Developmental and Reproductive Toxicity Testing

Weinbauer, Gerhard F.; Bowman, Christopher J.; Halpern, Wendy; Chellman, Gary J.

doi:10.1016/b978-0-12-417144-2.00025-1

Cited by 2 publications

(3 citation statements)

References 57 publications

(82 reference statements)

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“…Most toxicologic pathologists are unlikely to encounter post‐menopausal NHPs unless specifically working on animal models of aging. NHPs typically reach menopause after 20 years of age (30 years was reported by Weinbauer, ) and the pattern of changes related to cessation of menstrual cyclicity has been previously described (Shideler et al, ; Kavanagh et al, ; Buse et al, ). Unlike rodents, the primary underlying cause is reduced follicular reserves that lead to ovarian atrophy in primates (Buse et al, ).…”

Section: Functional Aspects Of Female Reproductive System Developmentmentioning

confidence: 83%

Species Comparison of Postnatal Development of the Female Reproductive System

Laffan

Posobiec

Uhl

et al. 2017

Birth Defects Research

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The postnatal development of the female reproductive system in laboratory animals and humans is reviewed. To enable a meaningful species comparison of the developing female reproductive system, common definitions of developmental processes were established with a focus made on aspects that are similar across species. A species comparison of the key endocrine, morphologic, and functional (onset of ovarian cycles and ability to reproduce) features of postnatal development of the female reproductive system is provided for human, nonhuman primate, dog, rat, and also mouse, minipig, and rabbit where possible. Species differences in the timing and control of female sexual maturation are highlighted. Additionally, a species comparison of the type and timing of female reproductive ovarian cycles was compiled. Human development provided the frame of reference, and then other common laboratory species were compared. The comparison has inherent challenges because the processes involved and sequence of events can differ greatly across species. Broad strokes were taken to assign a particular average age to an event and are to be used with caution. Methods of evaluation of postnatal female reproductive development in laboratory animals are discussed. Lastly, control rodent data from one of the author's laboratory on vaginal opening, first estrus, estrous cyclicity, and the histopathology involved with the developing female rat and mouse are presented. The information provided in this review is intended to be a resource for the design and interpretation of juvenile animal toxicity testing and ultimately, the relevance of the data to characterize potential risks for women and girls. Birth Defects Research 110:163-189, 2018. © 2017 Wiley Periodicals, Inc.

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Section: Functional Aspects Of Female Reproductive System Developmentmentioning

confidence: 83%

Species Comparison of Postnatal Development of the Female Reproductive System

Laffan

Posobiec

Uhl

et al. 2017

Birth Defects Research

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“…When necessary, a weight of evidence approach using observations of serial menses prior to study initiation may be warranted. One approach is to require at least 2 cycles of at least 2 days duration and at least 20 days apart when selecting mature females (Weinbauer et al , 2015). …”

Section: Inclusion Of Reproductive Endpoints In General Toxicity Smentioning

confidence: 99%

“…There are not many recently published examples of rodent PPND studies in the literature, but a recently published compilation of NHP developmental toxicity studies provides examples of PPND studies that included pathology endpoints (Weinbauer et al , 2015). …”

Section: Inclusion Of Pathology Endpoints In Reproductive Toxicitymentioning

confidence: 99%

Scientific and Regulatory Policy Committee Points to Consider Review

Halpern¹,

Ameri

Bowman

et al. 2016

Toxicol Pathol

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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 endpoints across all study types; thus, inclusion and use of these endpoints are variable. The Scientific and Regulatory Policy Committee (SRPC) 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 endpoints 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 endpoints on a case-by-case basis is considered appropriate. Points to consider are summarized for inclusion of reproductive endpoints in general toxicity studies, and for the informed use of pathology endpoints in reproductive and developmental toxicity studies.

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Developmental and Reproductive Toxicity Testing

Cited by 2 publications

References 57 publications

Species Comparison of Postnatal Development of the Female Reproductive System

Species Comparison of Postnatal Development of the Female Reproductive System

Scientific and Regulatory Policy Committee Points to Consider Review

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