Assay Qualification & Validation

Validation of analytical methods is primarily concerned with the identification of sources of potential errors and the quantification of these errors. BSSI statisticians are well versed in the requirements set forth in the United States Pharmacopeial Convention (USP) and the International Conference on Harmonization (ICH) guidelines regarding the qualification and validation of biological assays and can provide the following support:

  • Sample size review to meet regulatory requirements
  • Design of experiment (DOE)
  • Drafting/review of statistical methods sections for Validation Protocol
  • Analysis of validation parameters following USP & ICH guidelines
  • Statistical analysis plan (SAP) and statistical analysis report (SAR) preparation
  • Draft/review statistical sections of submission packages; draft/review responses to regulatory requests for information (RFIs); participate in regulatory meetings

BSSI statisticians have experience in the following non-exhaustive list of assays:

  • Enzyme-linked immunosorbent assay (ELISA)
  • High performance liquid chromatography (HPLC) assay
  • Potency assay
  • Enzyme-linked immunoSpot (ELISPOT) assay
  • Hemagglutination Inhibition (HAI) assay
  • Neutralization assay