What is the first step in the new drug development process?

The first step in the new drug development process is pre-clinical testing in animals. This phase is essential because it involves rigorous experimentation to evaluate the safety, efficacy, and pharmacokinetic properties of a new drug candidate before it can be tested in humans. During pre-clinical testing, researchers often conduct a variety of studies, including toxicity tests, pharmacological testing, and formulation development, using animal models to assess how the drug behaves in a living organism.

This phase is crucial for identifying any potential risks or side effects that could arise during human trials, helping to ensure the safety of participants in the subsequent phases of clinical development. Only after successful pre-clinical testing can a drug developer move forward to file an Investigational New Drug (IND) application, which is necessary to initiate clinical trials in humans. The progression from pre-clinical testing to clinical trials is a key step in the regulatory pathway to bringing a new drug to market. Understanding this foundational step emphasizes the importance of thorough testing and research before advancing to more complex regulatory and clinical processes.