A model for human and animal data integration: Weight of evidence strategy-Reference-Cited by-同舟云学术

A model for human and animal data integration: Weight of evidence strategy

Published:2020-08-07 Issue:18 Volume:112 Page:1505-1512
ISSN:2472-1727
Container-title:Birth Defects Research
language:en
Short-container-title:Birth Defects Research

Author:

Wurst Keele E.¹^ORCID,Sumner Kelsey M.¹²,Stanislaus Dinesh³,Powell Marcy⁴,Cunnington Marianne¹

Affiliation:

1. Epidemiology Value Evidence Outcomes, GlaxoSmithKline, Uxbridge UK Research Triangle Park North Carolina USA

2. Department of Epidemiology University of North Carolina, Gillings School of Global Public Health Chapel Hill North Carolina USA

3. Reproductive Toxicology GlaxoSmithKline Collegeville Pennsylvania USA

4. Safety and Medical Governance GlaxoSmithKline, Research Triangle Park North Carolina USA

Publisher

Wiley

Subject

Health, Toxicology and Mutagenesis,Developmental Biology,Toxicology,Embryology,Pediatrics, Perinatology, and Child Health

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1002/bdr2.1775

Reference25 articles.

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3. European Medicines Agency. (2005).Guideline on the exposure to medicinal products during pregnancy: Need for post‐authorisation data. Retrieved fromhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-exposure-medicinal-products-during-pregnancy-need-post-authorisation-data_en.pdf

4. European Medicines Agency. (2008).Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling. Retrieved fromhttps://www.ema.europa.eu/en/documents/scientific-guideline/guideline-risk-assessment-medicinal-products-human-reproduction-lactation-data-labelling_en.pdf

5. Food and Drug Administration. (2005). Reviewer guidance on evaluating the risks of drug exposure in human pregnancies. Retrieved fromhttps://www.fda.gov/regulatory-information/search-fda-guidance-documents/evaluating-risks-drug-exposure-human-pregnancies

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