Applied Clinical Research, Clinical Trials and Regulatory Affairs - Volume 4, Issue 2, 2017

Pharmaceutical drug discovery and development is an extensive, investment incurring, and unpredictable process that may take 8-12 years to make a drug reaching to market place. Originator companies generally ensure patent rights over the drug molecules discovered and developed by them at an early drug development stage. This is an effort to inhibit other competitor companies from synthesizing, use in manufacture, Read More

Background: Nutraceuticals are accessible in the form of dietary supplements, nutrients, herbal foods, genetically engineered foods, particular diet, and processed foods in the form of tablets, capsules, granules, and beverages. It provides all the essential requirements such as energy and nutrient supplements to the body, by supplementing a diet. Methods: The study basically involves all the three categories of research m Read More

Background: The field of nanotechnology is growing tremendously in vast areas with 13% nano-based products in cosmetic industry. The use of nanomaterials (NMs) in cosmetics formulations for different applications has led to safety concerns globally with aspects related to skin which comes in direct contact and indirectly to the environment with respect to waste management, and is the major issue that needs attentio Read More

Background: Herbal drugs obtained from medicinal plants are used by a majority of the people because of their safety and less side effects, but it is not completely true that herbal products do not have any side effects or toxic effects, they do carry risks. Regulatory authorities of different countries regulate the quality and standard of herbal drugs on the basis of problems associated with them such as herb-drug interaction Read More

Background: The dynamic pharmaceutical industry is driven by regulatory authorities viz. Central Drug Standard Control Organization (CDSCO) for India, European Agency for the Evaluation of Medicinal Products (EMEA) for Europe, Therapeutic Products Directorate (TPD) for Canada, Medicines and Healthcare Products Regulatory Agency (MHRA) for UK, Therapeutic Goods Administration (TGA) for Australia, Medicines Control Co Read More

Background: “Trial and Clinical” emanate from the Anglo-French trier and from the French cliniqu´e and from the Greek klinike respectively; which denotes to try and to the practice of taking care of the sick at the at the bedside. Discussion: Therefore, a clinical trial is the summation of activities or process of positioning something to a test. It's finally to validate whether said drugs is for the worth of treatment or for prevention an Read More

Background: Energy drinks have swooped the beverage industry of late, there are not much papers related to the regulatory status of energy drinks in India. This paper aims to look into their regulation in India in comparison to developed nations. Methods: The study was conducted by consulting bibliographic databases such as, academic journals, trade journals, books, market reports, newspaper articles, web pages of Read More

Background: Medical research is a very costly affair and of prime importance for the expansion of knowledge and discoveries of new medical treatments and cures. As a matter of fact a significant amount of medical research in hospitals is conducted on already stored patient data and often useful in devising better treatment modalities as well as in making policy suggestions. Keeping in view the tragedies in clinical trials Read More

Purpose: The aim of this paper is to look into current regulatory specifications and to collect comparative data of probiotics across the globe for understanding the ambiguities related to these regimes. Ultimately it will provide a platform, to develop harmonized guidelines for assurance of quality, premarketing safety assessment and for framing satisfactory regulatory requirements for future. Methods: The study was carrie Read More