What Are The Benefits Of A Well-Designed, Robust Preclinical Development Plan?

By Felicity Grzemski, PhD, DABT

Drug development is a pricy, intricate, and regulated process that must always be treated with care and attention to detail. The disconnect between preclinical research and clinical development, where the translation has a success rate of less than 10%, is just one potential problem with early drug development. Poor drug-like properties, a lack of strategic planning, commercial necessity, and poor clinical efficacy and safety, which are typically investigated with preclinical pharmacology and toxicology studies, can also cause attrition.

When working to optimize a clinical study design, a well-designed preclinical plan and proper resource allocation can go a long way, often leading to cost savings and faster development timelines. Efforts placed into these study aspects can also help facilitate regulatory approval and mitigate regulatory risks.

Access the article to discover how a clever and robust preclinical development plan can help identify potential safety and efficacy issues early in drug development processes, ultimately reducing the risk of failure in clinical trials.