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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
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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Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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