Xavier Palazzi, Lennart T Anger, Theresa Boulineau, Armelle Grevot, Magali Guffroy, Kristin Henson, Natalie Hoepp, Matt Jacobsen, Vijay P Kale, John Kreeger, Joan H Lane, Dingzhou Li, Wolfgang Muster, Brianna Paisley, Lila Ramaiah, Nicola Robertson, Valerie Shultz, Thomas Steger Hartmann, Richard Westhouse
The replacement of a proportion of concurrent controls by virtual controls in nonclinical safety studies has gained traction over the last few years. This is supported by foundational work, encouraged by regulators, and aligned with societal expectations regarding the use of animals in research. This paper provides an overview of the points to consider for any institution on the verge of implementing this concept, with emphasis given on database creation, risks, and discipline-specific perspectives.
April 26, 2024: Regulatory Toxicology and Pharmacology: RTP