Scientific and Regulatory Policy Committee (SRPC) Paper

Andersson, Håkan H. A. S.; Rehm, Sabine; Stanislaus, Dinesh; Wood, Charles E.

doi:10.1177/0192623312466959

Cited by 39 publications

(28 citation statements)

References 96 publications

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“…The number of animals needed to detect a difference in hormones is often severely under-estimated. This topic has recently been addressed in several publications (Stanislaus et al , 2012, Chapin and Creasy, 2012, Andersson et al , 2013). …”

Section: Inclusion Of Reproductive Endpoints In General Toxicity Smentioning

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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Section: Inclusion Of Reproductive Endpoints In General Toxicity Smentioning

confidence: 99%

Scientific and Regulatory Policy Committee Points to Consider Review

Halpern¹,

Ameri

Bowman

et al. 2016

Toxicol Pathol

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show abstract

“…For the thyroid hormones and TSH, see the exemplary calculation above and in Table A.1 of Appendix B in ED Guidance document (ECHA and EFSA et al 2018). For male and female reproductive hormones, power analysis calculations can be found elsewhere (Andersson et al 2013;Stanislaus et al 2012).…”

Section: General Recommendations For Assessing Circulating Hormones (mentioning

confidence: 99%

“…LH, testosterone). For more specific recommendations on the design of male and female reproductive hormone measurements, reviews by the Scientific and Regulatory Policy Committee might be helpful (Andersson et al 2013;Chapin and Creasy 2012).…”

Section: Considerations Relevant To the Study Designmentioning

confidence: 99%

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Report from the BfR expert hearing on practicability of hormonal measurements: recommendations for experimental design of toxicological studies with integrated hormonal end points

et al. 2019

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This publication summarizes discussions that were held during an international expert hearing organized by the German Federal Institute for Risk Assessment (BfR) in Berlin, Germany, in October 2017. The expert hearing was dedicated to providing practical guidance for the measurement of circulating hormones in regulatory toxicology studies. Adequate measurements of circulating hormones have become more important given the regulatory requirement to assess the potential for endocrine disrupting properties for all substances covered by the plant protection products and biocidal products regulations in the European Union (EU). The main focus was the hypothalamus-pituitary-thyroid axis (HPT) and the hypothalamuspituitary-gonadal axis (HPG). Insulin, insulin-like growth factor 1 (IGF-1), parathyroid hormone (PTH) and vitamins A and D were also discussed. During the hearing, the experts agreed on specific recommendations for design, conduct and evaluation of acceptability of studies measuring thyroid hormones, thyroid stimulating hormone and reproductive hormones as well as provided some recommendations for insulin and IGF-1. Experts concluded that hormonal measurements as part of the test guidelines (TGs) of the Organisation for Economic Cooperation and Development (OECD) were necessary on the condition that quality criteria to guarantee reliability and reproducibility of measurements are adhered to. Inclusion of the female reproductive hormones in OECD TGs was not recommended unless the design of the study was modified to appropriately measure hormone concentrations. The current report aims at promoting standardization of the experimental designs of hormonal assays to allow their integration in OECD TGs and highlights research needs for better identification of endocrine disruptors using hormone measurements.

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“…Thus, female reproductive hormonal measurements should not generally be included in first-tier toxicity studies of standard design with groups of unsynchronized intact female animals. Rather, appropriately designed and statistically powered investigative studies are recommended in order to properly identify ovarian and/or pituitary hormone changes and bridge these effects to mechanistic evaluations and safety assessments” (Andersson et al 2013). …”

Section: The Pubertal Development and Thyroid Function Assay In Femalmentioning

confidence: 99%

Scientific and Regulatory Policy Committee (SRPC) Points to Consider

Keane¹,

Parker²,

Regan

et al. 2015

Toxicol Pathol

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The U.S. Environmental Protection Agency Endocrine Disruptor Screening Program (EDSP) is a multitiered approach to determine the potential for environmental chemicals to alter the endocrine system. The Pubertal Development and Thyroid Function in Intact Juvenile/Peripubertal Female and Male Rats (OPPTS 890.1450, 890.1500) are 2 of the 9 EDSP tier 1 test Guidelines, which assess upstream mechanistic pathways along with downstream morphological end points including histological evaluation of the kidneys, thyroid, and select male/female reproductive tissues (ovaries, uterus, testes, and epididymides). These assays are part of a battery of in vivo and in vitro screens used for initial detection of test article endocrine activity. In this Points to Consider article, we describe tissue processing, evaluation, and nomenclature to aid in standardization of assay results across laboratories. Pubertal assay end points addressed include organ weights, estrous cyclicity, clinical pathology, hormonal assays, and histological evaluation. Potential treatment-related findings that may indicate endocrine disruption are reviewed. Additional tissues that may be useful in assessment of endocrine disruption (vagina, mammary glands, and liver) are discussed. This Points to Consider article is intended to provide information for evaluating peripubertal tissues within the context of individual assay end points, the overall pubertal assay, and tier I assays of the EDSP program.

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Scientific and Regulatory Policy Committee (SRPC) Paper

Cited by 39 publications

References 96 publications

Scientific and Regulatory Policy Committee Points to Consider Review

Scientific and Regulatory Policy Committee Points to Consider Review

Report from the BfR expert hearing on practicability of hormonal measurements: recommendations for experimental design of toxicological studies with integrated hormonal end points

Scientific and Regulatory Policy Committee (SRPC) Points to Consider

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