Scientific and Regulatory Policy Committee Best Practices: Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies-Reference-Cited by-同舟云学术

Scientific and Regulatory Policy Committee Best Practices: Documentation of Sexual Maturity by Microscopic Evaluation in Nonclinical Safety Studies

Published:2021-03-04 Issue:5 Volume:49 Page:977-989
ISSN:0192-6233
Container-title:Toxicologic Pathology
language:en
Short-container-title:Toxicol Pathol

Author:

Vidal Justin D.¹^ORCID,Colman Karyn²^ORCID,Bhaskaran Manoj³,de Rijk Eveline⁴,Fegley Darren⁵,Halpern Wendy⁶,Jacob Binod⁷,Kandori Hitoshi⁸,Manickam Balasubramanian⁹,McKeag Sean¹⁰,Parker George A.¹¹,Regan Karen S.¹²,Sefing Benjamin⁷,Thibodeau Michael¹³,Vemireddi Vimala¹⁴,Werner Jonathan¹⁵^ORCID,Zalewska Aleksandra¹⁶

Affiliation:

1. Charles River Laboratories, Mattawan, MI, USA

2. Novartis Institutes for BioMedical Research, San Diego, CA, USA

3. Eli Lilly & Co, Indianapolis, IN, USA

4. Charles River Laboratories, Hertogenbosch, the Netherlands

5. US FDA, Silver Spring, MD, USA

6. Genentech, South San Francisco, CA, USA

7. Merck & Co, Inc, West Point, Pennsylvania, PA, USA

8. Axcelead Drug Discovery Partners, Fujisawa, Kanagawa, Japan

9. Pfizer Inc, Groton, CT, USA

10. Covance, Harrogate, United Kingdom

11. Charles River Laboratories, Durham, NC, USA

12. Regan Path/Tox Services, Ashland, OH, USA

13. Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA

14. , Ashburn, VA, USA

15. Amgen, Thousand Oaks, CA, USA

16. Idorsia Pharmaceuticals Limited, Allschwil, Switzerland

Abstract

The sexual maturity status of animals in nonclinical safety studies can have a significant impact on the microscopic assessment of the reproductive system, the interpretation of potential test article–related findings, and ultimately the assessment of potential risk to humans. However, the assessment and documentation of sexual maturity for animals in nonclinical safety studies is not conducted in a consistent manner across the pharmaceutical and chemical industries. The Scientific and Regulatory Policy Committee of the Society of Toxicologic Pathology convened an international working group of pathologists and nonclinical safety scientists with expertise in the reproductive system, pathology nomenclature, and Standard for Exchange of Nonclinical Data requirements. This article describes the best practices for documentation of the light microscopic assessment of sexual maturity in males and females for both rodent and nonrodent nonclinical safety studies. In addition, a review of the microscopic features of the immature, peripubertal, and mature male and female reproductive system and general considerations for study types and reporting are provided to aid the study pathologist tasked with documentation of sexual maturity.

Publisher

SAGE Publications

Subject

Cell Biology,Toxicology,Molecular Biology,Pathology and Forensic Medicine

Link

http://journals.sagepub.com/doi/pdf/10.1177/0192623321990631

Reference74 articles.

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5. Scientific and Regulatory Policy Committee Points to Consider Review

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