In-Vitro Preclinical Trial

An In-Vitro Preclinical Trial is a Preclinical Trial that is involves in-vitro testing to predict clinical endpoints.

• AKA: Test Tube Preclinical Trial, Cell Culture Preclinical Trial.
• Example(s):
  • Tissue Culture Preclinical Trial,
  • Wheat Germ Preclinical Trial,
  • …
• Counter-Example(s):
  • In-Vivo Preclinical Trial,
  • Animal Preclinical Trial,
  • Plant Preclinical Trial,
  • First-In-Human Clinical Trial.
• See: Drug Development Clinical Trial, Clinical Trial, Clinical Research, Animal Disease Model, Polymerase Chain Reaction, Protein Purification, In-Vitro Fertilization, In-Vitro Diagnostics.

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References

2022a

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/Phases_of_clinical_research#Preclinical_studies Retrieved:2022-1-15.
  • 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.

2022b

• (Wikipedia, 2022) ⇒ https://en.wikipedia.org/wiki/In_vitro Retrieved:2022-1-15.
  • In vitro (meaning in glass, or in the glass) studies are performed with microorganisms, cells, or biological molecules outside their normal biological context. Colloquially called “test-tube experiments", these studies in biology and its subdisciplines are traditionally done in labware such as test tubes, flasks, Petri dishes, and microtiter plates. Studies conducted using components of an organism that have been isolated from their usual biological surroundings permit a more detailed or more convenient analysis than can be done with whole organisms; however, results obtained from in vitro experiments may not fully or accurately predict the effects on a whole organism. In contrast to in vitro experiments, in vivo studies are those conducted in living organisms, including humans, and whole plants.

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.

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