During clinical trials, what is a proposed new drug referred to as?

During clinical trials, what is a proposed new drug referred to as?

• A. IND
• B. HMO
• C. AZT
• D. CDRH

Answer: (A)

In the context of clinical trials, a proposed new drug is referred to as an Investigational New Drug, commonly abbreviated as IND. This term is used in the early phases of drug development, where the drug is being tested for safety and efficacy in humans before it can be marketed. During this stage, the manufacturer must submit an IND application to the Food and Drug Administration (FDA), which includes data from laboratory and animal studies, details about the drug's composition, and protocols for clinical trials. This ensures that the drug is being tested ethically and safely. The other options represent different concepts: HMO refers to Health Maintenance Organization, which relates to health insurance; AZT is a specific drug used to treat HIV; and CDRH stands for the Center for Devices and Radiological Health, which oversees medical devices rather than drugs. Thus, the term IND specifically pertains to the classification of a new drug under investigation during clinical trials.

In the context of clinical trials, a proposed new drug is referred to as an Investigational New Drug, commonly abbreviated as IND. This term is used in the early phases of drug development, where the drug is being tested for safety and efficacy in humans before it can be marketed.

During this stage, the manufacturer must submit an IND application to the Food and Drug Administration (FDA), which includes data from laboratory and animal studies, details about the drug's composition, and protocols for clinical trials. This ensures that the drug is being tested ethically and safely.

The other options represent different concepts: HMO refers to Health Maintenance Organization, which relates to health insurance; AZT is a specific drug used to treat HIV; and CDRH stands for the Center for Devices and Radiological Health, which oversees medical devices rather than drugs. Thus, the term IND specifically pertains to the classification of a new drug under investigation during clinical trials.