Review of in vivo Bioequivalence Assessment and Pharmaceutical Development in Antimicrobial Drug Research

The pharmaceutical development and bioequivalence assessment of antimicrobial drugs play a crucial role in ensuring therapeutic efficacy, safety, and quality in clinical practice. This review explores current methodologies, regulatory frameworks, and scientific advances in the evaluation of antimicrobial formulations and their bioequivalence with reference products. It highlights the importance of bioavailability studies, pharmacokinetic profiling, and in vitro dissolution testing in establishing therapeutic equivalence, particularly in the context of generic drug development. The paper also discusses key challenges associated with antimicrobial agents, such as variable absorption, resistance development, and formulation stability, which can significantly influence bioequivalence outcomes. Regulatory agencies such as the FDA and EMA have developed stringent guidelines to standardize the approval process of antimicrobial generics, ensuring consistent therapeutic performance and minimizing resistance risks. Furthermore, emerging technologies, including nano carriers, advanced drug delivery systems, and biopharmaceutical modeling, are reshaping formulation strategies and bioequivalence testing approaches. Overall, this review provides an integrated perspective on the scientific and regulatory dimensions of antimicrobial drug development, emphasizing the need for continuous innovation and harmonization to support global access to effective, high-quality antimicrobial therapies.