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Standard of care

Treatment that is accepted by medical experts as a proper treatment for a certain type of disease and that is widely used by healthcare professionals. Also called best practice, standard medical care, and standard therapy.

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.
 
 

Opinion Poll

As per CDSCO-guidance for industry, which form is required Common Submission for Import Licence of Medical Devices in India?
 
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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