News By Tag Industry News News By Location Country(s) Industry News
| Post Marketing Clinical ResearchPost Marketing Clinical Research will Lead to Better Drug Safety and an Increase in Revenues
By: Rajesh Gunnam For Sample Pages, please click or add the below link to your browser: http://www.gbiresearch.com/ The GBI Research’s report on, “Post Marketing Clinical Research - REMS, the Latest Reformation due to Post Marketing Surveillance to Enhance Patient Compliance”, provides in-depth analysis of components of post marketing clinical research and its applications. This report provides regulatory landscape of post marketing clinical research in different geographies. The report provides detailed description about conduct of post marketing clinical research in special groups including different populations groups, different therapy areas and drug classes. In this report detailed analysis about outsourcing of post marketing clinical research have been provided. This report showcases criteria for selection of outsourcing partner along with advantages and limitations of outsourcing. Post marketing clinical research is defined as the study of marketed medicinal products. The key objective of this research is the evaluation of drug safety. These studies have been conducted to confirm unrecognized safety issues, investigate hazards and to identify risk factors associated with the use of medicinal products. The pharmaceutical industry is facing a number of challenges in bringing safe and effective products to the market. The key challenge is the increase in the needs of physicians and patients, namely improved therapeutic benefits and cost effectiveness. Pre-marketing trials are ineffective in solving these issues as their objectives differ. Post marketing clinical research is effective in answering the unmet needs of physicians and patients. Clinical trials are designed to measure the safety and efficacy of new drugs in patient populations. Preclinical research and clinical phases I to III are designed to obtain market approval from regulatory agencies. Phase I studies are mainly conducted to generate information about the toxicity of a New Molecular Entity (NME). Phase II studies are aimed at determining effectiveness and dosage regimens. Phase III studies are aimed at confirming effectiveness in large populations. Drug development phases are aimed at generating information important for obtaining market approval, have a restricted design and end with limited research. Post marketing research is advantageous as it eliminates the participation of a controlled population as is the case with premarketing trials. Special population groups who were not included in earlier phases of clinical trials due to factors such as inclusion criteria are included in the post marketing research. In post marketing research a drug is studied in population groups containing different types of patients, which is helpful in studying safety in different groups. For further details, please click or add the below link to your browser: http://www.gbiresearch.com/ Visit our report store: http://www.gbiresearch.com For more details contact: pressreleases@ North America: +1 646 395 5477 Europe: Asia Pacific: # # # GBI Research is a market-leading provider of business intelligence reports. GBI Research covers worldwide markets and issues, supplies actionable data and forecasts and is driven by industry leaders’ insights. GBI Research provides a broad spectrum of reports across the healthcare and energy industries and its online offering is easy to navigate - a comprehensive resource for business information needs. End
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||
Account Phone Number