American College of Toxicology and Society of Toxicologic Pathology Collaboration Webinar
Speakers: Christopher J. Bowman, PhD, DABT, Associate Research Fellow, Pfizer Worldwide R&D and Wendy G. Halpern, DVM, PhD, DACVP, Principal Pathologist, Genentech, Inc.
Standard components of nonclinical toxicity testing for novel pharmaceuticals include clinical and anatomic pathology, as well as separate evaluation of effects on reproduction and development to inform clinical development and labeling. General study designs in regulatory guidances do not specifically mandate use of pathology or reproductive end points across all study types; thus, inclusion and use of these end points are variable. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology (STP) formed a Working Group to assess the current guidelines and practices on the use of reproductive, anatomic pathology, and clinical pathology end points in general, reproductive, and developmental toxicology studies. The Working Group constructed a survey sent to pathologists and reproductive toxicologists, and responses from participating organizations were collected through the STP for evaluation by the Working Group. The regulatory context, relevant survey results, and collective experience of the Working Group are discussed and provide the basis of each assessment by study type. Overall, the current practice of including specific end points on a case-by-case basis is considered appropriate. Points to consider are summarized for inclusion of reproductive end points in general toxicity studies and for the informed use of pathology end points in reproductive and developmental toxicity studies.
View Webinar Recording
Webinar materials are property of the speaker and the American College of Toxicology and are intended for use by the host society and cohost societies' members for educational purposes only. Any distribution or copy of the materials is prohibited. By downloading from the link provided you agree to the terms expressed above.