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RESOURCES

Guidance

I. ICH Guideline M10 on Bioanalytical Method Validation Step 5 (ema.europa.eu)

II. M10 Bioanalytical Method Validation And Study Sample Analysis – Guidance for Industry (FDA, November 2022 ICH)

III. Bioanalytical Method Validation Guidance for Industry (FDA, May 2018)

IV. Immunogenicity Testing of Therapeutic Protein Products – Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry (FDA, January 2019)

White Paper

I.Recommendations on qPCR/ddPCR Assay Validation by GCC, Bioanalysis (2022) 14(12), 853–863

II.The MIQE Guidelines: Minimum Information for Publication of Quantitative Real-Time PCR Experiments. Clin. Chem. 55(4), 611–622 (2009)

III. The digital MIQE Guidelines Update: Minimum Information for Publication of Quantitative Digital PCR Experiments for 2020. Clin. Chem. 66(8), 1012–1029 (2020)

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Avantia Labs
206 Welsh Road
Horsham, PA 19044

  • 1-215-692-2637
  • Info@AvantiaLabs.com
  • www.avantialabs.com

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