Experimental Drug
An Experimental Drug is a therapeutic substance (a drug or vaccine) that is within a clinical development task.
- AKA: Investigational Drug, Clinical Test Drug.
- Context:
- It can be an Approved Experimental Drug (has been approved by a drug approving authority).
- …
- Example(s):
- an illicit drug (e.g. Lysergic Acid Diethylamide) that has been approved to be used in an experimental treatment.
- …
- Counter-Example(s):
- See: Experimental Treatment, Drug, Drug Discovery, Drug Design, Drug Development, Drug Addiction, Recreational Drug Use, Responsible Drug Use.
References
2022
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#I Retrieved:2022-3-20.
- Investigational drug
- A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people. A drug may be approved by the FDA for use in one disease or condition but be considered investigational in other diseases or conditions. Also called experimental drug. (NCI)
- A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use. (ICH E6)
- Investigational New Drug
- A new drug, antibiotic drug, or biological drug that is used in a clinical investigation. It also includes a biological product used in vitro for diagnostic purposes. (NLM)
- Investigational drug
2021a
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Experimental_drug Retrieved:2021-12-31.
- An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions.
In the United States, the body responsible for approval is the U.S. Food and Drug Administration (FDA), which must grant the substance Investigational New Drug (IND) status before it can be tested in human clinical trials. IND status requires the drug's sponsor to submit an IND application that includes data from laboratory and animal testing for safety and efficacy. A drug that is made from a living organism or its products undergoes the same approval process but is called a biologics license application (BLA). Biological drugs include antibodies, interleukins, and vaccines. In Canada, a Clinical Trial Application (CTA) must be filed with the Health Products and Food Branch (HPFB) of Health Canada before starting a clinical trial. If the clinical trial results show that therapeutic effect of the drug outweighs negative side effects then the sponsor can then to file a New Drug Submission. Clinical trials in the European Union (EU) are regulated by the European Medicines Agency (EMA). Beginning in 2019 all applications for clinical trials must use a centralize EU portal and database. All clinical trial results will available to the public with the summary written in layperson's language.
- An experimental drug is a medicinal product (a drug or vaccine) that has not yet received approval from governmental regulatory authorities for routine use in human or veterinary medicine. A medicinal product may be approved for use in one disease or condition but still be considered experimental for other diseases or conditions.
2021b
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research#E Retrieved:2021-12-31.
- Experimental drug
- A drug that is not FDA licensed for use in humans, or as a treatment for a particular condition (NLM)
- A substance that has been tested in a laboratory and has gotten approval from the U.S. Food and Drug Administration (FDA) to be tested in people. A drug may be approved by the FDA for use in one disease or condition but be considered experimental or investigational in other diseases or conditions. Also called investigational drug. (NCI)
- Experimental drug
2021c
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Approved_drug Retrieved:2021-11-14.
- An approved drug is a preparation that has been validated for a therapeutic use by a ruling authority of a government. This process is specific by country.
2021d
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Glossary_of_clinical_research Retrieved:2021-11-14.
- Approved drugs
- In the U.S., the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application y.
- Approved drugs