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.
خدمات
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 - Contacts
- تقاطع محور 26 يوليو مع طريق الواحات، مدينة 6 أكتوبر. مصر.
- 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)
