IND
IND or Investigational New Drug is a term used in the pharmaceutical industry to describe a new drug that is in the process of being tested but has not yet been approved by the FDA for general use. The IND application is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines before a marketing application for the drug has been approved.
Overview[edit | edit source]
The IND application must contain data from preclinical testing and animal studies that show it is safe to test the drug on humans. The application also includes a detailed plan for the proposed clinical trial, which is designed to answer specific questions about the drug's safety and effectiveness.
Preclinical Testing[edit | edit source]
Before an IND application is submitted, the drug must undergo extensive preclinical testing. This involves laboratory testing and animal studies to evaluate the drug's safety and effectiveness. The results of these tests are included in the IND application.
Clinical Trials[edit | edit source]
Once the IND application is approved, the drug can proceed to clinical trials. These are conducted in three phases:
- Phase I trials test the drug on a small group of healthy volunteers to evaluate its safety, determine a safe dosage range, and identify side effects.
- Phase II trials involve a larger group of people who have the condition the drug is intended to treat. This phase is designed to evaluate how well the drug works and to further evaluate its safety.
- Phase III trials are conducted on large groups of people to confirm the drug's effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug to be used safely.
Post-Marketing Surveillance[edit | edit source]
After a drug has been approved by the FDA and is on the market, it is subject to post-marketing surveillance. This is a phase IV clinical trial that monitors the drug's performance in the general population and detects any rare or long-term side effects.
See Also[edit | edit source]
- Clinical trial
- Food and Drug Administration
- Pharmaceutical industry
- Preclinical testing
- Post-marketing surveillance
| IND Resources | |
|---|---|
|
 |
Search WikiMD
Ad.Tired of being Overweight? Try W8MD's physician weight loss program.
Semaglutide (Ozempic / Wegovy and Tirzepatide (Mounjaro / Zepbound) available.
Advertise on WikiMD
|
WikiMD's Wellness Encyclopedia |
| Let Food Be Thy Medicine Medicine Thy Food - Hippocrates |
Translate this page: - East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
தமிழ்,
తెలుగు,
Urdu,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
বাংলা
European
español,
Deutsch,
français,
Greek,
português do Brasil,
polski,
română,
русский,
Nederlands,
norsk,
svenska,
suomi,
Italian
Middle Eastern & African
عربى,
Turkish,
Persian,
Hebrew,
Afrikaans,
isiZulu,
Kiswahili,
Other
Bulgarian,
Hungarian,
Czech,
Swedish,
മലയാളം,
मराठी,
ਪੰਜਾਬੀ,
ગુજરાતી,
Portuguese,
Ukrainian
Medical Disclaimer: WikiMD is not a substitute for professional medical advice. The information on WikiMD is provided as an information resource only, may be incorrect, outdated or misleading, and is not to be used or relied on for any diagnostic or treatment purposes. Please consult your health care provider before making any healthcare decisions or for guidance about a specific medical condition. WikiMD expressly disclaims responsibility, and shall have no liability, for any damages, loss, injury, or liability whatsoever suffered as a result of your reliance on the information contained in this site. By visiting this site you agree to the foregoing terms and conditions, which may from time to time be changed or supplemented by WikiMD. If you do not agree to the foregoing terms and conditions, you should not enter or use this site. See full disclaimer.
Credits:Most images are courtesy of Wikimedia commons, and templates Wikipedia, licensed under CC BY SA or similar.
Contributors: Prab R. Tumpati, MD
