An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. What is the investigator's most appropriate course of action?

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08-10-2019
Health

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An investigator proposes to study a marketed product sold to treat high blood pressure in individuals over age 12 using a liquid formulation for children under age 12. The drug sponsor hopes that the information from the research can be used to change the labeling for use of the drug in younger children. What is the investigator's most appropriate course of action?

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BarrettArcher BarrettArcher · Answer 1 · 2019-10-09T16:44:27+02:00

Answer:

Hypertension or high blood pressure indicates above then the normal value of the blood pressure. Different medicines are available in the market to treat the high blood pressure.

As the investigator wants to change the labeling of the drug. He must have submit the research protocol to International review board. His protocol must be submitted and reviewed. The application them submitted to FDA before starting the research.