CYTO 2023 -- Chimeric antigen receptor T-cells (CAR-T) are an exciting area of therapeutics that are rapidly expanding into broader disease indications with the development of increasingly sophisticated and elegant CAR-T designs.

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A recent European Chemicals Agency (ECHA) review project regarding the design of the OECD 443 (Extended One-Generation Reproductive Toxicity Study or EOGRTS) aimed to assess the performance of the study in terms of study design, conduct and findings to determine if the study design currently prescribed gives sufficient information for regulatory hazard cla

ISSX-DMDG 2023 -- With the intensified regulatory and industry focus on the design and conduct of human absorption, metabolism and excretion (hAME) studies in the past 12 months, we have recently completed our 500th cohort involving radiolabelled test item administration to humans.

ISSX-DMDG 2023 -- Idiosyncratic drug-induced liver injury (DILI) is a major cause of safety-related drug withdrawal post-market for small molecule medications and a major cause of attrition during drug development. Prediction of DILI remains difficult, and the underlying mechanisms are not fully understood.

UKEMS 2023 -- The OECD 488 test guideline (TG488) on Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays was first adopted in July 2011 and has been revised periodically in July 2013, June 2020 and most recently in June 2022. This guideline describes the use of a variety of transgenic rodent models to reliably measure gene mutations in vivo.

UKEMS 2023 -- The in vivo phosphatidylinositol glycan class A (Pig-a) gene mutation assay is based on the endogenous X-linked Pig-a gene, which codes for an N-acetyl glucosamine transferase that is involved in the biosynthesis of glycosyl phosphatidyl inositol (GPI) anchor for tethering a variety of mammalian cell surface protein markers.

UKEMS 2023 -- The Bhas 42 cell promoter transformation assay is a sensitive short-term system for predicting chemical carcinogenicity related to transformation promotion activity. Bhas 42 cells were established from BALB/c 3T3 A31-1-1 cells by the transfection of v‑Ha‑ras gene.