Generic Drugs

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Process validation

Establishing by objective evidence that a process consistently produces a result or product meeting its predetermined specifications.

Generic Drugs

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

Which of the following general ethical issues to conduct clinical trials?

	Widespread agreement that sound ethical standards must be observed in clinical research
	To participants subject irrespective of the geographic
	Economic setting in which Clinical Trial is undertaken
	Obtaining consent from a participant under access to better healthcare and payment
	A lack of appropriately trained people and resources in ethics committees

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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Opinion Poll

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