Bioequivalence (BE) studies
- Conduction of various BE study designs e.g. Cross-over, parallel, partial
replicate, full replicate, fast and fed studies.
- An efficient recruitment system that includes a big database of healthy
volunteers selected through a comprehensive screening process that
guarantees the implementation of the highest eligibility requirements.
- All studies are conducted as per the institutional review board (IRB)
approved protocol, updated SOPs, current good clinical practice (GCP),
Good laboratory practice (GLP) standards and the Egyptian Drug
Authority (EDA) requirements.
- Bioanalytical methods are developed and validated in accordance with
the GLP rules and guidelines of FDA and EMA.
- Each activity is audited and verified by the Quality assurance (QA) unit
- FRC labs offer highly selective and sensitive assays of drugs and
metabolites using the latest high-performance liquid chromatography
(HPLC) and mass spectrometry (MS) techniques.
Biowaiver (BW) studies
- FRC has a fully equipped in-vitro unit for conducting comparative
- BW studies are conducted in accordance with the latest international
guidelines for biowaiver of bioequivalence studies based either on
biopharmaceutical classification system (BCS) or dose proportionality.
- FRC has a stability unit for conducting accelerated and long-term stability
studies for different dosage forms in compliance with the WHO and EDA
Trainings & Internships
- FRC provides effective learning and development opportunities through
organizing & conducting trainings & internships to fresh Pharmacy &
science graduates and senior students in the field of bioequivalence,
biostatistics & research activities.
Trainees are provided a training certificate at the end of their training period Click here to fill the application form.
- FRC experts offer formulation consultation to pharmaceutical companies
during the development and production of the dosage form to achieve the
desired quality of the product.
In Vitro Permeation Testing (IVPT)
IVPT is used in topical generic drug development as an accepted method of comparison to brand product. FRC can help pharmaceuticals screen and select actives with optimal penetration properties, characterize the skin distribution of active ingredients, quantify which formulation delivers the drug to its target skin layer and compare the optimized formulation to marketed products using Franz diffusion cells.