Bioequivalence study
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Bioequivalence study

In most cases, the differences in the therapeutic efficacy of original and generic drugs containing the same medicinal substances depend on differences in their bioavailability. Bioavailability represents the amount or concentration of the drug or its active metabolites that enter the bloodstream. If two drugs show similar values of pharmacokinetic parameters, it is believed that they have the same bioavailability. The main pharmacokinetic parameters of bioavailability are the area under the curve “concentration / time” (AUC), peak concentration of the active substance in plasma (Cmax) and time to Cmax (Tmax).

Similarities of generic drug with the original drug are determined by conducting bioequivalence studies which compare the rate and completeness of absorption of the drug under study in relation to the original. It is believed that if the plasma “concentration / time” profiles of two compared drugs are equal, their therapeutic activity will be also equal.

A report on the bioequivalence study conducted in the Russian Federation is a mandatory document for the registration of generic drugs.

RDG has experience in organization and conduct of bioequivalence studies the results of which are accepted by expert organizations and the Ministry of Health for registration of generic medicines. Duration of the trial is 4-6 months from the initiation visit to the final report.

RDG services:

Project management

  • Preparation of proposals for the product (trial scale / timelines / budget)
  • Developing of control system
  • Preparation of trial documentation package
  • Insurance of patients, volunteers, investigators
  • Obtaining permission to conduct trial
  • Obtaining import permission medicinal products
  • Selection of clinical centers (feasibility)
  • Training of investigational site personnel
  • Pre-screening and screening of patients (based on own base of patients and volunteers)
  • Qualification visit
  • Execution of contracts, agreements
  • Organization and conduct of the study
  • Clinical monitoring
  • Archiving of trial documentation
  • Quality control at all stages of the trial


Preparation of trial documentation

  • Protocol
  • Case record form
  • Investigator’s brochure
  • Patients’ information sheet and informed consent form
  • Documentation on the transfer / storage of medicinal products
  • Other supporting documents of the trial


Laboratory investigations

  • Analysis of bio-samples in the trial
  • Validation of analytical methods


Data processing

  • Encryption of data
  • Import / export of results and laboratory data
  • Preparation of final report


Statistical analysis of data

  • •              Development of study design taking into consideration statistical significance
  • •              Determination of patient sampling size
  • •              Choice of statistical analysis
  • •              Data processing
  • •              Preparation of interim and final statistical analysis
  • •              Preparation of statistical reports
  • •              Archiving of data



  • Obtaining of permission for import
  • Preparation of documents for customs clearance
  • Customs clearance
  • Delivery and storage of drugs, biomaterials
  • Preparation of medicinal products for the trial (labeling, packaging, etc.)


The base for the bioequivalence studies are the guidelines approved in the Russian Federation, and the guidelines for the studies approved in the European Union.


Estimated costs for bioequivalence study: from 1 000 000 rubles , depend on the number of volunteers, hospital days, frequency of blood sampling, number of endpoints, etc.