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Abstract
Emerging small molecule modalities present recurring bioanalytical challenges such as instability and poor recovery.
- Seven modality types were identified that pose specific bioanalytical challenges.
- Common issues include instability, poor recovery, matrix effects, and anti-drug antibody interference.
- Preliminary mitigation strategies were collected based on cross-company experiences and discussions.
- These strategies are potential approaches rather than formal recommendations.
- Early cross-functional assessment and modality-specific analytical strategies may be necessary for effective data use.
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