumentation Box
LC MS MS
AB Sciex API 6500
AB Sciex API 5500 Plus
AB Sciex API 5500 Q-Trap
AB Sciex API 4500
AB Sciex API 4000 Waters Xevo TQD
HPLC UPLC
Waters UPLC
Waters Alliance HPLC
Agilent 1260
Pharmacokinetics and Statistics
Pharmacokinetic and statistical analysis performed according to FDA guidelines by expert PK scientists and biostatisticians.
Kinetica validated software |
SAS Analytics Pro 9.4 |
R PowerTOST |
Sample size and BE calculations |
Data, Reporting, and Compliance
Electronic CRFs using OpenClinica ensure accurate, organized, and regulatory-compliant capture of all study data from clinical procedures and study subjects.
Comprehensive study documentation is prepared through protocols, informed consent forms, bioequivalence reports, pharmacokinetic reports, bioanalytical reports, and ethical review board submissions.
All activities operate under GCP, GLP, FDA, EMA, ICH, and GCC guidelines with continuous quality assurance oversight, internal audits, secure archiving, and electronic data backup.