Veterinary Bioequivalence & Generic Development

Veterinary Bioequivalence & Generic Development
A science-based pathway
for veterinary medicinal products

We support veterinary generic development through in vitro laboratory testing, in vivo pharmacokinetic studies and integrated analytical support. Each project begins with an assessment of the product and the applicable regulatory pathway.

REQUEST A STUDY PROPOSAL

What is bioequivalence?

Bioequivalence demonstrates that there is no relevant difference between a test and reference medicinal product in the rate and extent to which the active substance becomes available under comparable conditions. Depending on the product, bioequivalence may be demonstrated through an in vivo study or supported by pharmaceutical and in vitro data when the requirements for a biowaiver are fulfilled.

Selecting the appropriate pathway

In vitro testing and biowaiver support

For certain products, an in vivo study may be waived when equivalence can be adequately justified by pharmaceutical and in vitro data. Eligibility depends on the dosage form, active-substance properties, formulation, excipients and dissolution behaviour.

Comparative dissolution testing
Solubility and physicochemical characterisation
Assay and content uniformity testing
Analytical method development, validation and transfer

In vivo bioequivalence studies

When an in vivo comparison is required, bioequivalence is generally evaluated through a comparative pharmacokinetic study in the relevant animal species. The study design is adapted to the product, target species, route of administration and pharmacokinetic characteristics.

Protocol and sampling-schedule development
Animal dosing and clinical observation
Serial blood sampling and sample processing
Bioanalytical support
Pharmacokinetic and statistical evaluation
Comprehensive study reporting

Regulatory and quality framework

Projects are designed according to applicable regulatory guidance, including EMA/CVMP/016/2000-Rev.4 and VICH GL52, where relevant. The GLP status and allocation of responsibilities are defined clearly before project initiation and within the current scope of Tekrolab’s certifications.

Why Tekrolab?

Tekrolab has supported the development of numerous veterinary medicinal products and their registration in several EU Member States, providing integrated in vitro testing, in vivo pharmacokinetic studies and analytical support for bioequivalence and biowaiver pathways.

Experience gained through the development and registration of more than 45 veterinary medicinal products
Own animal testing facility and analytical laboratory
Integrated in vivo and in vitro capabilities
Experience with pharmacokinetic studies and intensive sampling
One project team from feasibility assessment to final report
Clear definition of GLP status, regulatory requirements and project responsibilities
Science-based selection of the most appropriate bioequivalence or biowaiver pathway
In-house development and validation of analytical and bioanalytical methods
Expert support throughout veterinary generic product development