Validation Challenges for Bioassays
November 3, 2020 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
Overview: Validation of test methods is a critical requirement for the drug development process. Bioassays are used to support biologics in the drug development process and in post-market analytical support. Unlike analytical test methods for small molecules, bioassays have unique requirements due to the variable nature of some critical components. Although some variability may be inherent, careful attention to setting appropriate limits and to robust qualification of critical components enhances the likelihood of success during validation.
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