Animal Testing

General chapters on pyrogens, histamine and depressor substances – involving tests on rabbits, guinea pigs and cats – are being removed from the Ph. Eur, marking another step in the European Pharmacopoeia Commission’s ongoing efforts to replace, reduce and refine the use of animals for monograph requirements.

This is Part 1 of a 2-part profile of Hans Clevers, Head of Pharma Research and Early Development at Roche.

New alternative methods to animal testing in early drug development are increasing in sophistication and predictability, yet they are vastly underutilized. In Vivo presents an overview of select technologies and vendors.

Slow adoption of alternatives to animal testing in the current decentralized regulatory framework.

This week, two device testing labs in China landed FDA warning letters; refunds for 1Health.io clients; FDA AR/VR product list expands. 

Despite increased openness by regulators and technological progress, the adoption of alternatives to animal testing remains challenging. The need for data validation by agencies and companies is a big factor.

AI modeling can predict which animal tests are useful and necessary, saving money for companies and meeting objectives set by regulators in the US and EU, VeriSIM Life’s CEO and founder Jo Varshney tells the Pink Sheet.

In addition to sustainability, Myers noted DEI and advancing alternatives to animal testing among key priorities for the group. “We have member companies that really lead the way on many of those. We want to be able to amplify their good work and their messaging, because they are good corporate citizens” and “it’s what consumers are demanding anyway,” he said in an interview.

The use of the RPT is to no longer be required in any text of the European Pharmacopoeia and medicine developers will have to select a suitable in vitro test to control the pyrogenicity of their product.

Animal advocacy group PETA claims documents recently made public on listening sessions between the US Food and Drug Administration and sunscreen manufacturers show FDA is ‘checking a box by pushing decades-old animal tests rather than using modern science’ to assess the safety of sunscreens, despite the agency’s claims that it is encouraging non-animal methods.