Search Results - "Degeorge, Joseph J"

An Evaluation of the Impact of PD-1 Pathway Blockade on Reproductive Safety of Therapeutic PD-1 Inhibitors by Poulet, Frederique M., Wolf, Jayanthi J., Herzyk, Danuta J., DeGeorge, Joseph J.

“…This report discusses the principles of reproductive toxicity risk assessment for biopharmaceuticals blocking the PD‐1/programmed cell death ligand 1 (PD‐L1)…”
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Analysis of exposure margins in developmental toxicity studies for detection of human teratogens by Andrews, Paul A., Blanset, Diann, Costa, Priscila Lemos, Green, Martin, Green, Maia L., Jacobs, Abigail, Kadaba, Rajkumar, Lebron, Jose A., Mattson, Britta, McNerney, Mary Ellen, Minck, Daniel, Oliveira, Luana de Castro, Theunissen, Peter T., DeGeorge, Joseph J.

“…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…”
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An Industry Perspective on the Utility of Short-Term Carcinogenicity Testing in Transgenic Mice in Pharmaceutical Development by Storer, Richard D., Sistare, Frank D., Vijayaraj Reddy, M., Degeorge, Joseph J.

“…International guidelines allow for use of a short-term cancer bioassay (twenty-six weeks) in transgenic mice as a substitute for one of the two required…”
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A Brief History of Use of Animals in Biomedical Research and Perspective on Non-Animal Alternatives by Kinter, Lewis B, DeHaven, Ron, Johnson, David K, DeGeorge, Joseph J

“…Abstract Animals have been closely observed by humans for at least 17 000 years to gain critical knowledge for human and later animal survival. Routine…”
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Exposure assessments in reproductive and developmental toxicity testing: An IQ-DruSafe industry survey on current practices and experiences in support of exposure-based high dose selection by Andrews, Paul A., McNerney, Mary Ellen, DeGeorge, Joseph J.

“…The draft ICH S5(R3) guideline includes an exposure-based endpoint as an option for selecting the high dose in developmental and reproductive toxicity (DART)…”
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Current nonclinical testing paradigms in support of safe clinical trials: An IQ Consortium DruSafe perspective by 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.

“…The transition from nonclinical to First-in-Human (FIH) testing is one of the most challenging steps in drug development. In response to serious outcomes in a…”
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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 by 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.

“…In 2015, European and U.S. health agencies issued warning letters in response to 9 reported clinical cases of severe bradycardia/bradyarrhythmia in hepatitis C…”
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Scientific Knowledge and Technology, Animal Experimentation, and Pharmaceutical Development by Kinter, Lewis B, DeGeorge, Joseph J

“…Human discovery of pharmacologically active substances is arguably the oldest of the biomedical sciences with origins >3500 years ago. Since ancient times,…”
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An Analysis of Pharmaceutical Experience with Decades of Rat Carcinogenicity Testing: Support for a Proposal to Modify Current Regulatory Guidelines by Sistare, Frank D., Morton, Daniel, Alden, Carl, Christensen, Joel, Keller, Douglas, Jonghe, Sandra De, Storer, Richard D., Reddy, M. Vijayaraj, Kraynak, Andrew, Trela, Bruce, Bienvenu, Jean-Guy, Bjurström, Sivert, Bosmans, Vanessa, Brewster, David, Colman, Karyn, Dominick, Mark, Evans, John, Hailey, James R., Kinter, Lewis, Liu, Matt, Mahrt, Charles, Marien, Dirk, Myer, James, Perry, Richard, Potenta, Daniel, Roth, Arthur, Sherratt, Philip, Singer, Thomas, Slim, Rabih, Soper, Keith, Fransson-Steen, Ronny, Stoltz, James, Turner, Oliver, Turnquist, Susan, van Heerden, Marjolein, Woicke, Jochen, DeGeorge, Joseph J.

“…Data collected from 182 marketed and nonmarketed pharmaceuticals demonstrate that there is little value gained in conducting a rat two-year carcinogenicity…”
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Regulatory Forum Commentary Counterpoint: Dose Selection for Tg.rasH2 Mouse Carcinogenicity Studies by Darbes, Jarig, Sistare, Frank D., DeGeorge, Joseph J.

“…High-dose selection for 6-month carcinogenicity studies of pharmaceutical candidates in Tg.rasH2-transgenic mice currently primarily relies on (1) estimation…”
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Toxicogenomics in drug development: a match made in heaven? by Qin, Chunhua, Tanis, Keith Q, Podtelezhnikov, Alexei A, Glaab, Warren E, Sistare, Frank D, DeGeorge, Joseph J

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Role of chronic toxicology studies in revealing new toxicities by Galijatovic-Idrizbegovic, Alema, Miller, Judith E., Cornell, Wendy D., Butler, James A., Wollenberg, Gordon K., Sistare, Frank D., DeGeorge, Joseph J.

“…Chronic (>3 months) preclinical toxicology studies are conducted to support the safe conduct of clinical trials exceeding 3 months in duration. We have…”
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Carcinogenicity Testing and the Evaluation of Regulatory Requirements for Pharmaceuticals by Contrera, Joseph F, Jacobs, Abigail C, DeGeorge, Joseph J

“…The results of rat and mouse carcinogenicity studies for 282 human pharmaceuticals in the FDA database were analyzed and compared as part of an International…”
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Characterization of an investigative safety pharmacology model to assess comprehensive cardiac function and structure in chronically instrumented conscious beagle dogs by Regan, Christopher P., Stump, Gary L., Detwiler, Theodore J., Chen, Li, Regan, Hillary K., Gilberto, David B., DeGeorge, Joseph J., Sannajust, Frederick J.

“…There has been an increasing need to conduct investigative safety pharmacology studies to complement regulatory-required studies, particularly as it applies to…”
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Safety Assessment of Drug Metabolites: Implications of Regulatory Guidance and Potential Application of Genetically Engineered Mouse Models that Express Human P450s by Powley, Mark W, Frederick, Clay B, Sistare, Frank D, DeGeorge, Joseph J

“…Species differences in drug metabolism present two challenges that may confound the nonclinical safety assessment of candidate drugs. The first challenge is…”
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Promise of new translational safety biomarkers in drug development and challenges to regulatory qualification by Sistare, Frank D, DeGeorge, Joseph J

“…One promise of new translational safety biomarkers (TSBs) is their ability to demonstrate that toxicities in animal studies are monitorable at an early stage,…”
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Applications of toxicogenomics to nonclinical drug development: regulatory science considerations by Sistare, Frank D, Degeorge, Joseph J

“…Scientists in the pharmaceutical industry have ready access to samples from animal toxicology studies carefully designed to test the safety characteristics of…”
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Predictive Value of Preclinical Toxicology Studies for Platinum Anticancer Drugs by CLARK, D. L, ANDREWS, P. A, SMITH, D. D, DEGEORGE, J. J, JUSTICE, R. L, BEITZ, J. G

“…Rodent and nonrodent toxicology studies are currently expected to support Phase I trials of antineoplastic drugs in the United States. To determine the…”
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Considerations for Toxicology Studies of Respiratory Drug Products by Degeorge, Joseph J, Ahn, Chang Ho, Andrews, Paul A, Brower, Margaret E, Choi, Young S, Chun, Misoon Y, Du, Tao, Lee-Ham, Doo Young, McGuinn, W.David, Pei, Luqi, Sancilio, Lawrence F, Schmidt, Wendelyn, Sheevers, Hilary V, Sun, C.Joseph, Tripathi, Satish, Vogel, W.Mark, Whitehurst, Virgil, Williams, Shannon, Taylor, Alan S

“…The standard approaches for the preclinical development of chronically administered drugs also apply to most respiratory drugs. Modifications from the standard…”
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Food and Drug Administration viewpoints on toxicokinetics: the view from review by DeGeorge, J J

“…The importance of drug kinetics for interpretation of toxicity findings and for cross-species toxicity assessment has been long recognized. Recently, an…”
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