Editing Preclinical development (section)

{{Short description|Stage of drug development}}
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In [[drug development]],  '''preclinical development''' (also termed '''preclinical studies''' or '''nonclinical studies''') is a stage of research that begins before [[clinical trial]]s (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.

The main goals of preclinical studies are to determine a starting, safe dose for [[Phases of clinical research#Phase I|first-in-human study]] and assess potential [[toxicity]] of the product, which typically include new [[medical device]]s, [[prescription drug]]s, and [[Diagnosis|diagnostics]].

Companies use stylized statistics to illustrate the risks in preclinical research, such as that on average, only one in every 5,000 compounds that enters [[drug discovery]] to the stage of preclinical development becomes an [[approved drug]].<ref>{{cite news | first = Ezekiel J. | last = Emanuel |author-link = Ezekiel J. Emanuel |title=The Solution to Drug Prices |url=https://www.nytimes.com/2015/09/09/opinion/the-solution-to-drug-prices.html?_r=0 |quote=On average, only one in every 5,000 compounds that drug companies discover and put through preclinical testing becomes an approved drug. Of the drugs started in clinical trials on humans, only 10 percent secure F.D.A. approval. ... |newspaper=[[New York Times]] | date = 9 September 2015 }}</ref><ref>{{Cite web|title=Drug Approvals - From Invention to Market...12 Years!|url=https://www.medicinenet.com/script/main/art.asp?articlekey=9877|access-date=2021-04-21|website=MedicineNet|language=en}}</ref>