Complex in vitro models positioned for impact to drug testing in pharma: a review DOI Creative Commons
Michael S. Kang, Eugene C. Chen, Helen Cifuentes

и другие.

Biofabrication, Год журнала: 2024, Номер 16(4), С. 042006 - 042006

Опубликована: Авг. 27, 2024

Abstract Recent years have seen the creation and popularization of various complex in vitro models (CIVMs), such as organoids organs-on-chip, a technology with potential to reduce animal usage pharma while also enhancing our ability create safe efficacious drugs for patients. Public awareness CIVMs has increased, part, due recent passage FDA Modernization Act 2.0. This visibility is expected spur deeper investment adoption models. Thus, end-users model developers alike require framework both understand readiness current enter drug development process, assess upcoming same. review presents selection based on comparative -omics data (which we term model-omics), metrics qualification specific test assays that may support context-of-use (COU) assays. We surveyed existing healthy tissue ten development-critical organs body, provide evaluations suggestions improving model-omics COU each. In whole, this comes from perspective, seeks an evaluation where are poised maximum impact roadmap realizing potential.

Язык: Английский

Biocosmetics: technological advances and future outlook DOI Open Access
Nishu Goyal,

Frankline Jerold

Environmental Science and Pollution Research, Год журнала: 2021, Номер 30(10), С. 25148 - 25169

Опубликована: Ноя. 25, 2021

Язык: Английский

Процитировано

116

Application of AOPs to assist regulatory assessment of chemical risks – Case studies, needs and recommendations DOI Creative Commons
Lola Bajard, Ondřej Adamovský, Karine Audouze

и другие.

Environmental Research, Год журнала: 2022, Номер 217, С. 114650 - 114650

Опубликована: Окт. 26, 2022

While human regulatory risk assessment (RA) still largely relies on animal studies, new approach methodologies (NAMs) based in vitro, silico or non-mammalian alternative models are increasingly used to evaluate chemical hazards. Moreover, epidemiological studies with biomarkers of effect (BoE) also play an invaluable role identifying health effects associated exposures. To move towards the next generation (NGRA), it is therefore crucial establish bridges between NAMs and standard approaches, processes for increasing mechanistically-based biological plausibility studies. The Adverse Outcome Pathway (AOP) framework constitutes important tool address these needs but, despite a significant increase knowledge awareness, use AOPs RA remains limited. objective this paper issues related using context from various perspectives as was discussed workshop organized within European Union partnerships HBM4EU PARC spring 2022. presents examples where AOP has been proven useful process, particularly hazard prioritization characterization, integrated approaches testing (IATA), identification validation BoE Nevertheless, several limitations were identified that hinder optimal usability acceptance by community including lack quantitative information response-response relationships efficient ways map data (exposure toxicity) onto AOPs. summarizes suggestions, ongoing initiatives third-party tools may help overcome obstacles thus assure better implementation NGRA.

Язык: Английский

Процитировано

70

Implementing New Approach Methodologies (NAMs) in food safety assessments: Strategic objectives and actions taken by the European Food Safety Authority DOI Creative Commons
Irene Cattaneo, Maria Chiara Astuto,

Marco Binaglia

и другие.

Trends in Food Science & Technology, Год журнала: 2023, Номер 133, С. 277 - 290

Опубликована: Фев. 8, 2023

New Approach Methodologies (NAMs) comprise in silico and vitro methods applied as alternative to animal testing. Even though NAMs are already fully implemented research tools, their use regulatory risk assessments (RA) is limited currently. To promote the uptake/acceptance of NAMs, a paradigm shift assessment approaches, proper dialogue between assessors managers needed. Several reviews addressed for chemical RA generic terms, but without providing specific considerations on food/feed safety assessments. Therefore, this review, we give insights potential purposes EU. We summarise relevant projects activities coordinated by European Food Safety Authority (EFSA), which agency Union that contributes food feed chain. The review informs future developments human health RA, touches protein toxicity allergenicity, well environmental risks. Reducing testing filling some gaps via almost reality. Moreover, there growing body evidence confirming inclusion mechanistic information improves EFSA's address main challenge using intermediate effects observed non-animal models assessments, especially those linked adverse insufficiently covered or uncovered apical endpoints.

Язык: Английский

Процитировано

44

Replacement of animal testing by integrated approaches to testing and assessment (IATA): a call for in vivitrosi DOI Creative Commons
F. Caloni, I. De Ange̊lis, Thomas Härtung

и другие.

Archives of Toxicology, Год журнала: 2022, Номер 96(7), С. 1935 - 1950

Опубликована: Май 3, 2022

Abstract Alternative methods to animal use in toxicology are evolving with new advanced tools and multilevel approaches, answer from one side 3Rs requirements, on the other offering relevant valid tests for drugs chemicals, considering also their combination test strategies, a proper risk assessment. While stand-alone methods, have demonstrated be applicable some specific toxicological predictions limitations, strategy application of New Approach Methods (NAM), solve complex endpoints is addressed by Integrated Approaches Testing Assessment (IATA), aka Strategies (ITS) or Defined (DA). The central challenge evidence integration shared needs assessment systematic reviews an evidence-based Toxicology. Increasingly, machine learning (aka Artificial Intelligence, AI) lends itself integrate diverse streams. In this article, we give overview state art alternative IATA regulatory various hazards, outlining future orientation perspectives. We call leveraging synergies integrated approaches vivo, vitro silico as true vivitrosi.

Язык: Английский

Процитировано

42

Regulatory safety assessment of nanoparticles for the food chain in Europe DOI Creative Commons
Reinhilde Schoonjans, Jacqueline Castenmiller,

Qasim Chaudhry

и другие.

Trends in Food Science & Technology, Год журнала: 2023, Номер 134, С. 98 - 111

Опубликована: Фев. 3, 2023

The risk assessment of small particles (including nanoparticles) in products used the food chain EU falls within remit European Food Safety Authority (EFSA) and has been under thorough scientific considerations for over a decade. Now that more experience is gained with evaluating novel foods, contact materials, food/feed additives pesticides, outlines regulatory safety assessments data requirements are established. This paper reviews principles underlying testing particles, referring to two recently published EFSA guidance documents. Examples observations from assessing existing materials provided facilitate wider readership adequate implementation requirements. starting point physicochemical characterisation pristine material, being an engineered nanomaterial, nanostructured material or conventional contains fraction may retain properties at nanoscale. Key parameters threshold values establishing presence techniques methods complex matrices, as well approaches dietary exposure outlined. Where there likelihood remaining after gastrointestinal digestion, hazard identification required special provisions. In particular, certain nano-specific highlighted have be considered during toxicological aim demonstrate consumer Europe.

Язык: Английский

Процитировано

36

Endocrine Disruptor Compounds in Environment: Focus on Women’s Reproductive Health and Endometriosis DOI Open Access

Livia Interdonato,

Rosalba Siracusa, Roberta Fusco

и другие.

International Journal of Molecular Sciences, Год журнала: 2023, Номер 24(6), С. 5682 - 5682

Опубликована: Март 16, 2023

Endometriosis is an estrogen-dependent gynecologic illness that has long-term effects on a woman’s fertility, physical health, and overall quality of life. Growing evidence suggests endocrine-disrupting chemicals (EDCs) may be etiologically involved in the development severity disease. We consider available human EDCs endometriosis, limiting ourselves to studies have individually assessed chemical amounts women. Dioxins, BPA, Phthalates, other endocrine disruptors, like DDT, are among indicating environmental etiology for endometriosis. Collectively, this review describes how toxins linked lower fertility women, as well number reproductive diseases, focusing pathology endometriosis its treatments. Importantly, can used investigate techniques preventing negative EDC exposure.

Язык: Английский

Процитировано

34

Dermal bioavailability of perfluoroalkyl substances using in vitro 3D human skin equivalent models DOI Creative Commons
Oddný Ragnarsdóttir, Mohamed Abou‐Elwafa Abdallah, Stuart Harrad

и другие.

Environment International, Год журнала: 2024, Номер 188, С. 108772 - 108772

Опубликована: Май 23, 2024

Perfluoroalkyl substances (PFAS) have been identified in various products that come contact with human skin, ranging from school uniforms to personal care products. Despite this, knowledge on dermal uptake of PFAS is lacking. Thus, the absorption 17 was assessed, for first time, using vitro 3D-human skin equivalent models exposed 500 ng/cm

Язык: Английский

Процитировано

13

Current and emerging issues in chemical food safety DOI
Chen Liu, Danlei Wang, Ivonne M.C.M. Rietjens

и другие.

Current Opinion in Food Science, Год журнала: 2025, Номер unknown, С. 101284 - 101284

Опубликована: Фев. 1, 2025

Язык: Английский

Процитировано

2

Safety Testing of Cosmetic Products: Overview of Established Methods and New Approach Methodologies (NAMs) DOI Creative Commons

Manon Barthe,

Clarisse Bavoux,

F. Finot

и другие.

Cosmetics, Год журнала: 2021, Номер 8(2), С. 50 - 50

Опубликована: Июнь 11, 2021

Cosmetic products need to have a proven efficacy combined with comprehensive toxicological assessment. Before the current regulation N°1223/2009, 7th Amendment European Cosmetics Directive has banned animal testing for cosmetic and ingredients in 2004 2009, respectively. An increasing number of alternatives been developed validated safety ingredients. For example, 2D cell culture models derived from human skin can be used evaluate anti-inflammatory properties, or predict sensitization potential; 3D equivalent are irritation excised is as gold standard evaluation dermal absorption. The aim this manuscript give an overview main vitro ex vivo alternative focus on regulatory requirements, genotoxicity potential, eye irritation, endocrine Advantages limitations each model discussed novel technologies capable addressing these presented.

Язык: Английский

Процитировано

44

A review of in silico toxicology approaches to support the safety assessment of cosmetics-related materials DOI Creative Commons
Mark T.D. Cronin, Steven J. Enoch, Judith C. Madden

и другие.

Computational Toxicology, Год журнала: 2022, Номер 21, С. 100213 - 100213

Опубликована: Янв. 7, 2022

In silico tools and resources are now used commonly in toxicology to support the "Next Generation Risk Assessment" (NGRA) of cosmetics ingredients or materials. This review provides an overview approaches that applied assess exposure hazard a cosmetic ingredient. For both exposure, databases existing information routinely. addition, for include use rules thumb systemic bioavailability as well physiologically-based kinetics (PBK) multi-scale models estimating internal at organ tissue level. (Internal) Thresholds Toxicological Concern applicable safety assessment low concentrations. The structural rules, (Quantitative) Structure-Activity Relationships ((Q)SARs) read-across most typically modelling predict hazard. Data from increasingly being brought together NGRA provide overall All reviewed terms their maturity robustness use.

Язык: Английский

Процитировано

32