Non-Invasive Imaging in the Pharmaceutical Industry

Ricketts, Sally‐Ann; Hockings, Paul; Waterton, John C.

doi:10.1007/978-3-642-12945-2_2

Cited by 7 publications

(4 citation statements)

References 15 publications

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“…In this context, the other Rs of the Directive 2010/63/EU could still be considered, namely the Reduction and Refinement of the use of animals for scientific purposes. In vitro and in silico TK data as well as imaging can allow to (i) reduce the number of animals used to obtain the same information or with the same number of animals expand the information collected, (ii) refine animal experimentation by moving from severe to mild suffering by favouring non-invasive approaches as an example ( Ricketts et al, 2011 ; Kramer and Font, 2015 ). Besides, the most commonly used in vitro models are often reproached to lose their tissue-specific physiology including their transportome profile.…”

Section: Discussionmentioning

confidence: 99%

Capturing the applicability of in vitro-in silico membrane transporter data in chemical risk assessment and biomedical research

Clerbaux

Coecke

Lumen

et al. 2018

Science of The Total Environment

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Costs, scientific and ethical concerns related to animal tests for regulatory decision-making have stimulated the development of alternative methods. When applying alternative approaches, kinetics have been identified as a key element to consider. Membrane transporters affect the kinetic processes of absorption, distribution, metabolism and excretion (ADME) of various compounds, such as drugs or environmental chemicals. Therefore, pharmaceutical scientists have intensively studied transporters impacting drug efficacy and safety. Besides pharmacokinetics, transporters are considered as major determinant of toxicokinetics, potentially representing an essential piece of information in chemical risk assessment. To capture the applicability of transporter data for kinetic-based risk assessment in non-pharmaceutical sectors, the EU Reference Laboratory for Alternatives to Animal Testing (EURL ECVAM) created a survey with a view of identifying the improvements needed when using in vitro and in silico methods.Seventy-three participants, from different sectors and with various kinds of expertise, completed the survey. The results revealed that transporters are investigated mainly during drug development, but also for risk assessment purposes of food and feed contaminants, industrial chemicals, cosmetics, nanomaterials and in the context of environmental toxicology, by applying both in vitro and in silico tools. However, to rely only on alternative methods for chemical risk assessment, it is critical that the data generated by in vitro and in silico methods are scientific integer, reproducible and of high quality so that they are trusted by decision makers and used by industry. In line, the respondents identified various challenges related to the interpretation and use of transporter data from non-animal methods. Overall, it was determined that a combined mechanistically-anchored in vitro-in silico approach, validated against available human data, would gain confidence in using transporter data within an animal-free risk assessment paradigm. Finally, respondents involved primarily in fundamental research expressed lower confidence in non-animal studies to unravel complex transporter mechanisms.

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Section: Discussionmentioning

confidence: 99%

Capturing the applicability of in vitro-in silico membrane transporter data in chemical risk assessment and biomedical research

Clerbaux

Coecke

Lumen

et al. 2018

Science of The Total Environment

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“…Imaging is underutilized in pharmaceutical drug development, with imaging performed on only about 1% or 2% of animals used in the preclinical stages of drug development [28]. Development of truly functional imaging methods would harness the power of regional measurements and provide added sensitivity and information for assessment of novel treatments.…”

Section: Assessment Of Inhaled Treatments Using Functional Lung Imagingmentioning

confidence: 99%

Imaging regional lung function: A critical tool for developing inhaled antimicrobial therapies

Dubsky

Fouras

2015

Advanced Drug Delivery Reviews

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Alterations in regional lung function due to respiratory infection have a significant effect on the deposition of inhaled treatments. This has consequences for treatment effectiveness and hence recovery of lung function. In order to advance our understanding of respiratory infection and inhaled treatment delivery, we must develop imaging techniques that can provide regional functional measurements of the lung. In this review, we explore the role of functional imaging for the assessment of respiratory infection and development of inhaled treatments. We describe established and emerging functional lung imaging methods. The effect of infection on lung function is described, and the link between regional disease, function, and inhaled treatments is discussed. The potential for lung function imaging to provide unique insights into the functional consequences of infection, and its treatment, is also discussed.

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“…Imaging techniques arise as complementary tools to asses new drug delivery systems [166]. Tests of biological or in vivo nature can be performed in a non invasive way, providing information that would not be available by other techniques.…”

Section: Applications In Imaging Techniquesmentioning

confidence: 99%