sales@nebiolab.com Email Your Inquiry
(203) 361 3780 Speak to Our Scientists
NorthEast BioLab Agile Bioanalysis Services CRO
  • Expertise
    • All Expertise
    • Liquid Chromatography Mass Spectrometry
      • HPLC Method Development Validation
      • Mass Spectrometric Analysis
    • ELISA Method
    • MSD Assay
    • Luminex Multiplex Assay
    • LI-COR Odyssey Assay
    • PK PD Analysis
    • Method Development, Validation, and Transfer
      • Method Validation
      • Method Development
      • Method Transfer
  • Services
    • All 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
      • Biochemical Assay
      • Mechanism of Action (MOA) Studies
      • Cell-based Assays
      • Cytotoxicity Assay
  • Solutions
    • All Solutions
    • Bioanalysis
    • GLP Laboratory
    • Clinical CRO
      • Clinical Trial Sample Management and Storage
    • Preclinical CRO
    • Analytical Testing
      • Analytical Quantitation
    • Non-GLP Testing
      • Discovery and Research
      • Cosmetic Testing
  • About Us
    • About Us
    • Overview
    • Why Us?
    • Values
    • Leadership
    • Process
    • Quality and Compliance
    • Facility and Equipment
    • Therapeutic Areas
    • Partners
    • Careers
      • 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
  • Resources
    • Learning Center
    • Blog
    • Case Study
    • News and Events
    • Testimonials
    • Contact Us
  • Request Quote
NorthEast Biolab Agile Bioanalysis Services CRO Request Quote

Expertise

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

              Services

              • All 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
                      • Biochemical Assay
                      • Mechanism of Action (MOA) Studies
                      • Cell-based Assays
                      • Cytotoxicity Assay

                    Solutions

                    • All Solutions
                      • Bioanalysis
                        • GLP Laboratory
                          • Clinical CRO
                            • Clinical Trial Sample Management and Storage
                          • Preclinical CRO
                            • Analytical Testing
                              • Analytical Quantitation
                            • Non-GLP Testing
                              • Discovery and Research
                              • Cosmetic Testing

                            About Us

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

                                                Resources

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

                                                            Request Quote

                                                              Contact Us

                                                              • Home
                                                              • Bioanalytical Method Validation (2019)

                                                              FDA M10 Bioanalytical Method Validation (2019)

                                                              Retrieved From
                                                              https://www.fda.gov/regulatory-information/search-fda-guidance-documents/m10-bioanalytical-method-validation

                                                              Expertise

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

                                                              Services

                                                              • Pharmacokinetics (PK) Study
                                                              • Toxicology (Tox) Study
                                                              • Biomarker Testing Services
                                                              • Bioequivalence and Bioavailability Studies
                                                              • Immunogenicity Testing
                                                              • Bioanalytical Assay

                                                              Solutions

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

                                                              About Us

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

                                                              Resources

                                                              • Learning Center
                                                              • Blog
                                                              • Case Study
                                                              • News and Events
                                                              • Testimonials
                                                              • Contact Us
                                                              NorthEast BioLab Logo
                                                              925 Sherman Avenue Hamden, CT 06514
                                                              sales@nebiolab.com
                                                              (203) 361 3780

                                                              Consult with a Scientist Now

                                                              We Will Contact You Within 1 Business Day

                                                              • Good Laboratory Practice for Nonclinical Laboratory Studies
                                                              • Food and Drug Administration (FDA)
                                                              • United States Drug Enforcement Administration
                                                              • Connecticut State Department of Consumer Protection
                                                              • Privacy Policy
                                                              • Terms of Use
                                                              • Sitemap
                                                              © 2019 - 2025, NorthEast BioAnalytical Laboratories LLC. All rights reserved.

                                                              How Can We Help?

                                                              I agree to receive emails, calls, and messages, etc from NorthEast BioLab.

                                                              Before you go! Get
                                                              your FREE Download:

                                                              Top 7 Hidden Pitfalls to your Bioanalytical Milestones

                                                              Step by step guide on how to accelerate your drug approval

                                                              • Addressing Main Constraints
                                                              • Research Best Practices
                                                              • The Economic Advantage
                                                              • Critical Decision Marketing Mode Easy
                                                              • Legal Documentation Checklist
                                                              We won’t share your email, ever, See our privacy policy

                                                              No thanks, I don’t need to improve my drug approval process