Drug development is a high-risk enterprise. The typical new drug takes 10-12 years to get to market and costs up to $500 million. Pharmaceutical companies face continually increasing challenges in drug development—shorter product life cycles, global competition, as well as daunting technical and regulatory hurdles. Meanwhile, as a result of the Human Genome Project and high throughput drug development methods, there are many more drug candidates to test. The drug screening process is increasingly difficult and important, so there is growing pressure on pharmaceutical and biopharm companies to be efficient in their drug discovery and development programs.

Roughly 80% of candidate drugs will fail during the preclinical phase of their development. A well thought out preclinical pharmacology/toxicology program is critical for the long-term effectiveness of a drug development effort. Because it helps drug developers avoid clinical trials that are destined to fail, it can be a major tool for reducing drug development costs.

Bringing a new drug product to market requires a good understanding of the drug development process and the integral role preclinical testing plays in that process. By properly addressing the critical steps in the development and approval process, you can avoid unnecessary expenses and barriers in getting your drug to market.

Download printable version of our booklet Preclinical Toxicology - Points to Consider in Program Design (PDF).