Value of preclinical systematic reviews and meta-analyses in pediatric research

O Romantsik, M Bank, JML Menon, A Malhotra… - Pediatric …, 2024 - nature.com
Similar to systematic reviews (SRs) in clinical fields, preclinical SRs address a specific
research area, furnishing information on current knowledge, possible gaps, and potential …

Weight of Evidence: Is an Animal Study Warranted? Assessments for Carcinogenicity, Drug Abuse Liability, and Pediatric Safety

T Ramani, RL Wange, TS Manetz… - International …, 2024 - journals.sagepub.com
Nonclinical safety studies are typically conducted to establish a toxicity profile of a new
pharmaceutical in clinical development. Such a profile may encompass multiple differing …

Neuropathology evaluation in juvenile toxicity studies in rodents: comparison of developmental neurotoxicity studies for chemicals with juvenile animal studies for …

B Bolon, LA Dostal, RH Garman - Toxicologic Pathology, 2021 - journals.sagepub.com
The developmental neuropathology examination in juvenile toxicity studies depends on the
nature of the product candidate, its intended use, and the exposure scenario (eg, dose …

Juvenile Toxicology

V Vrolyk, C Tremblay, CA Picut - Drug Discovery and Evaluation: Safety …, 2024 - Springer
Juvenile toxicology encompasses the design, conduct, evaluation, and interpretation of
studies conducted in juvenile laboratory animals with the goal of assessing the safety of …

Regulatory perspectives on juvenile animal toxicologic pathology

DB Rao, AM Hoberman, PC Brown… - Toxicologic …, 2021 - journals.sagepub.com
The Society of Toxicologic Pathology's Annual Virtual Symposium (2021) included a session
on" Regulatory Perspectives on Juvenile Animal Toxicologic Pathology." The following …

The Role of Pathology in Evaluation of Reproductive, Developmental, and Juvenile Toxicity

CJ Bowman, WG Halpern - Haschek and Rousseaux's Handbook of …, 2022 - Elsevier
Drug and chemical product labels are expected to specifically address risks to special
populations such as pregnant women and children and are expected to highlight potential …