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Introduction to Bioequivalence Center

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  • Wednesday, 10 January 2018 12:01
Overview:
Bioequivalence center at MSA University is the first nationally recognized licensed BE Center at an Egyptian private university. - The Center is established and being administrated by a team of highly skilled scientists and staff from faculty of pharmacy, in addition to several nationalities well-known consultants. - The BE center is based on many years of academic experience and deep understanding of quality system which has been internationally acknowledged. - The center provides excellent and compassionate care to every volunteer through modern state of the art clinics, accommodating facilities and highly trained, dedicated staff while maintaining strict compliance with the top clinical practice.
Services provided:

*Bioequivalence studies

 

  • conducting a variety of BE study designs, including Cross-over, parallel, partial replicate, full replicate, fast and fed studies.
  • An effective system for recruiting that ensures the application of the strictest eligibility rules and has a large database of fit volunteers chosen through a thorough screening procedure
  • All research is carried out in accordance with the Egyptian Drug Authority (EDA) regulations, updated SOPs, good clinical practice (GCP), good laboratory practice (GLP), and protocols approved by the institutional review board (IRB).
  • The Quality Assurance (QA) unit audits and validates each action.
  • The MSA Bioequivalence Center employs the most recent advances in mass spectrometry (MS) and highperformance liquid chromatography (HPLC) to provide highly sensitive and selective drug and metabolite testing

 

*Biowaiver studies

 

MSA Bioequivalence center possesses a fully functional in vitro equipment for doing comparative dissolutions tests, investigations are carried out in compliance with the most recent international recommendations for biowaiver of bioequivalency studies, which are based either on dosage proportionality or the biopharmaceutical categorization system (BCS).

 

Our Location:

Inside MSA University Campus “26 July Mehwar Road intersection with Wahat Road, 6th October City. Egypt.”

Contact us:

Dr/Dina Karam

Center Manager

+0201129801960

 

Dr/ Aya Badr

Quality Assurance Manager

+0201112006907

 

Hotline : 16672

 

Mail us

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