NorthEast BioLab is a bioanalytical lab offering small and large molecule bioanalysis for clinical, preclinical, and drug discovery studies. Our team has an excellent track record of advancing Pharmacokinetics (PK), Bioavailability and Bioequivalence (BA/BE), Toxicokinetics (TK), Immunogenicity (ADA), Biomarker Testing, and Custom Assays. We offer Method Development and Validation using LC-MS/MS, ELISA, MSD ECL, Luminex Multiplex, Western Blot, and qPCR among other technologies. NorthEast BioLab is a full-service bioanalytical lab providing small and large molecule bioanalysis for clinical, preclinical, and drug discovery studies. We offer Method Development and Validation using LC-MS/MS, ELISA, MSD ECL, Luminex Multiplex, Western Blot and qPCR among other technologies. Our facility is GLP/GCLP compliant, FDA audited and DEA & CT State Schedule II-IV approved. Our team has an excellent track record of advancing Pharmacokinetics, Bioavailability, Bioequivalence, Toxicokinetics and Immunogenicity. We offer Method Development and Validation using LC-MS/MS, ELISA, MSD ECL and Luminex Multiplex technologies. We are a GLP/GCLP compliant, FDA audited, and DEA & CT State Schedule II-IV approved facility.
The dedicated team at NorthEast BioLab works with clients to develop custom bioanalytical laboratory services methods, or to adapt existing assays to their needs. We understand the need for high quality, reliable data, and we believe that a successful study is only possible through effective Method Development and Validation. This is why we perform 100% of the testing in-house, under the oversight of qualified scientists and Registered Analytical Chemists (RCA).
Bioanalysis method validation is the process of ensuring that the analytical procedure used for drug analysis is suitable for its intended purpose. A good method validation process will test several parameters such as calibration range, linearity, and accuracy and precision, robustness, specificity, and process stability of the analyte. Method validation is a process that validates the analytical procedure used for drug analysis in your preclinical and clinical studies. FDA bioanalysis method validation guidance for industry provides a set of standards to follow to ensure accurate measurements and test results.
Bioanalysis method validation is the part of the analytical process that establishes that the procedure is suitable for its intended use. It can be done before or after product release and should follow a rigourous protocol to ensure analytical accuracy and reproducibility, which are important factors in measuring drug concentrations and determining the concentration-response relationship. Biota’s bioanalysis method validation services cover everything from the development of new methods and procedures to providing data in support of regulatory submissions. We analyze method performance, determine analytical workflows and methodologies, as well as recommend suitable equipment for the project. We conduct both analytical performance studies and process validation for routine or emergency testing needs. Our in-house capabilities include mass spectrometry, immunoassays, chromatography and other analytical methods to provide comprehensive services from feasibility studies through process validation.
Method validation is a process that ensures that the analytical procedure and equipment used for drug analysis are suitable for their intended use. Method validation is mandatory with the FDA, and many other regulatory agencies require method validation prior to performing preclinical and clinical studies. The first step in bioanalysis is determining whether your analytical method is fit for purpose. This means that you need to confirm whether the analytical procedure used for drug analysis is suitable for its intended use. Accuracy, precision and sometimes ruggedness are important factors that should be addressed in a validation plan.