Metrics Research offers Bioequivalence (BE) and Bioavailability (BA) study services through its full-fledged, state of the art Metrics Research Center (MRC).

Up to 13 Bioequivalence Studies (BE) have been conducted at the BE Study Facility for international clients.

Recently, Ministry of Interior and Narcotics Control of the Government of Pakistan gave its approval by endorsing Metrics Research Center as a competent authority for import / local purchase of Narcotics and Psychotropic Substances for research purposes – MRC in effect achieved a milestone by becoming the 1st BE/BA facility approved by the Government of Pakistan.

MRC is a modern ISO 9001:2008 certified, fully air‐conditioned, custom‐designed, BE/BA clinical facility spanning 24,600 sq ft across 6 levels in a detached commercial building in D.H.A, Karachi.
The MRC facility, its systems and procedures were designed to meet international standards, such as ISO 9001‐2008 Quality Management System, ICH-GCP, US FDA, EMEA, Health Canada, TGA Canada, WHO, and DRAP requirements for the conduct of BE/BA Studies.
 Globally Compliant BE/BA Facility


Globally Compliant BE/BA Facility

1. FACILITY FEATURES

  • State of the art, air-conditioned, custom-designed MRC’s Bioequivalence and Bioavailability study facility covering  24,600 square feet across 6 levels in a detached commercial building in Karachi, Pakistan.
  • This BE/BA facility and its systems and procedures were designed to meet international standards, such as ISO 9001-2008 Quality Management System, ICH, GCP, FDA, EMEA, Health Canada, TGA, WHO, Drug Regulatory Authority of Pakistan (DRAP) formerly known as MoH requirements for the conduct of BE/BA studies.
  • MRC’s facility was inspected / audited and approved by DRAP.
  • Electronic security card-access, 24/7 security personnel, and a generator powered system allowing for secure and uninterrupted operations.
  • Fully monitored and temperature controlled freezer room and pharmacy.
  • Total # of 96 beds with separate dormitories for male and female volunteers:
    Clinic # 1: 28+4 beds
    Clinic # 2: 28+4 beds
    Clinic # 3: 28+4 beds

2. SERVICES OFFERED BY METRICS RESEARCH CENTER (MRC)

  • Bioequivalence (BE)/ Bioavailability (BA) Studies in Health Volunteers and Patients
    • Pilot Studies
    • Pivotal studies
      • Fasting studies
      • Fed/Food-effect studies
      • Single-dose studies
      • Multiple-dose studies
    • Pharmacokinetic (PK)/Pharmacodynamic (PD) Studies in Healthy
    • Volunteers and Patients
    • Single-Dose Escalation PK Studies
    • Multiple-Dose Escalation PK Studies
    • Drug-Drug Interaction PK Studies
  • Phase I/IIa (including First in Patient Studies, PK/PD Studies in Patients)
  • Clinical Endpoint Studies

3. SUPPORT SERVICES

  • Project Management
  • Study design
  • Protocol writing
  • Pharmacokinetic analysis
  • Statistical analysis
  • Bioanalysis
  • Report writing
  • Quality control and quality assurance
  • Regulatory affairs (CTA)

4. SUBJECT POPULATION

  • Healthy Volunteers (males and females)
  • Special Populations (postmenopausal obese, elderly, slow/fast metabolizers)
  • Renal, Hepatically – Impaired Patients and Cancer Patients
  • Other Patient Populations (through Metric Research’s Investigator Network)
    • Rheumatoid Arthritis/Osteoarthritis
    • Infectious Diseases
    • Cardiology
    • Neurology
    • Respiratory
    • Dermatology
    • Endocrinology/Metabolism
    • Women’s Health
    • Ophthalmology
    • Oncology