Ensuring quality of in vitro alternative test methods: Current practice

Regulatory Toxicology and Pharmacology : RTP
Amy RispinMitchell Klausner

Abstract

In Vitro toxicology methods are being validated and adopted by regulatory agencies for use as alternatives to animal testing. Such methods may use ex vivo tissues or bioconstructs, some of which may be proprietary. Users of the data from these methods need to be reassured that the assays or assay components used in their studies provide consistent, good quality data over time, matching the standards achieved during the validation process. This paper presents an overview of approaches currently used by representatives of a manufacturer and a contract testing laboratory to ensure that the results from in vitro alternative methods are reproducible and of high quality over time. These approaches include full characterization of cells or tissues, sampling of each lot of manufactured bioconstructs for performance, and regular use of controls and benchmark chemicals to provide assurance of consistency of assay performance.

References

Sep 11, 2002·Toxicology in Vitro : an International Journal Published in Association with BIBRA·C FallerR Roguet

❮ Previous
Next ❯

Citations

Jul 15, 2009·Journal of Visualized Experiments : JoVE·Helena KandárováJohn Sheasgreen
Jun 6, 2009·Toxicology in Vitro : an International Journal Published in Association with BIBRA·Laurie ScottValérie Zuang
Mar 26, 2008·Regulatory Toxicology and Pharmacology : RTP·Ute UkelisStefan O Mueller
Aug 26, 2015·Journal of Applied Toxicology : JAT·Bhavesh K Ahir, Margaret K Pratten
Jan 29, 2010·Alternatives to Laboratory Animals : ATLA·John SheasgreenDavid Ingalls
Jan 29, 2010·Alternatives to Laboratory Animals : ATLA·Helena KandárováJohn Sheasgreen
Jan 16, 2021·In Vitro Cellular & Developmental Biology. Animal·Mitchell KlausnerSeiya Aizawa

❮ 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.

Related Papers

Drug Metabolism and Disposition : the Biological Fate of Chemicals
Sharon L RippSonia M de Morais
Nature Reviews. Drug Discovery
Ismail Kola, John Landis
Drug Metabolism and Disposition : the Biological Fate of Chemicals
Caroline AninatAndré Guillouzo
The New England Journal of Medicine
David N Juurlink
© 2022 Meta ULC. All rights reserved