This Certara white paper equips drug development professionals with a practical framework for understanding why front-loading CMC activities is one of the most effective strategies for reducing pipeline risk. Readers will learn how performing key CMC activities early — including thorough developability evaluation, formulation selection, and physicochemical characterization — can identify potential manufacturability and bioavailability challenges before they escalate into costly late-stage failures.
The white paper also explores how integrating CMC activities with physiologically based pharmacokinetic (PBPK) modeling enables virtual trials, supports regulatory biowaiver applications, and reduces trial-and-error approaches.
Focused specifically on orally administered small molecule drugs, this white paper offers best practices for building a proactive CMC strategy that strengthens cross-functional collaboration, improves go/no-go decision-making, and ultimately increases a drug candidate’s probability of reaching patients.
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