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Asked by : Sanjay Saha, Product/Brand Manager, Dr Reddy Labs
Industry : Pharmaceuticals
Functional Area : R&D
Activity: Question posted: 10 09 2009 08:31:10 +0000, 3 answers, 686 views, last activity 07 06 2010 20:18:08 +0000
 
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Clinical trials are expected to have huge growth in India. How the clinical trials are conducted and how many phases does it have?

 
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Can we call clinical trial phases as first phase of guniea Humans ,coming after lab mice and guniea pigs?

 



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by   Charles davison, Project Manager, Douglas OHI LLC  | 10 09 2009 09:17:02 +0000
  Answered by     Bindu Narayan, Product Development Manager, Care Biomedicals  | 10 09 2009 11:55:10 +0000
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In the first phase, the product is tested on a few people to check its effectiveness, safety , tolerability, pharmacokinetics, and pharmacodynamics of a drug. In the second phase, it is tested on comparatively a bit more number of people and is evaluated on the same standards. In the third phase, they evaluate its effectiveness, monitor side effects and collect information that will allow the drug to be used safely. Then finally the drug is marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

  Answered by     Kaushik Dutta, Product Development Manager, Biocon  | 10 09 2009 08:47:22 +0000
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Normally there are four major phases through which the clinical trials are conducted. In the first phase of the trails  researchers test a new drug in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. Then in the second phase the drug is given to a larger group of people to see if it is effective and to further evaluate its safety. In third phase they confirm its effectiveness, monitor side effects and collect information that will allow the drug to be used safely. Then finally the drug is marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

 
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