Pharmacokinetics and Biostatistical Data Analysis

Phase I and Bioequivalence Consultancy Services

With more than 20 years experience in successfully running phase I, bioequivalence, bioavailability and non-inferiority clinical studies, our company PharmacoKinetics, lead by dr. József Balázsi, is specialised in providing pharmacokinetic and biostatistical data analysis for regulatory submission. We provide services and consultancy in pharmacokinetic related clinical study documentation development, review; study design and planning, deficiency letter answering, interpreting statistical data from a new product development point of view, CRO set up, SOPs reviews etc. PharmacoKinetics is an independent and experienced contract research organisation having all necessary scientific and regulatory knowledge to professionally support your team to achieve its objectives.

József Balázsi studied Pharmaceutical Sciences at the University of Medicine and Pharmacy in Targu-Mures, Romania. He has been involved for more than 20 years in running and evaluating bioequivalence, bioavailability and phase I clinical trials. Mr. Balázsi has worked in the pharmaceutical industry as New Product Development Director coordinating regulatory affairs, bioequivalence clinical trials, and research and development activities. During his career he set up three Bioequivalence CROs and conducted more than 150 bioequivalence and phase I studies. He has extensive experience in pharmacokinetics, biostatistical data analysis, data management, study planning and development. Currently he is an independent consultant supporting setting up phase I CROs, performing bioequivalence, bioavailability and phase I studies.