Determining the similarity of a biosimilar to the innovator requires the measurement of both the biosimilar and innovator product in biological matrices for assessment of pharmacokinetic parameters. Somru BioScience offers high quality, sensitive and robust off-the- shelf ELISA kits for the measurement of drugs in biological matrices to support pharmacokinetic studies in both pre-clinical and clinical studies. Our assays are designed to minimize the effect of different biological matrices on the performance of the assay while maintaining appropriate levels of sensitivity.
All of our kits have been developed with the long term specific pharmacokinetic validation guidelines in mind. Our kits are easily adaptable to meet global regulatory guidelines on bioanalytical method validation (e.g. the FDA’s Guidance for Industry: Bioanalytical Method Validation, the EMA’s Guideline on bioanalytical method validation).
Our scientists have extensive experience and expertise in developing immunoassays in various platforms to support pharmacokinetic studies. In addition to our off-the- shelf immunoassays, we can develop custom assays to meet your needs. Please contact us at email@example.com to inquire about your custom assay development need.