Non-clinical studies
Abstract
Nonclinical studies play a crucial role in the drug development pathway, providing essential insights into the safety and potential effectiveness of drugs, biologics, and devices. These studies, which include both in vitro and in vivo experiments, are conducted in compliance with Good Laboratory Practices (GLP) and non-GLP standards, and are designed to define the relevant efficacy and/or safety characteristics of the products under development. Nonclinical development experts, such as those at ProPharma Group, provide critical guidance to sponsors, helping to ensure that nonclinical studies are appropriately designed and conducted to support the intended indication, route of administration, and duration of treatment. Nonclinical studies play a crucial role in the development of drugs, biologics, and devices by providing valuable insights into their safety profile and potential effectiveness. Conducting nonclinical evaluations throughout the product development process enables informed decision-making, risk assessment, and enhances confidence in the ultimate success of the clinical evaluations and regulatory approval. Nonclinical studies include pharmacology, pharmacokinetic, and toxicology programs that are appropriate to support the intended indication, route of administration and duration of treatment for the product. The nonclinical development program can help assure that time and resources are not spent on studies that fail to meet regulatory expectations.