Transformative Paths: Preclinical Drug Formulation and Delivery Approaches in Development

Abstract

This comprehensive review explores the multifaceted landscape of preclinical drug development, encompassing crucial stages, regulatory intricacies, Investigational New Drug (IND) submissions, and innovative formulation strategies. Delving into preclinical studies, the review underscores the importance of pharmacokinetics, pharmacodynamics, and safety assessments in animal models. Regulatory requirements governing preclinical studies are dissected, emphasizing compliance with global health authorities. The article provides a detailed examination of the IND submission process, elucidating essential components and documentation required for regulatory approval that are pivotal for advancing to clinical trials. Additionally, the evolving realm of Preformulation strategies is scrutinized, highlighting new methods like nanotechnology, solid dispersions, and formulas based on cyclodextrin to enhance drug solubility, stability, and bioavailability. This comprehensive overview aims to guide researchers, pharmaceutical professionals, and regulatory specialists through the complexities of preclinical development, offering insights into the latest formulation advancements from a legal point of view, making it be easy for potential drugs to go from lab to patient's bedside.

Keywords: IND; Pre-clinical studies; formulation strategies; innovation; pre-formulation studies; regulatory approval..