Bioequivalence Studies

Zi diligence has built a brand of excellence in the conduct of bioequivalence and bioaviability studies with more than 140 BE studies to support generic drug approval.

With trustworthy quality and reputable data in consideration, Zi Diligence team is trained and empowered to deliver its very best each and every day.

Bio-Analysis Services

Led by Dr Youmna Mosaad, a 11-year experience in Bioanalytical Research, the lab team at Zi-diligence appreciates the importance of delivering quality and innovative solutions to support the drug development programs of our clients.

Whether it’s combining the analysis of multiple compounds into a single assay (e.g. amlodipine/Olmesartan/hydrochlorothiazide) or utilizing a double extraction method to analyze drug products

Comparative Dissolution Services

Zi Diligence provides comparative dissolution services as biowavier and comparative in-vitro dissolution studies.

The selection of the dissolution specifications (conditions and acceptance criteria) for product release is determined according to international guidelines such as: USP, FDA, and Biopharmaceutics Classification System (BCS).

Pharmacokinetics & statistics

Understanding the basic PK and metabolism characteristics of the drug compound will eventually reveal the appropriate drug regimen for a patient.

The pharmacokinetic parameters of BE/BA studies are calculated using KINETICA 2000(Version 4), a proprietary software for BE studies. The pharmacokinetic/ statistical analysis is done according to FDA guidance.

Data Management

Of equal importance is the management of the data produced by the clinical research study. The precise, reliable and accurate collection of data organized and packaged to meet current regulatory and industry standards is imperative for every study.

Zi Diligence’s Data Management team is involved right from the outset to ensure that data is correctly managed every step of the way.

Medical Writing

Zi-diligence Medical Writing team provides a full suite of writing services having completed study documents for over 140 studies. This expert team collaborates with all departments (Medical, Clinical, Pharmacy, Regulatory Affairs, Biostatistics, Data Management, Project Management, Quality Assurance, and Bioanalysis)