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What information is included in an Investigational New Drug application?

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An Investigational New Drug (IND) application is a required document submitted to the U.S. FDA by pharmaceutical firms seeking approval to begin human clinical trials for a new drug.1

To ensure the safety and ethical treatment of human subjects, an IND application must include the following information:

Chemical and Dosage Details: Information regarding the chemical makeup of the drug and its specific dosage form.1
Preclinical Data: Summaries of animal pharmacology and toxicology studies.1
Pharmacokinetic Data: Information regarding how the drug moves through the body.1
Previous Investigations: Details concerning any prior clinical investigations of the drug.1
Study Protocols: Descriptions of the trials to be conducted, including Phase 1 protocols, which outline the initial use of the drug in humans to assess safety and dosage profiles.1

This application is a critical step in the development process, ensuring that research is conducted with scientific rigor before a drug is considered for broader marketing approval.1