Strategic Consideration to Leverage the Translatability From Preclinical Assessments to Clinical Trial Through Implementation of Appropriate Assays
Time: 9:00 am
day: Day Two
Details:
- In vitro cytokine release assay in hPBMC and in vivo toxicity assessment with characterization of drug exposure
- Immune response under repeated dosing modality of PEGylated LNP through systemic delivery and mitigation strategies
- Regulatory perspective of toxicity assessment on the LNP with different API entities
