Drug development refers to the process of bringing a new drug molecule into the market through preclinical and clinical practice. It requires substantial investments in terms of capital (∼$2.2 billion), human resources, research skills, and technological expertise. The process of drug development can be broadly classified into preclinical and clinical studies. The […]
Clinical trials are structured biomedical or behavioral research studies on healthy human volunteers as well as patients, intended to answer specific questions about experimental medicine or therapeutic interventions such as new vaccines, drugs, or dietary supplements. These trials are conducted only when the appropriate information is submitted to a government […]
“Nutraceuticals,” a term coined by Dr. Stephen DeFelice in 1989, refers to nutritionally enriched foods and dietary supplements that are purified and formulated health products containing bioactive food compounds. These products support optimal health by supplementing the diet with herbs, vitamins, minerals, and amino acids. They are intended to enhance […]
Clinical trials are medical research conducted on humans that is planned to assess the efficiency of a drug or treatment and add to medical information. Some trials involve healthy members of the public, and others involve patients who may be offered the option of taking part in a trial during their […]
Clinical Research and Clinical Trials Management: Contract research organization, sometimes also called as Clinical research organization (CRO) is an organization that serves pharmaceutical, biotechnology, medical companies and various consumer healthcare industries in the field of clinical research. CRO provides support in new drugs and/or medical devices development that includes pre-clinical […]
Regulatory Affairs is fundamental in shepherding the groundbreaking treatments through the approval process, ensuring that they meet rigorous standards for safety and efficacy. Each year, the United States Food and Drug Administration (FDA) receives a considerable number of New Drug Applications (NDAs) and Biologic License Applications (BLAs). However, from 2011 […]
Clinical trial plays a vital role in evaluating the safety and effectiveness of nutraceutical products. Nutraceuticals, the fusion of nutrition and pharmaceuticals, are gaining popularity as natural compounds that offer health benefits and disease prevention. They also provide a crucial avenue for validating these innovative therapies, exploring their potential benefits, […]
Clinical Trial in Nutraceuticals, which combine nutrition and pharmaceutical properties, have gained significant attention in promoting physical health, immunity, and longevity. A nutraceutical is any substance that is a food or part of a food that provides medical or health benefits, in addition to its basic nutritional value. These products […]
Medical Device Design and Development In the process of developing and introducing new medical devices to the market, verifying the essential design features is crucial. Design verification, which involves testing, inspection, and analysis, is a necessary step to ensure compliance with quality management standards such as ISO 13485. Additionally, validating […]
Post marketing surveillance (PMS) refers to monitoring of device/drug performance after successful completion of the clinical studies and the implementation of suitable action to improve patient safety. It is conducted after product is approved for sale by the European Union Medical Device Regulation (EUMDR) and the United States (US). It […]