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Bioanalytical Part

Facilities: 

  • LC-MC/MS systems. {(UP) LC-MS – Waters}

  • HPLC System:

    • Agilent

  •  Microbalance.

  • All study samples are stored in controlled freezers (-20°C and -70°C).

  • UPS (Uninterrupted Power Supply) and generator back-up.

  • Services

    • Method Development.

    • Method Validation.

    • Bio-Waiver / Bioequivalence.

Data Management Part

  • Non-compartmental pharmacokinetic analysis using Winnonlin software.
  • Assessments of Bioequivalence.
  • Tabulation, graphical display, analysis and interpretation of study data.
  • 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.
  • Sample Size Estimation and Randomization.

Clinical Part

  • Screening area for physical examination.
  • Sample collection rooms.
  • Complete examination of volunteers with close monitoring during two study phase for the expected AE/SE.
  • Notify the drop-out volunteers with a copy from his analysis report, and follow them up.
  • The BE Center contracted with neuroespitalia hospital.
  • First Aid cupboard.
  • Dining room.
  • Storage freezers ( -80 and -20º C).
  • Archives for secure document storage.

Quality Assurance System

Quality Assurance Unit ensures that studies are performed in accordance with Good Laboratory Practice (GLP)-Good Clinical Practices (GCP) regulations and through in house procedures.
Also, it is responsible for document controlling of study protocols, analysis plans, SOPs & policies; and ensuring the updated versions of these controlled documents are effective and in place or accessible to relevant staff.

QA unit is responsible for regular auditng which 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.

Bioequivalence Center

Bioequivalence Center - Contacts

  • 26 July Mehwar Road intersection with Wahat Road, 6th October City. Egypt.
  • Tel. : (+202) 38371534-5-7/ Ext: 5146
  • becenter@msa.edu.eg
  • Hotline : 16672
  • Center Manager: Dr. Dina Karam +0201129801960
  • QA Manager: Dr. Aya Badr +0201112006907

MSA Repository (MSAR)

MSAR