Preclinical development
Preclinical Development
Preclinical development (pronunciation: pre-klin-i-kal de-vel-op-ment), also known as preclinical study or nonclinical study, refers to the stage of research that takes place before clinical trials can begin, and during which important feasibility, iterative testing and drug safety data are collected.
Etymology
The term "preclinical" is derived from the prefix "pre-", meaning "before", and "clinical", referring to patient-oriented medical care. The term "development" refers to the process of growth or advancement. Thus, "preclinical development" refers to the stages of research and testing that occur prior to the involvement of human subjects.
Related Terms
- Pharmacology: The branch of medicine that deals with the uses, effects, and modes of action of drugs.
- Toxicology: The study of the adverse effects of chemical substances on living organisms.
- Clinical Trials: Research investigations in which people volunteer to test new treatments, interventions or tests as a means to prevent, detect, treat or manage various diseases or medical conditions.
- Drug Discovery: The process by which new candidate medications are discovered.
- Regulatory Affairs: The function in pharmaceutical companies which ensures that their companies comply with all of the regulations and laws pertaining to their business.
Preclinical Development Process
The preclinical development process involves several key steps:
- Target Identification: This is the first step in the preclinical development process. It involves identifying a suitable target for a potential new drug.
- Lead Compound Identification and Optimization: Once a target has been identified, the next step is to identify a lead compound and optimize it for further development.
- Preclinical Testing: This involves testing the lead compound in vitro and in vivo to assess its safety and efficacy.
- Investigational New Drug (IND) Application: If the preclinical testing is successful, an IND application is submitted to the relevant regulatory authority.
See Also
External links
- Medical encyclopedia article on Preclinical development
- Wikipedia's article - Preclinical development
This WikiMD dictionary article is a stub. You can help make it a full article.
Languages: - East Asian
中文,
日本,
한국어,
South Asian
हिन्दी,
Urdu,
বাংলা,
తెలుగు,
தமிழ்,
ಕನ್ನಡ,
Southeast Asian
Indonesian,
Vietnamese,
Thai,
မြန်မာဘာသာ,
European
español,
Deutsch,
français,
русский,
português do Brasil,
Italian,
polski