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Bioequivalence study

Bioequivalence study

Bioequivalence (PHARMACOKINETIC EQUIVALENCE) – the degree of similarity of a pharmaceutically equivalent drug to a reference product. It is determined experimentally, in vivo. The main BE criteria – extent and rate of drug absorption, time to achieve the maximum blood concentration and its values, type of a drug distribution in body tissues and fluids, type and rate of a drug elimination. .

Services:

   

  • Development of phase I study protocols;
  • Development of supporting documents (protocol, investigator’s brochure, patient informed consent, paper and electronic CRF)
  • Selection of a clinical base for BE studies (Presence of own clinical base certa-clinic (link to the company site) for BE studies)
  • Insurance of volunteers participating in BE studies
  • Obtaining of approval for BE study
  • Arrangement, monitoring, data management and statistical processing of BE study results
  • Preparation of the final report on BE studies

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