Common Delays During the Preclinical Phase

Common Delays During the Preclinical Phase

Advancing a novel therapeutic from research and discovery to clinical trials and the market is an expensive and time-consuming process. Every failed candidate can cost the company money and their reputation. Therefore, it’s important to stay on track throughout the drug development pipeline. Preventing delays during the preclinical phase is particularly critical for success.

The number one cause of delays in preclinical research is issues with test article. A shortage of test article, and then having to wait while more is manufactured, significantly hinders progress. While it is difficult to approximate the amount of test article needed before having data on toxicity or efficacious dose levels, it is always better to over-estimate during production rather than end up with too little.  Additionally, test articles manufactured overseas commonly get caught up in Customs. Always ensure that your test article is accompanied by proper documentation and that it meets all import and export requirements.

Another factor that can influence the research timeline is selecting the appropriate test species for preclinical studies. The therapeutic being tested must be pharmacologically active in the chosen animal model. The species must also be relevant to humans as preclinical data is often used to extrapolate possible findings from clinical trials. Studies performed in a non-relevant species can end in misleading results. And even if the correct animal model is chosen, too few animals or a nondiverse group can alter the experimental outcomes. A large sample size should be used to obtain the most accurate results and prevent repeat studies that postpone progress.

Contact Us

6 + 12 =

Jackson Certified
Brooklyn-Irish Hills Chamber of Commerce logo

science exchange logo

scientist.com logo