What is a drug product defined as?

A drug product is defined as a finished dosage form that contains an active drug ingredient. This definition emphasizes that the drug product is the final formulation that is intended for patient use, which may include various forms such as tablets, capsules, injectables, or topical applications. The inclusion of an active ingredient is integral as it is the component that delivers the intended therapeutic effect.

The other options present concepts that, while relevant in the context of drug development and regulation, do not accurately define a drug product. Clinical study designs pertain to the methodologies used to test the efficacy and safety of drugs, while regulatory submissions refer to the formal documents submitted to regulatory authorities seeking approval for drugs. The mention of manufacturing facilities relates to the production process of drug products rather than what constitutes the drug product itself.