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Clinical trials are performed to evaluate the safety and efficacy of new drugs and medical devices on human beings. Clinical trials are mandatory to introduce new drugs in the market place. All clinical trials go through four phases. Phase I trials test a drug’s safety on healthy volunteers.

 
 
 

Phase II and III trials test the drug’s efficacy on patients. Phase IV trials are conducted once the drug is marketed to monitor for its safety in larger populations. Most of the clinical trial business in the global market originates from the US and Europe and are directed to countries such as India, China and those in Eastern Europe.The global clinical research sector is exploring India by increasingly outsourcing clinical trials. Analysts are projecting that total clinical research spending in India will increase by more than 30% annually by 2010.

Importance of Clinical Research in New Drug Development Clinical research and development of a new drug comprises about twothirds of the total development costs. With increased focus on cost control across the global pharma companies, speedier, low-cost and reliable clinical trials are the major thrust of the manufacturers. Globally, clinical research is becoming a thrust research area as it is essential for the development of not only new drugs but also for new formulations and Drug Delivery Systems (DDS). With the advent of high throughput screening and bioinformatics tools, drug discovery processes have speeded up markedly making clinical evaluation and development as the rate-limiting controlling step towards final drug development. The global pharmaceutical market is estimated at US$427 bn and Research.

 
 
 
 

Marketing Mastermind Magazine, Clinical Research Industry in India, Global Market, Global Clinical Research Sector, Drug Delivery Systems, DDS, Global Pharma Companies, Research & Development, R&D, Good Clinical Practice, GCP, Good Laboratory Practice, GLP, Drugs Controller General of India, DCGI, Central Ethics Committee on Human Research , CECHR.