Preclinical Study
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A Preclinical Study is a Randomized-Controlled Experimental Study that involves other living systems than humans as test subjects in the testing of a new medical intervention/treatment and medical product.
- AKA: Non-Human Clinical Trial, Preclinical Testing, Laboratory Clinical Study.
- Context:
- It (often) precedes Human Clinical Trials.
- It can range from being an In-Vitro Preclinical Trial to being an In-Vivo Preclinical Trial.
- Example(s):
- Counter-Example(s):
- See: Clinical Trial Phase, Clinical Trial Measure, Approved Drug, Drug Development Clinical Trial, Toxicity, Medical Device, Prescription Drug, Diagnosis, Drug Discovery, Good Clinical Practice.
References
2022a
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Preclinical_development Retrieved:2022-1-15.
- QUOTE: In drug development, preclinical development, also termed preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (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 first-in-human study and assess potential toxicity of the product, which typically include new medical devices, prescription drugs, and 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.
- QUOTE: In drug development, preclinical development, also termed preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
2022b
- (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Preclinical_studies Retrieved:2022-1-15.
- QUOTE: Before clinical trials are undertaken for a candidate drug, vaccine, medical device, or diagnostic assay, the product candidate is tested extensively in preclinical studies. Such studies involve in vitro (test tube or cell culture) and in vivo (animal model) experiments using wide-ranging doses of the study agent to obtain preliminary efficacy, toxicity and pharmacokinetic information. Such tests assist the developer to decide whether a drug candidate has scientific merit for further development as an investigational new drug.
2016
- (Grant, 2016) ⇒ William B. Grant (2016). "The role of geographical ecological studies in identifying diseases linked to UVB exposure and/or vitamin D". In: Dermato Endocrinology 8(1):e1137400. DOI:10.1080/19381980.2015.1137400.
- QUOTE: Four methods exist to determine whether UVB exposure and vitamin D affect disease outcomes: ecological studies, observational studies, laboratory studies, and clinical trials.
- Ecological studies can be of 2 types:
- Geographical. Health outcomes and risk-modifying factors are averaged for populations divided along geographical lines.
- Temporal. Health outcomes are examined for seasonal variations or trends.
- Observational studies come in several forms:
- Case–control. Risk-modifying factors measured at the time of disease diagnosis.
- Cohort and nested case–control. Subjects are enrolled in a study, risk-modifying factors are assessed, and then the cohort is monitored (for up to many years). Those who develop diseases are compared with like individuals who did not.
- Cross-sectional. An entire population is sampled, with health status and health parameters and risk-modifying factors measured.
- Laboratory studies are generally of 3 types:
- Animal studies. Animal models of various diseases are challenged with various agents.
- Detailed cell and tissue analysis. Cells and tissues from patients can be examined for genetic variations, etc.
- In clinical trials, people are enrolled and randomly assigned to take a substance or a placebo for a specified time. The object is to see whether taking the agent yields a better result for the outcome of interest.