Today most medicines at Ukrainian pharmaceutical market are generics. There is no doubt that generics should meet the same standards of quality, effectiveness and safety as original drugs.
An evidence of interchangeability with the original medicine is a requirement for marketing registration of any generic drug. Proven bioequivalence is a guarantee of equivalent therapeutic effect and safety of generic compared to original medicine.
Therefore bioequivalence studies have important economic and clinical significance.
Clinical and Diagnostics Center of the National University of Pharmacy provides a wide range of services for introduction of your generic drug into the pharmaceutical market. Unique experience of our specialists and appropriate resource as well as technical base allow our clients to run bioequivalence study as soon as possible and in strict accordance with the GCP requirements and guidelines issued by Ministry of Health of Ukraine, EMA, FDA.
Our services on conducting bioequivalence studies include the following:
- elaboration of bioequivalence study design and required documentation;
- recruitment of healthy volunteers for bioequivalence study;
- carrying out the study in strict accordance with the study protocol;
- organizing the transportation of biological specimens to the pharmacokinetic laboratory;
- storage of archival biological specimens;
- final report on bioequivalence study in accordance with international and local requirements.
Useful link:Phase I Clinical Trial