Pre-IND Planning for Biosimilar Development with Emphasis on Population PK

This white paper from Somru BioScience focuses on the importance of early pre-Investigational New Drug (pre-IND) planning for biosimilar development, with a strong emphasis on Population Pharmacokinetics (PopPK).

Key takeaways include:

• Importance of Pre-IND Planning: It’s a crucial foundational step for biosimilar development, establishing regulatory roadmaps, designing early clinical trials, aligning modeling strategies, and efficiently using resources.