Recommendation on test readiness criteria for new approach methods in toxicology: Exemplified for developmental neurotoxicity

ALTEX
Anna Bal-PriceMarcel Leist

Abstract

Multiple non-animal-based test methods have never been formally validated. In order to use such new approach methods (NAMs) in a regulatory context, criteria to define their readiness are necessary. The field of developmental neurotoxicity (DNT) testing is used to exemplify the application of readiness criteria. The costs and number of untested chemicals are overwhelming for in vivo DNT testing. Thus, there is a need for inexpensive, high-throughput NAMs, to obtain initial information on potential hazards, and to allow prioritization for further testing. A background on the regulatory and scientific status of DNT testing is provided showing different types of test readiness levels, depending on the intended use of data from NAMs. Readiness criteria, compiled during a stakeholder workshop, uniting scientists from academia, industry and regulatory authorities are presented. An important step beyond the listing of criteria, was the suggestion for a preliminary scoring scheme. On this basis a (semi)-quantitative analysis process was assembled on test readiness of 17 NAMs with respect to various uses (e.g. prioritization/screening, risk assessment). The scoring results suggest that several assays are currently at high readiness leve...Continue Reading

Citations

Jan 1, 2019·Environmental Sciences Europe·J B LegradiH Hollert
Aug 25, 2019·Archives of Toxicology·Nicoleta SpinuAndrew P Worth
Apr 9, 2020·Frontiers in Neurology·Linda OttoboniGianvito Martino
Feb 26, 2020·Environmental Health : a Global Access Science Source·Francesca PistollatoAnna Bal-Price
Mar 1, 2019·Toxicological Sciences : an Official Journal of the Society of Toxicology·Timothy J ShaferKatie Paul Friedman
Jul 7, 2020·EFSA Journal·Anna LanzoniMaged Younes
Jun 5, 2020·International Journal of Molecular Sciences·Diana LupuJoëlle Rüegg
Jan 6, 2021·Environment International·Maryam Zare JeddiRobert Pasanen-Kase
Sep 20, 2020·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Shotaro KamataIsao Ishii
Feb 16, 2021·Expert Opinion on Drug Metabolism & Toxicology·Emma E J Kasteel, Remco H S Westerink
Feb 5, 2021·Toxicological Sciences : an Official Journal of the Society of Toxicology·Joshua A HarrillRichard S Judson
Nov 5, 2020·Reproductive Toxicology·Manuela JaklinStefan Kustermann
May 11, 2021·Cell Biology and Toxicology·Jördis KloseEllen Fritsche
Jul 13, 2021·Lab on a Chip·Monica PiergiovanniMaurice Whelan
Sep 1, 2021·Critical Reviews in Toxicology·Marlon R SchneiderRob J Vandebriel
Nov 9, 2021·Cytometry. Part a : the Journal of the International Society for Analytical Cytology·Nils FörsterAxel Mosig

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.