Which of the following best defines an Investigational New Drug (IND)?

Which of the following best defines an Investigational New Drug (IND)?

• A. A new drug under patent consideration
• B. A drug that has been approved for public use
• C. A new drug or biological product used in clinical investigations
• D. A drug exclusively used for diagnostic procedures

Answer: (C)

An Investigational New Drug (IND) is best defined as a new drug or biological product that is used in clinical investigations. This definition is critical in the context of drug development, as it highlights the drug's status during the pre-approval phase, where it is still being tested for safety and efficacy in human subjects. Before a drug can be marketed, it must undergo rigorous testing, which is facilitated by obtaining an IND status from regulatory authorities like the FDA. In this context, the IND process allows for the safe evaluation of new therapies that have not yet received approval for general use, enabling researchers to gather important data on the drug's effects. This phase is crucial for determining whether a drug should advance toward regulatory approval and eventual public availability. Thus, the focus on clinical investigations underlines the significance of clinical trials in the drug development process, making option C the most accurate description of an IND. The other options do not capture the investigative aspect of an IND. For instance, a drug under patent consideration refers to its intellectual property status and does not encompass its clinical evaluation process. Similarly, a drug that has been approved for public use is no longer classified as an IND, as it has completed the necessary trials and received marketing authorization. Lastly,

An Investigational New Drug (IND) is best defined as a new drug or biological product that is used in clinical investigations. This definition is critical in the context of drug development, as it highlights the drug's status during the pre-approval phase, where it is still being tested for safety and efficacy in human subjects. Before a drug can be marketed, it must undergo rigorous testing, which is facilitated by obtaining an IND status from regulatory authorities like the FDA.

In this context, the IND process allows for the safe evaluation of new therapies that have not yet received approval for general use, enabling researchers to gather important data on the drug's effects. This phase is crucial for determining whether a drug should advance toward regulatory approval and eventual public availability. Thus, the focus on clinical investigations underlines the significance of clinical trials in the drug development process, making option C the most accurate description of an IND.

The other options do not capture the investigative aspect of an IND. For instance, a drug under patent consideration refers to its intellectual property status and does not encompass its clinical evaluation process. Similarly, a drug that has been approved for public use is no longer classified as an IND, as it has completed the necessary trials and received marketing authorization. Lastly,