Before a potential new drug can be tested in humans, it must undergo rigorous preclinical research. This episode explores the crucial role of these studies, both in the lab (in vitro) and in living organisms (in vivo), in assessing a drug candidate's safety and efficacy. Discover how scientists use a variety of tests to evaluate a drug's properties, from its solubility and stability to its interactions with target molecules and potential toxicity. We'll delve into the ethical considerations surrounding animal research, highlighting the strict guidelines and regulations that are in place to ensure animal welfare.

Learn how preclinical studies help de-risk a compound, gathering crucial data that informs the design of future clinical trials. We'll also discuss the importance of Quality by Design (QbD) principles in preclinical research, emphasizing how a proactive approach to quality management can help minimize risks and maximize the chances of success. This episode provides a comprehensive overview of the preclinical phase, revealing the meticulous work that goes into preparing a drug candidate for human testing.