2020
DOI: 10.1177/2472555220923332
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Recommended Guidelines for Developing, Qualifying, and Implementing Complex In Vitro Models (CIVMs) for Drug Discovery

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Cited by 43 publications
(50 citation statements)
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References 89 publications
(115 reference statements)
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“…7 In addition, MPS are also responsive to the 3R principles of animal use in research -refinement, reduction, and replacement -and offer a way for significant reduction on the use of animals or animal models for preclinical studies. 8,24 It is now becoming increasingly clear that MPS can serve as in vitro tools within many areas of drug development, 25,26 including serving as physiologically-relevant platforms for early lead compound target validation and therapeutic safety and toxicity assessment during the preclinical phase. 12,[27][28][29] In addition, MPS can be used for modeling of both common and rare diseases, 7 with successful modeling of a number of rare disorders, such as Progeria, 30,31 Barth syndrome, 32 and hereditary hemorrhagic telangiectasia.…”
Section: Impact Statementmentioning
confidence: 99%
See 1 more Smart Citation
“…7 In addition, MPS are also responsive to the 3R principles of animal use in research -refinement, reduction, and replacement -and offer a way for significant reduction on the use of animals or animal models for preclinical studies. 8,24 It is now becoming increasingly clear that MPS can serve as in vitro tools within many areas of drug development, 25,26 including serving as physiologically-relevant platforms for early lead compound target validation and therapeutic safety and toxicity assessment during the preclinical phase. 12,[27][28][29] In addition, MPS can be used for modeling of both common and rare diseases, 7 with successful modeling of a number of rare disorders, such as Progeria, 30,31 Barth syndrome, 32 and hereditary hemorrhagic telangiectasia.…”
Section: Impact Statementmentioning
confidence: 99%
“…88,91 In addition to the need for further MPS characterization, the IQ MPS Affiliate have identified a variety of other hurdles impeding MPS adoption in the pharmaceutical industry including the need for standards, bridging and comparing pre-clinical animal model data with tissue chip data, providing enough data to increase confidence in the technology, and increasing throughput for specific applications. 25,91 For example, the level of throughput needed varies widely based on CoU, e.g. the quantity of actively investigated compounds and the degree of certainty required to inform data-driven decisions.…”
Section: Impact Statementmentioning
confidence: 99%
“…A standard approach for the validation of a novel safety model, is to determine the sensitivity and specificity of the model with a set of compounds that have a large body of preclinical and clinical data available [ 41 , 42 ]. Once the dynamic range of the model is established, clinical safety outcomes are then replicated in an acute or chronic state.…”
Section: Evaluating Drug Safety and Efficacymentioning
confidence: 99%
“…This recognition has led to the development of increasingly sophisticated 3D cell cultures to more accurately reproduce the complexity of an in vivo environment. Using scaffolds, hydrogels, and microfabricated devices, 3D cell culture technology has rapidly developed as a promising assay for testing of drug delivery, metabolism, pharmacology, and toxicity 16 . MALDI IMS has the potential to be a key part of the analytical strategy for assessing 3D cell cultures by measuring drug penetration, distribution, and cellular response to the drug and other stimuli.…”
Section: Study Conductmentioning
confidence: 99%
“…Using scaffolds, hydrogels, and microfabricated devices, 3D cell culture technology has rapidly developed as a promising assay for testing of drug delivery, metabolism, pharmacology, and toxicity. 16 MALDI IMS has the potential to be a key part of the analytical strategy for assessing 3D cell cultures by measuring drug penetration, distribution, and cellular response to the drug and other stimuli. The ability to assess multiple treatment conditions across several time points on a well‐controlled, yet biologically relevant, sample is highly attractive.…”
Section: Study Conductmentioning
confidence: 99%