Offering extensive experience in the field of bioequivalence studies from project design and documentation, through clinical and bioanalytical work complete with full statistical clinical reports.
In pharmacokinetics, the term bioequivalence is used to assess the expected in-vivo biological equivalence of two different versions of a drug, where one of them is usually commercially available and is used as a reference drug.
If two products are said to be bioequivalent it’s expected that their behavior in the human body is, for all intents and purposes, the same.
The World Health Organization generally considers two formulations to be bioequivalent if a 90% confidence interval for the ratio of the generic/ tested product lies within an 80.00-125.00% acceptance range for the two observed parameters (AUC0-t and cmax).
For high-variable finished pharmaceutical products, the applicable acceptance range for the cmax parameter can be widened, or in cases of narrow therapeutic drugs, tightened.
Offering extensive experience in the field of bioequivalence studies from project design and documentation, through clinical and bioanalytical work complete with full statistical clinical reports, the QUINTA-ANALYTICA team comprises of multiple highly experienced principal investigators who are specialists in fields spanning internal medicine, cardiology, oncology, and pharmacology.
Ready to conduct your BE study? Get in touch with us today and discover your true pharma partner, QUINTA-ANALYTICA.
18 July 2023
Challenges of a large-scale study of breast cancer
Our bioanalytical experts and a high-profile client team up for the development of a new therapy for breast cancer.
29 June 2023
EU funding for Quinta-Analytica laboratory in Brno (CZ) was succesfully completed.
After two years, the project to finance new equipment for the Quinta-Analytica laboratory in Brno was successfully completed. The investment from European Regional Development Fund was used in this project.
22 June 2023
Quinta Analytica Partners with EvidentIQ to Enhance Efficiency of Phase 1 Studies
EvidentIQ partners with Quinta-Analytica to enhance Phase 1 study efficiency