How are investigational products defined in ICH GCP?

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Multiple Choice

How are investigational products defined in ICH GCP?

In ICH GCP, the term investigational product refers to any medicinal product that is being tested in a clinical trial or used as a reference in the trial. This includes the active substance or placebo, and can cover new active substances that are not yet approved. Because the focus is on medicinal products used in trials, the scope includes drugs, medicines, medicinal products, vaccines, and biological products. Devices or cosmetics fall outside this medicinal-product definition and are governed by different regulatory concepts. So the best answer captures that an investigational product is synonymous with the various forms of medicinal products used in a trial.

In ICH GCP, the term investigational product refers to any medicinal product that is being tested in a clinical trial or used as a reference in the trial. This includes the active substance or placebo, and can cover new active substances that are not yet approved. Because the focus is on medicinal products used in trials, the scope includes drugs, medicines, medicinal products, vaccines, and biological products. Devices or cosmetics fall outside this medicinal-product definition and are governed by different regulatory concepts. So the best answer captures that an investigational product is synonymous with the various forms of medicinal products used in a trial.

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