1 · Introduction Pharmacovigilance (PV) is the “science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem” (WHO). In an era of precision medicine, globalised supply chains and accelerated approvals, PV has become indispensable for safeguarding patients throughout the therapeutic life-cycle—from first-in-human dosing to decades of post-marketing … Read more
Introduction: The Gatekeepers of Drug Development Preclinical trials are the cornerstone of medical research and development. They serve as the critical “gatekeeper” stage in the long journey of bringing a new drug to market. While often simplified as “animal testing,” preclinical development is a highly regulated, scientifically rigorous process designed to bridge the gap between … Read more
Clinical trials are research studies that evaluate the safety and efficacy of medical interventions, such as drugs, devices, or treatments, in humans. These trials are essential for gaining regulatory approval for new therapies and are conducted in multiple phases. Below is a detailed description of each phase and examples of drugs that have undergone or … Read more
Drug discovery and development is an intricate and multifaceted process that encompasses identifying, designing, and testing prospective new drugs. The primary objective is to discover secure and effective treatments for various ailments and conditions. This composition will delve into the various stages of drug design and screening and the several phases of clinical trials. Drug … Read more