Bioequivalence/Bioavailability

Our bioanalytical unit is truly one of our core competencies. It spreads over 400m2 area and offers a comprehensive assay development, validation and sample analysis techniques in biological samples using advanced high-tech equipment's. Our Culminated experience includes more than 85 validated methods, to quantitatively measure drugs and/or metabolite(s) in biological matrices. Our state-of-the-art instruments are subject to rigorous qualification and PM programs.

  • We have access to organic synthesis suppliers, which insures that the necessary metabolites and internal standards including labelled compounds are available to conduct the most demanding studies.
  • All study samples are stored in controlled freezers (-20°C and -70°C) and continuously monitored with 24-hour mobile-call alarms; and supported by a standby generator & UPS system
  • Maintenance of high quality standards as required by GLP principles.

Our set-up of Bioanalytical Lab

Laboratories of the bioanalytical unit are equipped with:

LC-MC/MS systems:

  • AB Sciex API 3000
  • AB Sciex API 4000

Four HPLCs:    

Waters HPLC systems with UV Detectors and FL Detectors

  • Automated96 well autosamplers
  • Watson™ LIMS for secure data processing & warehousing
  • Refrigerated centrifuges
  • Milli Q water
  • Microbalance & ultramicrobalance

In-house medical laboratory providing full medical screening tests, including hematology, coagulation, platelet aggregation, chemistry, drug testing & urinalysis testing.

The lab is equipped with the following instruments:

  • Beckman Coulter® AC.T diff TM Hematology Analyzer
  • Roche Cobas® c 111 Chemistry Analyzer with AVL 9180 Electrolyte Analyzer
  • Human® Semiautomated Chemistry Analyzer
  • Linear® ELISA reader and washer
  • Human® Coagulometer

Data Management Services

Pharmacokinetic & Statistical Analysis

  • Non-compartmental pharmacokinetic analysis using validated KineticaTM software
  • Sample size and power calculation using SAS® software
  • Assessments of Bioequivalence/Bioavailability
  • Tabulation, graphical display, analysis and interpretation of study data
  • Preparation of stand-alone or summary reports

Data Management & Medical Writing

  • Study design and development of Protocol and Informed Consent Form (ICF)
  • Designing of Case Report Form (CRF) as per protocol requirements
  • Preparation of Bioequivalence Report, Clinical Report, Analytical Report and Statistical Report

Quality Assurance Services

Quality Assurance Unit is to ensure that studies are performed in accordance with Good Laboratory Practice (GLP)-Good Clinical Practices (GCP) regulations and in house procedures.

Responsible for document control of study protocols, analysis plans, SOPs & policies; and ensures updated versions of these controlled documents are effective and in place or accessible to relevant staff.

Our audits include:

  • Study source documentation, procedures, and reports; and provides regulatory advice and support to the operational staff.
  • Facility & system, to check adequacy & eligibility of resources and proper utilization of provisions

Clinical Pharmacology Unit

  • 60-bed dormitories & 10-bed clinical ward
  • Clinical Site-IRB
  • A dedicated screening area with physical examination and sample collection rooms
  • A secure pharmacy with temperature control
  • A dining room
  • A recreation lounge
  • Multiple dosing and phlebotomy stations room
  • ICU-ER with access to proximal hospital ICUs
  • An on-site processing laboratory with -70 and -20º C storage freezers
  • Synchronized clocks to facilitate standardized times entries
  • A backup generator
  • Camera monitoring/recording for the interior and exterior of the facility
  • Computerized temperature monitoring system for freezers programmed to alert (mobile call) assigned staff members of excursions
  • Access-controlled rooms
  • Fireproof Archives safe for secure document storage
  • Walk-In freezers with temperature monitoring and alarm system, for long-term storage of study samples