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Clinical Trials - Phase - IV

Written by Vanessa Jones, B.A  | Medically Reviewed by Dr. Sunil Shroff, MBBS, MS, FRCS (UK), D. Urol (Lond) on Aug 28, 2014
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Clinical Trials - Phase IV

Phase IV trials are post-marketing studies to delineate additional information including the drug's risks, benefits, and optimal use. It also involves post-launch safety surveillance and ongoing technical support of a drug, helping detect long term adverse effects in a larger population. In situations where adverse effects are detected the durgs usage may be restricted or at times even withdrawn.

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Phase IV studies can be conducted either by regulatory authorities or by the Pharmceutical company sponsoring the drug either for competitive or other reasons.

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Comments

jagan1206

can any one give me different names given to different phases in clinical studies?

infoalcpl

My colleagues and I have just concluded one of India's most in-depth studies on "Clinical Trials in India". We have looked at various areas such as:
- Market Trends
- Growth Drivers
- Regulatory Bodies and Framework
- Major Players.
-Etc.
We interviewed over 200 individuals and firms to collect the data in what we believe is one of the most detailed study on the subject in India.

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