Regulatory Forum Opinion Piece*: An Experienced Pathologist Need Not Always Be Present at Necropsy for Small Molecule or Biotherapeutic Safety Studies

摘要

It is the author's opinion that an experienced pathologist need not always be present at necropsy for safety studies to support development of large or small molecules. Reasons why an experienced pathologist need not be present in the room for every study as well as the value of necropsy attendance as a training opportunity for less experienced pathologists are presented. However, there are studies for which an experienced pathologist should be in attendance at necropsy and examples of these types of studies are listed.