Bioequivalence (comparative pharmacokinetic) studies of medicinal products
A bioequivalence study is a mandatory requirement for registering generic veterinary medicinal products on the EAEU market. It proves that the generic product fully matches the reference (originator) product in its pharmacokinetic properties. A successful bioequivalence study confirms that the generic product has the same safety and therapeutic efficacy.
Why us
For bioequivalence studies, Neurometrix draws on extensive experience in preclinical and clinical testing. Working with us gives you:
- Advanced analytical equipment: the laboratory uses 170 units of high-precision equipment, including high-performance liquid chromatography and mass spectrometry systems.
- Proven protocols: experience of more than 10,000 studies rules out methodological errors when planning crossover studies.
- Flawless documentation: final reports are prepared in strict accordance with Good Laboratory Practice (GLP) and Good Clinical Practice.
How we work
- Detailed study design and protocol preparation.
- Formation of homogeneous groups of animals and administration of the test dosage forms.
- Systematic blood sampling and precise laboratory analysis.
- Pharmacokinetic and statistical analysis with calculation of confidence intervals.
Cost
The total cost of a bioequivalence study is based on the technical requirements. The price depends on the number and species of animals, the number of sampling time points, the specifics of analytical method validation and the physicochemical properties of the substance. Send us a project description to get a preliminary estimate.
How to order
To get a quote and agree on the study design, contact Neurometrix specialists by phone at +7 903 613-00-79 or send a request to info@neirometrix.ru. We prepare a commercial proposal within two business days.