A review of the abuse potential assessment of atomoxetine: a nonstimulant medication for attention-deficit/hyperactivity disorder
Upadhyaya, Himanshu P., Desaiah, Durisala, Schuh, Kory J., Bymaster, Frank P., Kallman, Mary J., Clarke, David O., Durell, Todd M., Trzepacz, Paula T., Calligaro, David O., Nisenbaum, Eric S., Emmerson, Paul J., Schuh, Leslie M., Bickel, Warren K., Allen, Albert J.
Published in Psychopharmacology (01.03.2013)
Published in Psychopharmacology (01.03.2013)
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Journal Article
Exploring Greater Flexibility for Chronic Toxicity Study Designs to Support Human Safety Assessment While Balancing 3Rs Considerations
Prior, Helen, Baldrick, Paul, Clarke, David O., Passini, Elisa, Sewell, Fiona, van Meer, Peter
Published in International Journal of Toxicology (31.05.2024)
Published in International Journal of Toxicology (31.05.2024)
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Book Review
Journal Article
Exploring the Definition of “Similar Toxicities”: Case Studies Illustrating Industry and Regulatory Interpretation of ICH S6(R1) for Long-Term Toxicity Studies in One or Two Species
Prior, Helen, Clarke, David O, Jones, David, Salicru, Eleni, Schutten, Melissa M, Sewell, Fiona
Published in International Journal of Toxicology (01.05.2022)
Published in International Journal of Toxicology (01.05.2022)
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Book Review
Journal Article
Strategies and Recommendations for Using a Data-Driven and Risk-Based Approach in the Selection of First-in-Human Starting Dose: An International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) Assessment
Leach, Michael W, Clarke, David O, Dudal, Sherri, Han, Chao, Li, Chunze, Yang, Zheng, Brennan, Frank R, Bailey, Wendy J, Chen, Yingxue, Deslandes, Antoine, Loberg, Lise I, Mayawala, Kapil, Rogge, Mark C, Todd, Marque, Chemuturi, Nagendra V
Published in Clinical pharmacology and therapeutics (01.06.2021)
Published in Clinical pharmacology and therapeutics (01.06.2021)
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Journal Article
Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach
Chien, Hsiao-Tzu, Prior, Helen, Andrews, Laura, van Aerts, Leon, Cauvin, Annick, Clarke, David O., Datta, Kaushik, Dempster, Maggie, Dybdal, Noel, Freebern, Wendy, de Haan, Lolke, Herzyk, Danuta, Hey, Adam, Kissner, Thomas, Kronenberg, Sven, Leach, Michael W., Lee, Donna, Schutte, Katrin, Sewell, Fiona, Trouba, Kevin, Ulrich, Peter, Weir, Lucinda, van Meer, Peter
Published in Regulatory toxicology and pharmacology (01.02.2023)
Published in Regulatory toxicology and pharmacology (01.02.2023)
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Journal Article
The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain
Prior, Helen, Andrews, Laura, Cauvin, Annick, Chien, Hsiaotzu, Clarke, David O., Datta, Kaushik, Dempster, Maggie, Dybdal, Noel, Freebern, Wendy, de Haan, Lolke, Herzyk, Danuta, Hey, Adam, Kissner, Thomas, Kronenberg, Sven, Leach, Michael W., Lee, Donna, Reid, Kirsty, Schutte, Katrin, Sewell, Fiona, Trouba, Kevin, Ulrich, Peter, van Aerts, Leon, van Meer, Peter, Weir, Lucinda
Published in Regulatory toxicology and pharmacology (01.02.2023)
Published in Regulatory toxicology and pharmacology (01.02.2023)
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Journal Article
The Use of Minipigs for Preclinical Safety Assessment by the Pharmaceutical Industry: Results of an IQ DruSafe Minipig Survey
Colleton, Curtis, Brewster, David, Chester, Anne, Clarke, David O, Heining, Peter, Olaharski, Andrew, Graziano, Michael
Published in Toxicologic pathology (01.04.2016)
Published in Toxicologic pathology (01.04.2016)
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Journal Article
An assessment of the central disposition of intranasally administered insulin lispro in the cerebrospinal fluid of healthy volunteers and beagle dogs
Lowe, Stephen, Sher, Emanuele, Wishart, Graham, Jackson, Kimberley, Yuen, Eunice, Brittain, Claire, Fong, Siew Chinn, Clarke, David O., Landschulz, William H.
Published in Drug delivery and translational research (01.02.2017)
Published in Drug delivery and translational research (01.02.2017)
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Journal Article
A critical review of the toxicology of glutaraldehyde
Beauchamp, Jr, R O, St Clair, M B, Fennell, T R, Clarke, D O, Morgan, K T, Kari, F W
Published in Critical reviews in toxicology (1992)
Published in Critical reviews in toxicology (1992)
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Journal Article
Characterization of urinary metabolites from [1,2,methoxy-13C]-2-methoxyethanol in mice using carbon-13 nuclear magnetic resonance spectroscopy
Sumner, Susan C. J, Stedman, Donald B, Clarke, David O, Welsch, Frank, Fennell, Timothy R
Published in Chemical research in toxicology (01.07.1992)
Published in Chemical research in toxicology (01.07.1992)
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Journal Article
The Selective Estrogen Receptor Modulator, Raloxifene: Reproductive Assessments Following Preimplantation Exposure in Mated Female Rats
Clarke, David O, Griffey, Kelly I, Buelke-Sam, Judy, Francis, Paul C
Published in Reproductive toxicology (Elmsford, N.Y.) (01.05.1998)
Published in Reproductive toxicology (Elmsford, N.Y.) (01.05.1998)
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Journal Article
2-Methoxyethanol metabolism in pregnant CD-1 mice and embryos
Mebus, C A, Clarke, D O, Stedman, D B, Welsch, F
Published in Toxicology and applied pharmacology (01.01.1992)
Published in Toxicology and applied pharmacology (01.01.1992)
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Journal Article
The Selective Estrogen Receptor Modulator, Raloxifene: Reproductive Assessments Following Preimplantation Exposure in Mated Female Rats 11These studies were conducted in accordance with the Food and Drug Administration “Good Laboratory Practice Regulations for Nonclinical Laboratory Studies.” CRF Part 58, 1978
Clarke, David O, Griffey, Kelly I, Buelke-Sam, Judy, Francis, Paul C
Published in Reproductive toxicology (Elmsford, N.Y.) (01.05.1998)
Published in Reproductive toxicology (Elmsford, N.Y.) (01.05.1998)
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Journal Article