Rick Perry

TL;DR: The Society of Toxicologic Pathology has developed the following recommendations for the use of pathology images in compliance with the Code of Federal Regulations, Volume 21, Part 58 (Good Laboratory Practices [GLP]) and Part 11 (Electronic Records/Signatures).

TL;DR: Data on 137 compounds and 78 small molecules from 259 studies showed wide variation in where, when and why recovery animals were included, suggesting opportunities to reduce the use of recovery animals without impacting drug development.

TL;DR: The regulatory guidelines that provide for the inclusion of recovery groups in toxicology studies are reviewed, the challenges in the design and interpretation of nonclinical recovery studies are presented, and the best practices for the role of an anatomic pathologist regarding Toxicology studies with recovery groups are summarized.

TL;DR: The Society of Toxicologic Pathology (STP) as discussed by the authors describes five best practices for appropriate use of informed versus masked microscopic evaluation in animal toxicity studies intended for regulatory review, including the following: (1) Masked microscopic evaluation has merit for confirming preliminary diagnoses for target organs and/or defining thresholds identified during an initial informed evaluation, addressing focused hypotheses, or satisfying guidance or requests from regulatory agencies.