The use of human tissue in safety assessment

Journal of Pharmacological and Toxicological Methods
Samuel J JacksonAnthony Holmes

Abstract

The safety-related failure of drugs during clinical phases of development is a significant contributor to drug attrition, wasting resources and preventing treatments from reaching patients. A lack of concordance between results from animal models and adverse events in the clinic has been identified as one potential cause of attrition. In vitro models using human tissue or cells have the potential to replace some animal models and improve predictivity to humans. To gauge the current use of human tissue models in safety pharmacology and the barriers to greater uptake, an electronic survey of the international safety assessment community was carried out and a Safety Pharmacology Society European Regional Meeting was organised entitled 'The Use of Human Tissue in Safety Assessment'. A greater range of human tissue models is in use in safety assessment now than four years ago, although data is still not routinely included in regulatory submissions. The barriers to increased uptake of the models have not changed over that time, with inadequate supply and characterisation of tissue being the most cited blocks. Supporting biobanking, the development of new human tissue modelling technology, and raising awareness in the scientific and r...Continue Reading

Citations

Dec 11, 2019·Current Pharmaceutical Biotechnology·Najah Abi-GergesAndre Ghetti
Jun 29, 2021·Biosafety and Health·Julie RouxZisis Kozlakidis

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