title: Considerations for conducting imaging studies in support of developmental toxicology studies for regulatory submission.
abstract: Preclinical imaging technologies are increasingly being applied to developmental toxicology studies in drug development to determine potential compound toxicity. Although most of these studies are conducted in a non-regulatory setting, there is interest in performing these imaging studies under applicable regulations, for example Good Laboratory Practices (GLP), to support regulatory decisions concerning drug safety. This manuscript will describe regulations and processes to consider when bringing an imaging technology into GLP compliance.
authors.affiliation: Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., West Point, PA, United States. Electronic address: colena_johnson@merck.com.
authors.forename: Colena A
authors.initials: CA
authors.lastname: Johnson
authors.affiliation: Imaging Department, Merck & Co., Inc., West Point, PA, United States.
authors.forename: Christopher T
authors.initials: CT
authors.lastname: Winkelmann
authors.affiliation: Safety Assessment and Laboratory Animal Resources, Merck & Co., Inc., West Point, PA, United States.
authors.forename: L David
authors.initials: LD
authors.lastname: Wise
mesh_terms: D000818:Animals; D003952:Diagnostic Imaging / Q000295:instrumentation; D017277:Drug Approval; D004353:Drug Evaluation, Preclinical; D006077:Government Agencies; D011786:Quality Control; D014116:Toxicology / Q000295:instrumentation / Q000379:methods*
keywords: CT; GLP; ICH; Reproductive toxicology; SEND; Validation