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.