[HTML][HTML] Opportunities for use of one species for longer-term toxicology testing during drug development: A cross-industry evaluation
H Prior, P Baldrick, S Beken, H Booler, N Bower… - Regulatory Toxicology …, 2020 - Elsevier
An international expert working group representing 37 organisations (pharmaceutical/
biotechnology companies, contract research organisations, academic institutions and
regulatory bodies) collaborated in a data sharing exercise to evaluate the utility of two
species within regulatory general toxicology studies. Anonymised data on 172 drug
candidates (92 small molecules, 46 monoclonal antibodies, 15 recombinant proteins, 13
synthetic peptides and 6 antibody-drug conjugates) were submitted by 18 organisations …
biotechnology companies, contract research organisations, academic institutions and
regulatory bodies) collaborated in a data sharing exercise to evaluate the utility of two
species within regulatory general toxicology studies. Anonymised data on 172 drug
candidates (92 small molecules, 46 monoclonal antibodies, 15 recombinant proteins, 13
synthetic peptides and 6 antibody-drug conjugates) were submitted by 18 organisations …