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Q of the week

Q: How Do You Get Shingles?

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Crohn's disease

Crohn's disease is an ongoing condition that causes inflammation of the digestive tract, or the GI (gastrointestinal) tract (the gut).
Generic Drugs
  1. What are the guidelines and ethical considerations to follow when there is a trial involving comparison between generic brands? What phase it exactly fits in?
    The procedure is similar to any other clinical trial. ICH-GCP guidelines need to be followed. The design would depend on the indication and the endpoints. To consider the phase of the clinical trial we need to consult ICH-GCP E8 General Considerations for Clinical Trials which provides detailed discussion on the classification.
  		 


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