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Statistical Sections for Regulatory

Statistical Sections for Regulatory

Author: murphy wu

Statistical Sections for Regulatory

In order to ensure the healthy growth of the pharmaceutical market, while encouraging innovation and research, the US Food and Drug Administration (FDA) has developed a series of comprehensive measures and management tools. After the preclinical study is completed, when the drug sponsor has sufficient data to prove that the drug is safe, it is ready to submit an investigational new drug (IND) application to the FDA. If the FDA approves the IND application, a clinical trial (a study involving human subjects) can be implemented.

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