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Toxicology is a multidisciplinary study of the adverse effects of chemical substances on living organisms, and tangentially the diagnosis and treatment of exposures to those chemical substances. Toxicologists determine how plants, animals, and bacterial organisms are affected by agricultural chemicals, industrial chemicals, metals, vapors and gases, naturally occurring toxins, and drugs, typically caused by the absorption, distribution, metabolism, and excretion of those substances.<ref name="EatonGeneral10">{{cite book |url=https://books.google.com/books?id=jzCAKsa2CpMC&pg=PA1 |chapter=Chapter 1.01 General Overview of Toxicology |title=Comprehensive Toxicology |author=Eaton, D.L.; Gallagher, E.P. |editor=McQueen, C.A. |publisher=Elsevier |edition=2nd |pages=1–46 |year=2010 |isbn=9780080468686}}</ref> Like other fields, many subspecialties are associated with toxicology, including<ref name="EatonGeneral10" />:
Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)<ref name="MAGIDefinition04">{{cite web |url=https://www.magiworld.org/FdaGcpRecords?Pkey=1134 |title=Definition of Central Laboratory |work=FDA Good Clinical Practice (GCP) Q&A |publisher=Model Agreements & Guidelines International |date=19 April 2004 |accessdate=18 November 2021}}</ref><ref name="MinorHandbook06">{{cite web |url=https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover |title=Handbook of Assay Development in Drug Discovery |editor=Minor, L.K. |publisher=CRC Press |year=2006 |pages=488 |isbn=9781420015706}}</ref>:  


* analytical toxicology, for identifying toxicants;
* clinical studies
* biomedical toxicology, for identifying how toxicants cause disease;
* bioequivalence studies
* environmental toxicology, for evaluating the effects of environmental chemicals and contaminants;
* study design and management
* forensic toxicology, for evaluating how toxicants and other chemicals caused death;
* high-volume specimen testing
* molecular toxicology, for the application of molecular biology to toxicity;
* custom assay development
* occupational toxicology, for evaluating the effects of chemical exposure in the workplace; and
* test kit development and supply
* regulatory toxicology, for applying mechanistic information from toxicology to regulations and standards development.


Similar to a medical laboratory, a toxicology laboratory may focus on diagnostics or research. Test types may vary based on the focus. For example, toxicity testing on research animals may involve testing for acute toxicity, subacute toxicity, short-term subchronic toxicity, long-term chronic toxicity, reproductive toxicity, developmental toxicity, mutagenicity assays, irritation, allergic reaction, inhalation, and immunotoxicity.<ref name="EatonGeneral10" /> However, diagnostic testing will involve testing for drugs of abuse, poisons, and heavy metals, or other toxicants. Pharmacogenetic testing may also be performed to develop dosing regiments for a specific drug.<ref name="ARUPClin19">{{cite web |url=https://arupconsult.com/content/clinical-toxicology-testing |title=Clinical Toxicology Testing |work=ARUP Consult |publisher=ARUP Laboratories |date=June 2021 |accessdate=18 November 2021}}</ref><ref name="SofronescuPurpose18">{{cite web |url=https://www.aacc.org/cln/articles/2018/december/purpose-driven-toxicology-services-the-key-to-financial-success-and-client-confidence |title=Purpose-driven Toxicology Services: The Key to Financial Success and Client Confidence |author=Sofronescu, A.G. |work=Clinical Laboratory News |publisher=American Association for Clinical Chemistry |date=01 December 2018 |accessdate=18 November 2021}}</ref>
Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often referred to as "central laboratories," which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.<ref name="MAGIDefinition04" /><ref name="KarelinSelecting13">{{cite web |url=https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/ |title=Selecting a Central Laboratory |author=Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. |work=Contract Pharma |publisher=Rodman Media, Inc |date=06 May 2013 |accessdate=18 November 2021}}</ref> These central labs may also be contracted out to provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."<ref name="KarelinSelecting13" /> Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.<ref name="CovanceClinical">{{cite web |url=https://drugdevelopment.labcorp.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html |title=Global Network and Core Services |publisher=Labcorp Drug Development |accessdate=18 November 2021}}</ref><ref name="ACMCentral">{{cite web |url=https://www.acmgloballab.com/central-lab-services |title=Central Lab Services |publisher=ACM Global Laboratories |accessdate=18 November 2021}}</ref>
 
Toxicology laboratories in unique settings such as emergency departments of hospitals require extra consideration. For example, while toxicology testing in the emergency department is normal in regards to supporting and validating clinical findings, the testing must also take into account the legal ramifications of test results. Those results may be used in court cases, requiring strict chain-of-custody, full documentation, methodologies, and quality control results to be maintained. Additional specimens may be required by government bodies for their own testing, and as such the lab may want to add additional specimen collection to its official workflow. Additionally, personnel may need to become familiar with testimony procedures if required to testify in a criminal court case.<ref name="MagnaniClinical12">{{cite book |url=http://webapps.cap.org/apps/docs/store/PUB220_Toxicol_Sample.pdf |format=PDF |chapter=Chapter 2: Supporting the Emergency Department |title=Clinical Toxicology Testing: A Guide for Laboratory Professionals |author=Magnani, B.; Kwong, T.C. |editor=Magnani, B.; Bissell, M.G.; Kwong, T.C.; Wu, A.H.B. |publisher=College of American Pathologists |pages=7–14 |year=2012 |isbn=9780983706816}}</ref>


==References==
==References==
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{{Reflist|colwidth=30em}}

Revision as of 23:20, 21 January 2022

Medical research laboratories provide a regulated environment for the testing of the safety and efficacy of a variety of medical treatments and diagnostic devices, including medications, implants, and physician test kits. These facilities form the backbone of today's effective medical treatments, from cholesterol-lowering medications to pacemakers for the heart. In the U.S., these types of labs are overseen by the FDA. Medical research labs provide many different analytical and consulting services, including (but not limited to)[1][2]:

  • clinical studies
  • bioequivalence studies
  • study design and management
  • high-volume specimen testing
  • custom assay development
  • test kit development and supply

Medical research can happen in the private, government, and academic sectors. Private medical research labs are most often referred to as "central laboratories," which are contracted by pharmaceutical companies and medical device manufacturers. Though mentioned occasionally in its regulation and guidance, the U.S. Food and Drug Administration doesn't seem to provide a definition of the term "central laboratory." However, it gets used by some in the context of an analytical laboratory that provides analyses of biological specimens associated with clinical and bioequivalence studies (including multi-site studies, prompting the idea of a "central" lab handling sample analysis) performed at medical institutions.[1][3] These central labs may also be contracted out to provide "courier services for delivering lab kits and biosamples from/to medical institutions where diagnostics and treatment of patients is performed."[3] Analytical testing and other services at a central or contract lab include anatomic pathology, digital pathology, immunology, microbiology, flow cytometry, biomarker testing, pharmacokinetic testing, genomic testing, and specimen and biorepository management.[4][5]

References

  1. ↑ 1.0 1.1 "Definition of Central Laboratory". FDA Good Clinical Practice (GCP) Q&A. Model Agreements & Guidelines International. 19 April 2004. https://www.magiworld.org/FdaGcpRecords?Pkey=1134. Retrieved 18 November 2021. 
  2. ↑ Minor, L.K., ed. (2006). "Handbook of Assay Development in Drug Discovery". CRC Press. pp. 488. ISBN 9781420015706. https://books.google.com/books?id=RmrLBQAAQBAJ&printsec=frontcover. 
  3. ↑ 3.0 3.1 Karelin, A.; Belotserkovskiy, M.; Khokhlova, V.; Kumar, A. (6 May 2013). "Selecting a Central Laboratory". Contract Pharma. Rodman Media, Inc. https://www.contractpharma.com/issues/2013-05/view_features/selecting-a-central-laboratory/. Retrieved 18 November 2021. 
  4. ↑ "Global Network and Core Services". Labcorp Drug Development. https://drugdevelopment.labcorp.com/services/clinical-testing/central-laboratory-services/core-laboratory-testing-services.html. Retrieved 18 November 2021. 
  5. ↑ "Central Lab Services". ACM Global Laboratories. https://www.acmgloballab.com/central-lab-services. Retrieved 18 November 2021. 
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