Bioequivalence

PHARMBIOTEST offers comprehensive clinical trial services on Phase 1-4 clinical research trials with emphasis on pharmacokinetic, bioavailability and bioequivalence studies.

PHARMBIOTEST provides a full range of services for pharmacokinetic and bioequivalence studies

All procedures: study design planning, medical writing of study protocol, CRF / source data form design and other required documents, preparation of documents for regulatory submissions, ssubject recruitment, clinical conduct of the study, project and site management, analysis of PK samples, data management and statistical analysis, reporting of study results and archiving of all trial-related data are conducted in accordance with GCP/GLP guidelines.

Let us guide your study!

WHAT WE DO

BA/BE study

PHARMBIOTEST offers a full services of bioequivalence/pharmacokinetic studies.

Clinical Trial Documents Development

PHARMBIOTEST has experience in clinical trials and provides document development services for phase I-IV clinical trials.

Bioanalytical Services

PHARMBIOTEST bioanalytical laboratory provides services of quantifying ultra low concentrations of small and medium-sized organic molecules in biological samples in the course of preclinical  trials.

Biostatistics

PHARMBIOTEST provides statistical support of clinical trials (pharmacokinetic studies and bioequivalence studies, dose-proportionality, efficacy, tolerability, safety, etc.)

Our policy in quality management is founded on the established precepts of Good Clinical Practices (GCP) and Good Laboratory Practices (GLP) which are embedded in all spheres of our activity, processes and procedures.

Grygorii Tsapko,  Director