Applied Drug Research, Clinical Trials and Regulatory Affairs - Current Issue

This article presents a comprehensive and comparative analysis of the regulatory frameworks governing the approval of pharmaceuticals in the Dominican Republic, Ecuador, and Nicaragua. It delves into the intricate scientific terminology and complex procedures inherent in these regulatory systems, shedding light on the demanding requirements that pharmaceutical companies must fulfil to secure market access in these co Read More

BackgroundThe normal metabolic functioning of aerobic cells is related to free radical formation. The oxygen utilized in the cell growth gives rise to a number of oxygen free radicals. Further, these oxygen free radicals interact with lipidic molecules to produce hydroxyperoxides and various other peroxides also, radicals like superoxide, hydroxyls, and lipoid peroxides, which lead to cytotoxicity due to their interaction with biological Read More

Treatment of complicated fatal diseases was difficult when nanotechnology was not more popular. The incorporation of nanomedicine has increased in the last 13 years, even though regulatory guidelines regarding nanomaterials and nanomedicine weren't sufficient. Hence, it was tough to decide valid inevitability for the manufacturers, administrators, health professionals, primary care providers, and rest of the public th Read More

Cell and gene therapy, offering unprecedented solutions for complex diseases, have attracted significant attention in both the scientific and financial communities. This article 
explores the tumultuous financial journey of companies specializing in these advanced therapeutic modalities. The discussion illuminates the volatility of share prices, challenges in 
valuation, and complexities in fundraising while delving into the inh Read More

Introduction and ObjectiveIndia's pharmaceutical industry faces challenges in meeting USFDA quality standards, impacting exports and reputation. This review examines the causes of non-compliance and proposes strategies to enhance compliance, predicting future trends.MethodsThis study conducts an analysis of USFDA warning letters to Indian manufacturers, an assessment of non-compliance issues, and an exploration of Read More