BIOAVAILABILITY AND BIOEQUIVALENCE IN DRUG DEVELOPMENT: CURRENT INSIGHTS AND FUTURE PERSPECTIVES

Loukik Kumar Madipalli*

ABSTRACT

Bioavailability and bioequivalence are pivotal concepts in pharmaceutical research, playing a crucial role in ensuring the safety, efficacy, and interchangeability of drug products. This paper presents a comprehensive review of the current insights and future perspectives surrounding bioavailability and bioequivalence in the context of drug development. The introduction provides a foundational understanding of these concepts, elucidating the significance of bioavailability as a determinant of drug action and the critical role of bioequivalence in evaluating generic drug products. Factors influencing bioavailability, encompassing physiological, formulation-related, and administration route variations, are thoroughly examined. The methods employed to assess bioavailability, both in vitro and in vivo, are explored, with a focus on key pharmacokinetic parameters. Advancements in biopharmaceutical modeling, simulation, and biorelevant dissolution testing are presented as emerging trends with the potential to refine bioavailability predictions. The incorporation of physiologically-based pharmacokinetic modeling is showcased as a promising approach to enhance bioavailability estimation. This review paper encapsulates the current state of knowledge regarding bioavailability and bioequivalence in drug development. It emphasizes the dynamic nature of these concepts, highlighting the ever-evolving methodologies, regulations, and technologies that shape their application. The insights presented herein provide a foundation for researchers, clinicians, regulators, and industry stakeholders to navigate the intricate landscape of bioavailability and bioequivalence, driving the field toward safer, more effective, and innovative drug development practices in the future.

Keywords: Bioavailability, Bioequivalence, Drug development, Pharmacokinetics, Generic drugs, Regulatory guidelines, Biopharmaceutical modeling.