Development and validation of bioanalytical methods

During the laboratory stage of preclinical studies, we develop an analytical method for determining the active substance and/or its metabolites in biological material. To prove experimentally that the method is fit for its intended purpose, we validate it. The main validation parameters for HPLC methods are system suitability, specificity, analytical range, linearity, accuracy, repeatability, intermediate precision, robustness and stability of working solutions. Defining the validation criteria is essential, since each validated parameter must conclude whether it meets the criteria. This requires in-depth knowledge of analytical methods, the specifics of the substances studied and the sensitivity of the instruments and detectors used.

A GLP-compliant quality system at every stage of preclinical studies, from sampling to statistical analysis, reduces the risk of unreliable results and repeat testing.

Work stages: from idea to report

We take care of the entire research process and minimise your workload:

• Study design: development of the design and work plan based on the specifics of your product and the requirements of the regulatory documentation.
• Model preparation: formation of test and control groups of animals and selection of optimal doses.
• Experiment: strict adherence to the study plan, monitoring of the animals and collection of biological samples.
• Laboratory analysis: testing of the samples (serum/plasma, tissues, organs, animal products) on modern equipment.
• Statistical analysis: professional analysis of the data obtained.
• Reporting: a final report ready for submission to the registration authorities.

Why choose us

• Compliance with standards: we work in accordance with GLP (Good Laboratory Practice), the OECD test guidelines and EAEU legislation on the registration of veterinary medicinal products. This ensures that preclinical data are accepted by regulators without additional requests or repeat studies.
• In-house facilities: modern analytical equipment lets us control every stage of the study within the company.
• Experience with different species: from laboratory rodents to food-producing and target species, we take species-specific metabolism and physiology into account when designing the study and interpreting the results.
• Transparent reporting at every stage: the client receives interim data during the study, not just the final report, and can adjust the next steps of the project if necessary.
• Expert support: our specialists help you design the study correctly at the planning stage to avoid problems at registration.

Need advice on the design of preclinical studies? Contact us to discuss your project. We will help you choose the optimal study strategy for a successful product launch.

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.

Frequently asked questions