At first glance, both aim to understand safety. But their roles in drug development are fundamentally different. Non-GLP tox is about learning • Early-stage, flexible, hypothesis-driven • Helps define dose range, target organs, and study design • Fast and cost-effective, but not suitable for regulatory submission GLP tox is about proving • Conducted under strict regulatory standards (documentation, QA, traceability) • Generates data for IND/CTA submissions • Less flexible, more expensive—but fully auditable and accepted by regulators Briefly said, Non-GLP studies guide decisions, GLP studies justify them. Getting the transition right between the two is often what determines whether a program moves forward smoothly—or stalls.

If the doses are too low, you may see no adverse effects and falsely conclude the compound is safe—missing critical signals that would appear at slightly higher exposure. On the other hand, if doses are too high, you can trigger non-specific or exaggerated toxicity that isn’t relevant to clinical use, leading to misleading conclusions or even unnecessary program termination. This mistake is so impactful because early tox studies set the foundation for everything that follows: • dose selection for GLP studies • identification of target organs • definition of safety margins • and ultimately first-in-human starting doses A poorly selected dose range doesn’t just waste one study—it can distort the entire development strategy. In practice, getting this right requires: • integrating PK/PD data early • using range-finding studies intelligently • and maintaining flexibility to adjust based on emerging data

BIO International Convention is a key global platform for networking, partnerships, and innovation in the life sciences sector. For a preclinical CRO like MediTox s.r.o., it provides valuable opportunities to connect with biotech and pharmaceutical companies, showcase expertise in toxicology and safety studies, and establish strategic collaborations that drive business growth and international visibility. MediTox s.r.o. will be proud to participate in this prestigious event this year and looks forward to meeting partners and clients in person.