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Expertise

  • All Expertise
    • Liquid Chromatography Mass Spectrometry
      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
      • Luminex Multiplex Assay
    • Meso Scale Discovery Assay
      • LI-COR Odyssey Assay
        • Method Development, Validation, and Transfer
          • Method Validation
          • Method Development
          • Method Transfer

        Services

        • All Services
          • Pharmacokinetics (PK) Study
            • Toxicology (Tox) Study
            • Bioequivalence and Bioavailability Studies
            • PK PD Analysis
            • Dose Formulation Analysis
            • Drug Metabolism and Pharmacokinetics (DMPK)
            • ADME Studies
          • ADA Assay Immunogenicity Testing
            • Biomarker Testing Services
              • Biomarker Assay List
            • Bioanalytical Assay
              • Biochemical Assay
              • Mechanism of Action (MOA) Studies
              • Cell-based Assays
              • Cytotoxicity Assay

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                    About Us

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                                          • GLP Quality Assurance Manager, Bioanalytical Lab
                                          • Sr. Scientist, ELISA Immunoassay Bioanalysis
                                          • Sr. Scientist, LC-MS/MS Bioanalysis – Hamden, CT, USA
                                          • Associate Scientist, Central Laboratory Services
                                          • Sr. Scientist - Pharmacokinetics (PK) Studies
                                          • Content Manager, Scientific and Regulatory Writing

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                                                      • FDA Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (2012)

                                                      FDA S6(R1) Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (2012)

                                                      Retrieved From
                                                      https://www.fda.gov/regulatory-information/search-fda-guidance-documents/s6r1-preclinical-safety-evaluation-biotechnology-derived-pharmaceuticals

                                                      Expertise

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                                                      • Pharmacokinetics (PK) Study
                                                      • ADA Assay Immunogenicity Testing
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