未登录 Fit for Purpose Assessment: A New Direction for IACUCs Kinter, Lewis B.; Johnson, David K.; Weichbrod, Robert H.; Prentice, Ernest D.; Simmonds, Richard C.; Houghton, Paul W.; Whitney, Robert A., Jr.; DeGeorge, Joseph; DeHaven, W. Ron; Kramer, Klaas; DeTolla, Louis 分享 收藏
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Analysis of exposure margins in developmental toxicity studies for detection of human teratogens Andrews, Paul A.; Blanset, Diann; Costa, Priscila Lemos; Green, Martin; Green, Maia L.; Jacobs, Abigail; Kadaha, Rajkumar; Lebron, Jose A.; Mattson, Britta; McNerney, Mary Ellen; Minck, Daniel; Oliveira, Luana de Castro; Theunissen, Peter T.; DeGeorge, Joseph J. 分享 收藏
An Industry Perspective on the 2017 EMA Guideline on First-in-Human and Early Clinical Trials DeGeorge, Joseph; Robertson, Sarah; Butler, Lynne; Derzi, Mazin; Stoch, S. Aubrey; Diaz, Dolores; Hartke, James; Guzzie-Peck, Peggy; Mortimer-Cassen, Elisabeth; Bogdanffy, Matthew; Will, Yvonne; Greene, Nigel 分享 收藏
Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective Butler, Lynne D.; Guzzie-Peck, Peggy; Hartke, James; Bogdanffy, Matthew S.; Will, Yvonne; Diaz, Dolores; Mortimer-Cassen, Elisabeth; Derzi, Mazin; Greene, Nigel; DeGeorge, Joseph J. 分享 收藏
Cardiac drug-drug interaction between HCV-NS5B pronucleotide inhibitors and amiodarone is determined by their specific diastereochemistry Lagrutta, Armando; Regan, Christopher P.; Zeng, Haoyu; Imredy, John P.; Koeplinger, Kenneth; Morissette, Pierre; Liu, Liping; Wollenberg, Gordon; Brynczka, Christopher; Lebron, Jose; DeGeorge, Joseph; Sannajust, Frederick 分享 收藏
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Interaction between amiodarone and hepatitis-C virus nucleotide inhibitors in human induced pluripotent stem cell-derived cardiomyocytes and HEK-293 Cav1.2 over-expressing cells Lagrutta, Armando; Zeng, Haoyu; Imredy, John; Balasubramanian, Bharathi; Dech, Spencer; Lis, Edward; Wang, Jixin; Zhai, Jin; DeGeorge, Joseph; Sannajust, Frederick 分享 收藏
Assessment of the clinical cardiac drug-drug interaction associated with the combination of hepatitis C virus nucleotide inhibitors and amiodarone in guinea pigs and rhesus monkeys Regan, Christopher P.; Morissette, Pierre; Regan, Hillary K.; Travis, Jeffery J.; Gerenser, Pamela; Wen, Jianzhong; Fitzgerald, Kevin; Gruver, Shaun; DeGeorge, Joseph J.; Sannajust, Frederick J. 分享 收藏
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Recommendations from a global cross-company data sharing initiative on the incorporation of recovery phase animals in safety assessment studies to support first-in-human clinical trials Sewell, Fiona; Chapman, Kathryn; Baldrick, Paul; Brewster, David; Broadmeadow, Alan; Brown, Paul; Burns-Naas, Leigh Ann; Clarke, Janet; Constan, Alex; Couch, Jessica; Czupalla, Oliver; Danks, Andy; DeGeorge, Joseph; de Haanm, Lolke; Hettinger, Klaudia; Hill, Marilyn; Festag, Matthias; Jacobs, Abby; Jacobson-Kram, David; Kopytek, Stephan; Lorenz, Helga; Moesgaard, Sophia Gry; Moore, Emma; Pasanen, Markku; Perry, Rick; Ragan, Ian; Robinson, Sally; Schmitt, Petra M.; Short, Brian; Lima, Beatriz Silva; Smith, Diane; Sparrow, Sue; van Bekkum, Yvette; Jones, David 分享 收藏
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A rationale for determining, testing, and controlling specific impurities in pharmaceuticals that possess potential for genotoxicity Müller, L; Mauthe, RJ; Riley, CM; Andino, MM; De Antonis, D; Beels, C; DeGeorge, J; De Knaep, AGM; Ellison, D; Fagerland, JA; Frank, R; Fritschel, B; Galloway, S; Harpur, E; Humfrey, CDN; Jacks, AS; Jagota, N; Mackinnon, J; Mohan, G; Ness, DK; O'Donovan, MR; Smith, MD; Vudathala, G; Yotti, L 分享 收藏
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Considerations for toxicology studies of respiratory drug products DeGeorge, JJ; Ahn, CH; Andrews, PA; Brower, ME; Choi, YS; Chun, MY; Du, T; Doo, YLH; McGuinn, WD; Pei, LQ; Sancilio, LF; Schmidt, W; Sheevers, HV; Sun, CJ; Tripathi, S; Vogel, WM; Whitehurst, V; Williams, S; Taylor, AS 分享 收藏
Response to Monro and Mehta proposal for use of single-dose toxicology studies to support single-dose studies of new drugs in humans Choudary, J; Contrera, JF; DeFelice, A; DeGeorge, JJ; Farrelly, JG; Fitzgerald, G; Goheer, MA; Jacobs, A; Jordan, A; Meyers, L; Osterberg, R; Resnick, C; Sun, CJ; Temple, RJ 分享 收藏
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