PharmaPrimes provides integrated clinical and bioanalytical support for bioequivalence and bioavailability studies, combining clinical study execution, bioanalytical method development and validation, regulated sample analysis, pharmacokinetic evaluation, and study reporting.
Clinical conduct through the PharmaPrimes Clinical Research Center at Jordan Hospital.
Methods developed for the analyte, matrix, and required sensitivity of the study.
Validation according to applicable ICH M10 requirements.
Regulated analysis of clinical study samples.
Evaluation of PK parameters to support BE/BA conclusions.
Organized study data supporting analysis and reporting.
Study reports prepared to support regulatory submission.
PBPK/PBBM modeling and Virtual Bioequivalence simulations can support the design and optimization of BE studies, evaluation of formulation changes, and troubleshooting of bioequivalence failures.
Hospital-based clinical research through the PharmaPrimes Clinical Research Center located within Jordan Hospital in Amman.
Bioanalytical support for small molecules, peptides, therapeutic proteins, monoclonal antibodies, and biologics across preclinical, clinical, bioequivalence, and biosimilar programs.
Model-Informed Drug Development using PBPK/PBBM modeling and Virtual Bioequivalence simulations.
Discuss your product, reference product, and study design with our clinical and bioanalytical teams.
