Systematic Review on Clinical Trial Regulations: Perspectives from India, USA, and Europe.

Introduction: The pharmaceutical industry has undergone significant regulatory evolution, particularly in India, with the replacement of Schedule Y by the New Drugs and Clinical Trial (NDCT) Rules. These changes reflect India's commitment to ensuring the efficacy, safety, and quality of drugs while aligning with global standards.

Methods: To conduct the literature search for the review, we employed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) approach from 2013 to 2024 for selecting titles and abstracts.

Comparative Review of Clinical Trial Regulations in Different Countries: Current Scenario and Future Prospect.

Introduction/objective: Clinical trial regulations (CTR) are essential for ensuring the safety, efficacy, and ethical conduct of drug development. However, the regulatory frameworks governing these trials vary significantly across different countries, affecting approval processes, trial conduct, and drug development timelines. This review examines the differences in clinical trial regulations in the USA, EU, Australia, and India between 2016 and 2024.

A Review of Software in Clinical Trials: FDA Regulatory Frameworks and Addressing Challenges.

An essential tool for assessing the efficacy and safety of novel therapies and interventions is the clinical trial. They are crucial for understanding disease causes, treatment effectiveness, and patient care processes. However, traditional clinical trials often suffer from inefficiencies, high costs, and extended timelines.

Biosimilar Regulations: Current Framework and Future Prospects.

Introduction/objective: Biosimilars, a class of biologic medications that are highly similar to reference biologics, have emerged as cost-effective alternatives to their expensive originator counterparts. Due to their complex nature and manufacturing processes, biosimilars differ significantly from small molecule generics and must undergo a rigorous assessment to ensure safety, efficacy, and accessibility. This review explores the regulatory landscape surrounding biosimilars across key markets such as the United States, Europe, and India, with a focus on approval processes and post-marketing pharmacovigilance for patient safety.

Physical Characterization and In Vitro Evaluation of Dissolution Rate from Cefpodoxime Proxetil Loaded Self Solidifying Solid SNEDDS.

Background: Cefpodoxime Proxetil (CPD) is a broad-spectrum cephalosporin indicated in respiratory and urinary tract infections. CPD is a BCS class IV drug with pH-dependent solubility and has poor bioavailability. This study investigated the challenges of developing ternary components based on solid SNEDDS of CPD for in vitro dissolution rate enhancement and self-solidifying behaviour.