Zobrazeno 1 - 10
of 25
pro vyhledávání: '"Martin D. Green"'
Autor:
Patricia E. Ganey, Kenneth L. Hastings, Martin D. Green, Robert A. Roth, Bin Gao, Gary R. Burleson
Publikováno v:
Int J Toxicol
The liver is primarily thought of as a metabolic organ; however, the liver is also an important mediator of immunological functions. Key perspectives on this emerging topic were presented in a symposium at the 2018 annual meeting of the American Coll
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e2c820d4a2d7119343bf6bfb2a9271d6
https://doi.org/10.1177/1091581819898399
https://doi.org/10.1177/1091581819898399
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
https://pubmed.ncbi.nlm.nih.gov/30981719
Autor:
Raymond D. Harbison, Jennifer M White, Claudia Wrzesinski, Martin D. Green, Alison Abritis, Giffe T. Johnson, James McCluskey
Publikováno v:
Toxicology mechanisms and methods. 26(4)
Safety assessment evaluating the presence of impurities, residual materials, and contaminants in vaccines is a focus of current research. Thresholds of toxicological concern (TTCs) are mathematically modeled levels used for assessing the safety of ma
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::2b8c590baf6d98682a473075f06febfd
https://pubmed.ncbi.nlm.nih.gov/27098016
https://pubmed.ncbi.nlm.nih.gov/27098016
Autor:
Iftekhar Mahmood, Martin D. Green
Publikováno v:
The Journal of Clinical Pharmacology. 47:1540-1554
Drug interactions can alter the pharmacokinetics and/or pharmacodynamics of a drug. In pharmacokinetic drug interactions, the concentrations of 1 or more drugs are altered by another. This change in concentration in a given drug may be due to changes
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c03c57e73d972052412787332f5b4ebb
https://doi.org/10.1177/0091270007308616
https://doi.org/10.1177/0091270007308616
Autor:
Martin D. Green
Publikováno v:
International journal of toxicology. 34(5)
The objective of this study was to determine the effects of investigational vaccine candidates on acute-phase proteins (APPs) as determined in GLP toxicology studies. Sixty-four GLP toxicity studies, which were submitted to the Food and Drug Administ
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::74ef49ff9aa55b1e61c43044115ceae5
https://pubmed.ncbi.nlm.nih.gov/26268767
https://pubmed.ncbi.nlm.nih.gov/26268767
Autor:
Martin D Green, Iftekhar Mahmood
Publikováno v:
Clinical Pharmacokinetics. 44:331-347
With an increasing number of therapeutic proteins moving into preclinical and clinical development, pharmacokinetic factors play an important role in the development of these macromolecules. It is also important that the pharmacokinetic evaluation of
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::f6175903d61fec29f6d67a45472e7584
https://doi.org/10.2165/00003088-200544040-00001
https://doi.org/10.2165/00003088-200544040-00001
Publikováno v:
The Journal of Clinical Pharmacology. 43:692-697
The authors describe four approaches to selecting a safe starting dose for humans in clinical drug trials based on interspecies scaling of clearance. Human clearance was predicted by scaling for 10 example drugs for which animal clearance values were
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eccf28cadc1cb1bd184900bc06be10bd
https://doi.org/10.1177/0091270003254631
https://doi.org/10.1177/0091270003254631
Autor:
Martin D. Green, Lorin Roskos, Carl C. Peck, Lawrence J. Lesko, Gerald R. Galluppi, Mark Rogge, David W. Feigal
Publikováno v:
Clinical Pharmacology & Therapeutics. 69:387-399
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::84dbfc81de9235a397f010ce2ac6928b
https://doi.org/10.1067/mcp.2001.115455
https://doi.org/10.1067/mcp.2001.115455
Autor:
Martin D. Green
Publikováno v:
International Journal of Toxicology. 16:33-40
The absence of activity may represent either a true or false negative effect. If an assay is valid for the particular test article and fails to indicate activity, it is an appropriate indicator of future events. However, if the assay is insensitive o
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::0e9e59501f8d823385866ee7cec7988d
https://doi.org/10.1080/109158197227341
https://doi.org/10.1080/109158197227341
Publikováno v:
Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::bb7d7fcd2091156c558d99737e84b0bd
https://doi.org/10.1002/9781118517000.ch18
https://doi.org/10.1002/9781118517000.ch18
