Bioassay qualification and validation survey 2019

This blinded 'Members Only' survey designed and completed by 15 leading pharmaceutical companies, compares and draws conclusions on 62 different aspects on bioassay qualification and validation.


The survey assumes that qualification describes activities which demonstrate suitability of a method for use in early stages of product development while full method validation using a pre-approved protocol with acceptance criteria is performed prior to using a method for later stages of development and commercialization.Assay Qualification & Validation Definition.


The survey questions cover matters such as:

  • Guidelines do you use for your validation experimental design
  • Qualification parameters and levels used
  • Acceptance criteria
  • Personal and functions involved
  • Provision and preparation of samples
  • Potency levels and linearity considered
  • Use of DoE and QbD and how these change in development phases
  • Specification ranges
  • Re-validation

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