By Mohan Krishnappa, Associate Research Director, Safety Assessment, Syngene International Ltd.
According to research, 85% of new drugs fail during clinical trials (Phase-1 to FDA approval). The reasons for failure include poor solubility, life-threatening or other undesirable side effects, poor biodistribution by the proposed clinical route of administration, poor efficacy in early clinical trials, and so on.
For a molecule to progress smoothly from early-stage discovery to the investigational new drug (IND) phase and further to successful clinical trials, the data from preclinical trials must be accurate, reliable, and based on the best suitable and comparable model available to the target population. This means the IND or drug product must undergo a series of robust tests and experiments as per the focused indication and regulatory guidelines (FDA/EMA etc.).
In this point of view, we discuss how Syngene’s expertise in In vivo Safety /Tox studies can help move your molecule from early discovery to IND stage successfully. With 27 years of scientific experience, working across 400+ global clients, we have been able to create a roadmap for IND-enabling preclinical studies, supported at each stage by a strong supply chain, logistics, program management, and data security.