Brochures Overview
Based on the FDA, ICH, and CDE guidelines for vaccines, gene therapies, pharmaceutical excipients, and adjuvants, the DMPK Service Department of WuXi AppTec has comprehensively summarized the pharmacokinetic study designs and research methodologies employed for mRNA-based vaccines and therapeutics in the clinical stage and market. The result is a detailed interpretation on the preclinical pharmacokinetic data of FDA-approved mRNA vaccines. Substantial differences in the mechanisms of action and molecular types have led to distinct evaluation objectives and requirements in their preclinical pharmacokinetic study. Therefore, tailored pharmacokinetic research strategies are essential to address these specific needs.
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