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Services

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

      Expertise

      • Liquid Chromatography Mass Spectrometry
        • Mass Spectrometric Analysis
        • HPLC Method Development Validation
      • ELISA Assay
        • MSD ECL Assay
          • Luminex Multiplex Assay
            • LI-COR Odyssey Assay
              • PK PD Analysis
                • Method Development, Validation, and Transfer
                  • Method Development
                  • Method Transfer
                  • Method Validation
                  • Analytical Quantitation

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                                                          • Validation Of Chromatographic Methods (1994)

                                                          FDA Reviewer Guidance, Validation of Chromatographic Methods (1994)

                                                          Retrieved From
                                                          https://www.fda.gov/regulatory-information/search-fda-guidance-documents/reviewer-guidance-validation-chromatographic-methods

                                                          Services

                                                          • Pharmacokinetics (PK) Study
                                                          • Toxicology (Tox) Study
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                                                          • Bioequivalence and Bioavailability Studies
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                                                          Expertise

                                                          • Liquid Chromatography Mass Spectrometry
                                                          • ELISA Assay
                                                          • MSD ECL Assay
                                                          • Luminex Multiplex Assay
                                                          • LI-COR Odyssey Assay
                                                          • PK PD Analysis
                                                          • Method Development Validation and Transfer

                                                          Solutions

                                                          • Bioanalysis
                                                          • Clinical CRO
                                                          • Preclinical CRO
                                                          • Analytical Testing
                                                          • GLP Laboratory
                                                          • Non-GLP Testing

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                                                          • Overview
                                                          • Why Us?
                                                          • Values
                                                          • Leadership
                                                          • Therapeutic Areas
                                                          • Process
                                                          • Partners
                                                          • Facility and Equipment
                                                          • Quality and Compliance
                                                          • Careers

                                                          Resources

                                                          • Learning Center
                                                          • Blog
                                                          • Case Study
                                                          • News and Events
                                                          • Testimonials
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