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Preclinical Toxicology and Clinical Studies - Using Flow Cytometry throughout Development

Posted on: November 13, 2019

Preclinical Toxixology different speciesThe pursuit of better medicine may take many years because of the complicated and often indirect path of biomedical research. Do you find yourself confused or unclear about when to use flow cytometry in “bench-to-bedside” research? The key is to understand the differences between preclinical and clinical research.

Taking A Peek - Preclinical Research

Preclinical research focuses on how biological systems work and apply this information toward developing potential therapeutic drugs or biologics. These studies are typically done in vitro (e.g. tissue culture) or in animal models and are critical to understanding a molecule’s mechanism of action, identifying which cells respond to a given molecule, and defining potential biomarkers for future diagnostic tests. Flow cytometry is a powerful tool for preclinical research, and it can be used to help scientists profile therapeutics in various ways including cell proliferation analysis and intracellular cytokine staining.


Almost There - Preclinical Toxicology And Safety Screening

Preclinical studies are critical to identifying a promising drug or biologic as a candidate for clinical trials. But preclinical toxicology and safety testing is needed to assess a candidate’s toxicity and efficacy.  These assays can define the maximum tolerated dose and no-effect dose of a drug in different animal models and can assess the efficacy of a molecule using different experimental approaches like flow cytometry. Many preclinical toxicology and safety assays use flow cytometry analysis, such as cell phenotyping and cellular signaling analysis. 


Proof Of Principal - Clinical Studies

Clinical studies or trials occur in phases and are initiated after a therapeutic candidate has completed the preclinical development process. Phase I clinical trials assess the safety, tolerability, and efficacy of a drug or biologic. Phase II trials are used to establish a “proof-of-concept” such that a drug or biologic is having an effect in the treatment of a given condition or disease. Phase III/IV trials are larger in scope and provide key data for determining if a drug or biologic should be approved for clinical use by a regulatory agency like the FDA. Flow cytometry assays are vital to experimental analysis for many clinical trials by monitoring disease progression, identifying biomarkers that correlate to disease versus no disease, and characterizing critical immune responses.

The path of a drug or biologic from promising in vitro results to final approval is challenging and uncertain but using flow cytometry to aid in these phases of research and development could be essential to developing new treatments that are safe and effective.

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