Pharmaceutical Regulatory Affairs: Open Access

Virtual bioequivalence assessments have emerged as a valuable tool in the pharmaceutical industry, particularly for evaluating orally administered drugs. This approach leverages computational modeling and simulation to predict how different drug formulations compare to each other in terms of their pharmacokinetic profiles. The primary advantage of virtual bioequivalence is its potential to reduce the need for extensive in vivo testing, thereby accelerating drug development and lowering costs. However, ensuring the accuracy and reliability of these virtual assessments remains a challenge. This article explores current methodologies for virtual bioequivalence, discusses their benefits and limitations and proposes strategies for improving their efficacy. Advances in computational power, modeling techniques and integration of real-world data are highlighted as key factors that could enhance the precision of virtual bioequivalence evaluations.

The advent of messenger RNA (mRNA) therapeutics has revolutionized the field of medicine, particularly in the treatment of genetic disorders and infectious diseases. However, the complexity of mRNA molecules necessitates precise and reliable analytical techniques to ensure their efficacy and safety. Traditional chromatographic methods for mRNA analysis often fall short in terms of resolution and throughput. This article introduces a novel approach to mRNA analysis using ultra-wide pore Size Exclusion Chromatography (SEC) columns, which promise to enhance the precision of mRNA characterization. By expanding the pore size range of SEC columns, this technique improves the separation and quantification of mRNA molecules based on their size and conformation. This article discusses the principles behind ultra-wide pore SEC, compares it with conventional methods, and highlights its advantages in terms of resolution, reproducibility, and sensitivity. The implementation of these advanced columns can significantly advance mRNA therapeutics development and quality control.

The production of monoclonal antibodies (mAbs) has revolutionized medical treatments across human and veterinary fields, offering precise and effective therapies for a range of conditions. Traditional methods of mAb production involve mammalian cell lines, which, while effective, are costly and complex. Recent advancements in plant biotechnology have introduced a novel and cost-effective alternative: plant-based platforms for mAb production. This article explores the potential of harnessing plant platforms for the production of mAbs in veterinary medicine, detailing the mechanisms, advantages, and challenges associated with this innovative approach. Plant-based systems offer several benefits, including reduced production costs, enhanced safety profiles, and scalability. However, challenges such as regulatory hurdles and plant-specific glycosylation patterns must be addressed to fully realize their potential. This review aims to provide a comprehensive overview of current developments and future prospects in plant-based mAb production, emphasizing its implications for veterinary therapeutics.

Hydrophilic nanofibers have emerged as a promising platform for various biomedical applications, including drug delivery systems, wound healing, and tissue engineering. The incorporation of drugs into these nanofibers can significantly influence their physicochemical properties, affecting their performance and efficacy in practical applications. This article reviews the impact of drug incorporation on the properties of hydrophilic nanofibers, including changes in fiber morphology, mechanical strength, hydrophilicity, and drug release profiles. The review highlights the various methods used to incorporate drugs into nanofibers, such as electrospinning and solution blending, and their effects on the nanofiber's characteristics. Furthermore, it discusses the implications of these changes for drug delivery and other biomedical applications. Understanding these impacts is crucial for optimizing nanofiber-based systems for specific therapeutic needs.