Learn how to validate your program strategy before initiating studies to ensure success.

Understand the critical CMC considerations required before commencing non-GLP and GLP studies.

Discover how to effectively manage supporting studies like PK, safety pharmacology, and genotoxicity to enhance your toxicology program.

About the Checklist

This comprehensive guide provides invaluable insights for scientists, project managers, biotech founders, and drug development professionals planning or overseeing IND-enabling toxicology programs. Learn how to sequence non-GLP studies correctly, ensure test article readiness, select the right CRO, and much more to streamline your toxicology program effectively.

About the Creator

Hi, I'm Dessi McEntee, MS, DABT — a board-certified toxicologist with over a decade of experience leading nonclinical programs across biotech and pharmaceutical development. I wrote this book after watching talented teams struggle not because of bad science, but because no one had given them a framework for turning data into decisions. My goal is simple: to give you the strategic clarity that typically takes senior professionals years to develop — so you can lead with confidence, defend your programs, and stop letting data substitute for judgment.

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