What Level of Bioanalytical Method Validation is Right for My Early Stage Drug Development Study? - AIT BioscienceAIT Bioscience

What Level of Bioanalytical Method Validation is Right for My Early Stage Drug Development Study?

During late phase drug discovery, everyone follows well established FDA bioanalytical method validation guidelines. However, opinions vary widely about what validation is necessary for early- to mid-phase studies. We are often asked by our clients:

  • “How robust do I need this assay to be?”
  • “At what point can I use this data to present to investors?”

 

To tackle these issues, the bioanalysis community has developed four levels of assay method validation and evaluation to characterize the rigor of assays (see Table 1). Sponsors should communicate with their CRO partner about the intended use of the bioanalytical data in order for the CRO to identify the best method.
Table 1. Level of rigor for the bioanalytical and immunogenicity methods and the stage of drug development for which they are most appropriate.

Method Level of Rigor Drug Development Stage
Validated ♦ ♦ ♦ ♦ Pre-clinical GLP and clinical development
Qualified (small molecule only) ♦ ♦ ♦ Any but most commonly during pre-clinical development or late drug discovery
Research ♦ ♦ Mid- to late drug discovery
Screening Early drug discovery

 

To learn more about which bioanalytical method development and validation assays your early-stage development small molecule and immunogenicity studies may require, please read our recent Contract Pharma article.

Need help determining the appropriate level of bioanalytical method development and validation for your research? Contact us to get started.

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Categories: LC-MS/MS Methods, Ligand Binding Assays (LBA), Partnerships.