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Expertise

  • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
      • Menu IconELISA Assay
        • Menu IconLuminex Multiplex Assay
      • Menu IconFlow Cytometry
        • Menu IconqPCR Analysis, ddPCR Assay
          • Menu IconWestern Blot, In Cell Western

            Services

            • Menu IconAll Services
              • Menu IconPharmacokinetics (PK) Study
                • Menu IconToxicology (Tox) Study
                • Menu IconDose Formulation Analysis
                • Menu IconPK PD Analysis
                • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
                • Menu IconADME Studies
                • Menu IconBioequivalence and Bioavailability Studies
              • Menu IconADA Assay, Neutralizing Antibody Assay
                • Menu IconMultiplex Cytokine Assay
                  • Menu IconBiomarker Assay
                    • Menu IconBiomarker Assay List
                  • Menu IconCell-Based Assay
                    • Menu IconMechanism of Action (MOA) Studies
                    • Menu IconCytotoxicity Assay
                    • Menu IconBiochemical Assay
                  • Menu IconBioanalytical Assay Validation

                    Solutions

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                      • Menu IconClinical CRO
                        • Menu IconCentral Lab Services
                        • Menu IconPBMC Services
                      • Menu IconGLP Laboratory
                        • Menu IconBioanalysis
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                      • Menu IconPreclinical CRO
                        • Menu IconMethod Development, Validation, And Transfer
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                          • Menu IconMethod Development
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                        • Menu IconAnalytical Testing
                          • Menu IconDiscovery Screening Services
                          • Menu IconAnalytical Quantitation
                          • Menu IconCosmetic Testing

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                                              • Menu IconBusiness Development Associate
                                              • Menu IconSr. Scientist – Cell Based Assay
                                              • Menu IconGLP Quality Assurance Manager
                                              • Menu IconSr. Scientist, ELISA Immunoassay Bioanalysis
                                              • Menu IconSr. Scientist, LC-MS/MS Bioanalysis
                                              • Menu IconAssociate Scientist, Central Laboratory Services
                                              • Menu IconSr. Scientist - Pharmacokinetics (PK)
                                              • Menu IconContent Manager, Scientific and Regulatory Writing

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                                                            • Home
                                                            • 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

                                                            Contact A Scientist With Your Bioanalytical Study Details

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                                                            Expertise

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • Flow Cytometry
                                                            • qPCR Analysis, ddPCR Assay
                                                            • Western Blot, In Cell Western

                                                            Services

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Multiplex Cytokine Assay
                                                            • Biomarker Assay
                                                            • Cell-Based Assay
                                                            • Bioanalytical Assay Validation

                                                            Solutions

                                                            Solutions

                                                            • Clinical CRO
                                                            • GLP Laboratory
                                                            • Preclinical CRO
                                                            • Method Development, Validation, And Transfer
                                                            • Analytical Testing

                                                            About Us

                                                            About Us

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

                                                            Resources

                                                            Resources

                                                            • Learning Center
                                                            • Blog
                                                            • Case Study
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
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