Analysis of exposure margins in developmental toxicity studies for detection of human teratogens

Autor: Joseph J. DeGeorge, Paul A. Andrews, José A. Lebrón, Maia L. Green, Diann Blanset, Britta A. Mattson, Luana de Castro Oliveira, Daniel Minck, Peter T. Theunissen, Rajkumar Kadaba, Abigail Jacobs, Martin D. Green, Priscila Lemos Costa, Mary Ellen McNerney

Publikováno v: Regulatory toxicology and pharmacology : RTP. 105

The draft Step 2 ICH S5(R3) guideline includes an exposure-based endpoint as an option for selecting the high-dose in reproductive and developmental toxicity studies. To help determine an appropriate exposure margin for embryofetal developmental toxi

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::8a3209fa2b180399a4985b5451dc84fc
https://pubmed.ncbi.nlm.nih.gov/30981719

Alternative Methods Used to Assess Potential Embryo-Fetal Developmental Risk of Pharmaceuticals

Autor: Kimberly C. Brannen, Maia L. Green, Joshua T. Gamse

Publikováno v: Methods in Pharmacology and Toxicology ISBN: 9781493972067

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::320afc4170fa23f3f5ea72bedfe0839a
https://doi.org/10.1007/7653_2016_67

Lasting effects on body weight and mammary gland gene expression in female mice upon early life exposure to n-3 but not n-6 high-fat diets

Autor: Aldert H. Piersma, Aart Verhoef, Anja Westerman, Caleb A. Bastian, Amar V. Singh, Jeroen L. A. Pennings, Annemieke de Vries, Maia L. Green, Mirjam Luijten, M. Michele Pisano, Thomas B. Knudsen

Publikováno v: PLoS ONE, Vol 8, Iss 2, p e55603 (2013)
PLoS ONE

Exposure to an imbalance of nutrients prior to conception and during critical developmental periods can have lasting consequences on physiological processes resulting in chronic diseases later in life. Developmental programming has been shown to invo

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::4b9c5dfecab03b5649a0d2f888378d7d
http://europepmc.org/articles/PMC3567116?pdf=render

Response characteristics of the mitochondrial DNA genome in developmental health and disease

Autor: Thomas B. Knudsen, Maia L. Green

Publikováno v: Birth defects research. Part C, Embryo today : reviews. 72(4)

This review focuses on mitochondrial biology in mammalian development; specifically, the dynamics of information transfer from nucleus to mitochondrion in the regulation of mitochondrial DNA genomic expression, and the reverse signaling of mitochondr

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e86a84f0afb63bb52164d6566179cf44
https://pubmed.ncbi.nlm.nih.gov/15662705

Alternative Models of Developmental and Reproductive Toxicity in Pharmaceutical Risk Assessment and the 3Rs.

Autor: Brannen KC; Kimberly C. Brannen, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania. Robert E. Chapin, PhD, is a senior research fellow in the Developmental and Reproductive Toxicology Center of Expertise at Pfizer, Inc. in Groton, Connecticut. Abigail C. Jacobs, PhD, is an Associate Director of Pharmacology/Toxicology in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, Maryland. Maia L. Green, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania., Chapin RE; Kimberly C. Brannen, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania. Robert E. Chapin, PhD, is a senior research fellow in the Developmental and Reproductive Toxicology Center of Expertise at Pfizer, Inc. in Groton, Connecticut. Abigail C. Jacobs, PhD, is an Associate Director of Pharmacology/Toxicology in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, Maryland. Maia L. Green, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania., Jacobs AC; Kimberly C. Brannen, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania. Robert E. Chapin, PhD, is a senior research fellow in the Developmental and Reproductive Toxicology Center of Expertise at Pfizer, Inc. in Groton, Connecticut. Abigail C. Jacobs, PhD, is an Associate Director of Pharmacology/Toxicology in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, Maryland. Maia L. Green, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania., Green ML; Kimberly C. Brannen, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania. Robert E. Chapin, PhD, is a senior research fellow in the Developmental and Reproductive Toxicology Center of Expertise at Pfizer, Inc. in Groton, Connecticut. Abigail C. Jacobs, PhD, is an Associate Director of Pharmacology/Toxicology in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration in Silver Spring, Maryland. Maia L. Green, PhD, is a principal scientist in Safety Assessment and Laboratory Animal Resources at Merck & Co., Inc. in West Point, Pennsylvania.

Publikováno v: ILAR journal [ILAR J] 2016 Dec; Vol. 57 (2), pp. 144-156.