Types of IND programs:

• Commercial:

Commercial IND applications are filled by the drug companies or sponsors to obtain marketing approval for a new drug. The main purpose of the research is to collect the data required by FDA to bring the product to the market.

• Research:

The main purpose of the research IND application is to prove efficacy for a new indication of an already approved drug. The researchers are usually intended to test a new dosage or improvements of a drug.

• Emergency Use:

Emergency use INDs are also called compassionate use or single-patient INDs. This kind of application is usually filled for emergency use of an unapproved drug in a life-threatening situation in which no standard treatment is available and in which there is no sufficient time to obtain the IRB approval (Institutional Review Board approval. IRB is a group that has been formally designated to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and well-being of human new dr subjects.)

• Treatment:

Treatment IND applications are usually filled to get the approval to use a drug for the treatment of serious or immediately life-threatening conditions if approved by the FDA. Serious diseases or conditions are schizophrenia, stroke, chronic depression, seizures, etc.

• Screening:

This type of application is filled to investigate multiple, closely related compounds in order to screen for the preferred compounds or formulations. The preferred compound can then be developed further under a separate IND. This type of IND is usually used for screening drugs that are chemically different, but pharmacologically similar.

Categories of INvestigational new drug

Manufacturing Information 

For the investigational new drug studies, it is essential to study the manufacturing information of the drug, for example, the temperature conditions, controls, structure, and method. For this study, it is very important to know the manufacturing information. For instance, in the first step, the process is done, and in the second step of manufacturing the drug, the active drug is converted into a product that can be intake. 

Animal Pharmacology and Toxicology Studies 

It is the second category of the investigational new drug. In this category, scientists Study the toxicity of drugs on animals and observe the molecular and cellular nature of the drug in animal pharmacology. These are essential steps for investigational new drug studies. 

Clinical Protocols and Investigator Information 

For FDA approval, it is important to submit the clinical protocols and the investigation of every trial. Without the clinical protocols, the trial is considered incomplete and can be rejected by the Food and Drug Administration.