Under International Council for Harmonisation (ICH) guidelines, clinical efficacy evaluation for a new drug must primarily include which of the following?

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Pharmacy · Regulatory Affairs

Verified Solution4 OptionsUpdated: October 2026👁️1 View

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Adequate and well-controlled evidence from human clinical trials

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Answer 1

Data derived exclusively from preclinical animal studies

Answer 2

Adequate and well-controlled evidence from human clinical trials

Answer 3

Results obtained from stability testing alone

Answer 4

Commercial product labeling information only

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