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Drug Standards
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Drug Standards
 
Drug Trial Standards Drug Trial Standards
What is International Conference on Harmonization What is International Conference on Harmonization ?
What is Good Clinical Practice? What is Good Clinical Practice?
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Drug Standards
 
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Drug Trial Standards Drug Trial Standards
  Drug Trials often involve many countries around the world. Therefore, having standards that are accepted worldwide is important to in conduct these trials. International Conference on Harmonization (ICH) is an organization created to facilitate the establishment of global standards - Good Clinical Practice.
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What is International Conference on Harmonization ? What is International Conference on Harmonization ?
 

It is a group that includes the regulatory authorities of Europe, Japan, and the United States. They discuss scientific/technical aspects of pharmaceutical registration for human use. The purpose is to recommend how to achieve greater harmonization in the interpretation and application of requirements for product registration (to reduce the need of duplicating tests during the research and development of new medicines).

(http://www.ifpma.org/ich1.html)

   
 
What is International Conference on Harmonization ?
 
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What is Good Clinical Practice? What is Good Clinical Practice?
 

It is the "Gold Standard" for conducting clinical trials. It ensures high ethical standards, protection of the rights, safety, and well-being of trial subject; high scientific quality standards and accurate trial data. This guideline is based on the Declaration of Helsinki (originally issued in 1964), which states that the principles of biomedical research is to safeguard the health of patients. It was finalized in May 1996, and adopted by the key parties (USA, European Union, and Japan) in 1997. Other related parties, such as Australia, Canada, and the World Health Organization (WHO) have also later adopted this guideline.

(http://www.ifpma.org/ich5e.html#GCP)

 
What is Good Clinical Practice?
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