Safer Medicines - putting patient safety first

Putting patient safety first

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Latest News

Is it possible to overcome issues of external validity in preclinical animal research? Why most animal models are bound to fail

New article by Dr Pandora Pound and Professor Merel Ritskes-Hoitinga published in Journal of Translational Medicine

The authors make a compelling argument that preclinical animal models can never be fully valid due to the uncertainties introduced by species differences. They suggest that to improve clinical translation and ultimately benefit patients, research should focus instead on human-relevant research methods and technologies.

Read the full paper here

 


Human cell-based assays vital to assess risk of drug-induced liver injury

New review article coauthored by Dr Gerry Kenna published in the journal Clinical Pharmacology & Therapeutics:

Can BSEP Inhibition Testing In Drug Discovery And Development Reduce Liver Injury Risk? An International Transporter Consortium Perspective

Medicines can cause serious unwanted side effects in some patients. These include drug-induced liver injury (DILI), which is poorly predicted by the currently used safety test methods. Assays that focus on human-relevant mechanisms can provide more useful data. One important mechanism is inhibition of a liver cell membrane transport protein called the Bile Salt Export Pump (BSEP). This article reviews the evidence linking BSEP inhibition with DILI and describes methods to evaluate and interpret BSEP inhibition. It also recommends how these data can be used to aid the design and selection of safer medicines. The authors from Safer Medicines Trust, major pharmaceutical companies, universities and biotechnology companies were brought together by the International Transporter Consortium.


Predicting drug-induced liver injury risk


New paper published in the journal Drug Metabolism and Disposition: Do In Vitro Assays Predict Drug Candidate Idiosyncratic Drug-Induced Liver Injury Risk?

Our Pharmaceutical Director, Dr Gerry Kenna co-authored the paper with Dr Jack Uetrecht, Professor of Pharmacy and Medicine at the University of Toronto and the Canada Research Chair in Adverse Drug Reactions

Many new medicines cause undesired side effects in humans that are not predicted by the drug safety studies performed currently. This review focuses on liver injury, which is an especially important human adverse drug effect. It highlights both the promising progress made in developing human-relevant in vitro methods that can anticipate and reduce drug induced liver injury risk, and outstanding challenges which remain to be addressed.


Dr Pandora Pound guest blogs for Animals in Science Policy Institute

Our Research Consultant, Dr Pandora Pound, gives a fascinating insight into the introduction of the use of systematic reviews in preclinical animal research, in which she played an instrumental role.

Systematic reviews have become accepted as powerful tools that should be deployed routinely to improve the quality of the evidence base in clinical research. Although their use is not yet routine in preclinical research, they have been instrumental in provoking debate about the reliability, validity, and value of preclinical animal research.

Read the article: The problem of evidence in pre-clinical animal research: how systematic reviews can help


See more news here.

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