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The Bioanalytical laboratory is equipped with latest models of GCs and HPLCs with auto injectors and UV-VIS, fluorescence, electrochemical, refractive index detectors and LC-MS/MS etc.
Clinical section:
It consists of:
- Ward of 30 beds.
- ICU.
- Doctor’s work station.
- Volunteer screening section.
- Phlebotomy stations.
- Pharmacy.
- Sample processing rooms.
- Recreation center.
- Pantry and Cafeteria.
- Sample storage area.
- Sophisticated softwares like WinNonLin & SAS.
Bioanalytical section:
It consists of:
- Sample processing section.
- HPLC with various detectors including MS-MS like API 365, 2000, 3000 (2nos), 4000 (2nos).
- Other automated instruments for sample processing.
- Method development, Method validations and documentations to ICH guidelines.
- Data management system.
Services such as:
- Bioequivalence evaluations of generic products.
- Dose proportionality bioavailability studies.
- Therapeutic drug monitoring.
- Evaluation of new drug delivery systems.
- Food effect studies.
- Evaluation of controlled and extended release dosage forms.
Quality Assurance:
In compliance with the GCP and GLP guidelines, in-house quality assurance audits are routinely performed for the facility, systems and individual projects. A quality audit plan is drawn to ensure that the data are of consistent quality.
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