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1. Design of Studies and Risk Management in Toxicologic Pathology

Author

Ricardo Ochoa

Subjects
Engineering, Pathology, medicine.medical_specialty, business.industry, medicine, Risk communication, Product (category theory), business, Risk assessment, Risk management
Abstract

This chapter discusses the issues of risk assessment, management, communication, and abatement that are important to the Toxicologic Pathologist to understand the significance of their contribution as it relates to the health of humans and the environment following exposure to products in development for use as pharmaceutical of chemical compounds. The division of the development stages is discussed along with the most important practices to make the contributions of the Toxicologic Pathologist useful to the client, ethically rigorous, and responsive to the needs of the public.

Published
2018
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2. Contributors

Author

E. Terence Adams, Rick Adler, Carl L. Alden, Phillip M. Bartholomew, Joydeep Basu, Val R. Beasley, Brian R. Berridge, Timothy A. Bertram, Hyo-eun Bhang, Hugh E. Black, Brad Bolon, Gary A. Boorman, Denise I. Bounous, Rogely Waite Boyce, William M. Bracken, Amy E. Brix, Danielle Brown, Mark T. Butt, Glenn H. Cantor, Bruce D. Car, Vincent Castranova, Russell C. Cattley, Curtis Chan, Robert E. Chapin, Samuel M. Cohen, Steve Colegate, Daniel Cook, Paul S. Cooke, Torrie A. Crabbs, Dianne M. Creasy, James W. Crissman, John M. Cullen, Dimitry M. Danilenko, Barbara Davis, Myrtle A. Davis, T. Zane Davis, Ronald A. DeLellis, Nancy D. Denslow, Kelly L. Diegel, David C. Dorman, Richard R. Dubielzig, Stephen K. Durham, Sandy Eldridge, Susan A. Elmore, Jeffrey I. Everitt, Suzanne Fenton, Duncan C. Ferguson, Reuel Field, George L. Foley, William R. Foster, Jerry D. Frantz, Kathy Gabrielson, Shayne C. Gad, Elizabeth J. Galbreath, Dale R. Gardner, Robert H. Garman, Santokh Gill, Peter Glerup, Dale L. Goad, Mary Elizabeth Pecquet Goad, Nanna Grand, Benjamin T. Green, Kathryn E. Gropp, Hans Jørgen G. Gundersen, Diane Gunson, Ramesh C. Gupta, Sharon M. Gwaltney-Brant, Jeffery O. Hall, Wendy Halpern, Gordon C. Hard, Jerry F. Hardisty, Jack R. Harkema, Philip W. Harvey, Wanda M. Haschek, Kathleen Heinz-Taheny, Ronald A. Herbert, Eugene Herman, Mark Hoenerhoff, Ann Hubbs, David Hutto, Evan B. Janovitz, Kanwar Nasir M. Khan, Kevin P. Keenan, Roy L. Kerlin, John M. Kreeger, Kannan Krishnan, C. Frieke Kuper, Stephen T. Lee, Lois D. Lehman-McKeeman, Xiantang Li, Eric D. Lombardini, Calvert Louden, John W. Ludlow, David E. Malarkey, Peter C. Mann, Robert R. Maronpot, Kevin S. McDorman, Mark A. Melanson, Robert Mercer, Rosanna Mirabile, Ronald W. Moch, James P. Morrison, Daniel Morton, Laura Dill Morton, Sureshkumar Muthupalani, Kristen J. Nikula, Ricardo Ochoa, Michelle E. Pacheco-Thompson, Olga M. Pulido, Kip E. Panter, George A. Parker, Dale W. Porter, Douglas Reid Patterson, James A. Pfister, Carl A. Pinkert, Lila Ramaiah, Deepa B. Rao, Donald G. Robertson, Jennifer Rojko, Thomas J. Rosol, Colin G. Rousseaux, Daniel G. Rudmann, Christine Ruehl-Fehlert, Linda Sargent, Christina M. Satterwhite, Kenneth A. Schafer, Philip F. Solter, Robert C. Sills, Liz Simon, Mikala Skydsgaard, Graham S. Smith, Krishnan Sriram, Bryan L. Stegelmeier, John M. Sullivan, Catherine Sutcliffe, James A. Swenberg, Polina Sysa-Shah, Leandro Teixeira, Noriko Tsuchiya, John L. Vahle, John F. Van Vleet, Aurore Varela, Kenneth A. Voss, Robin M. Walker, Matthew A. Wallig, Gail L. Walter, Kevin D. Welch, Paul White, Christopher T. Winkelmann, Zbigniew W. Wojcinski, and Jeffrey C. Wolf

Published
2013
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3. Haschek and Rousseaux's Handbook of Toxicologic Pathology

Author

Colin G. Rousseaux, Wanda M. Haschek, Beth W. Mahler, Brad Bolon, Matthew A. Wallig, and Ricardo Ochoa

Subjects
Pathology, medicine.medical_specialty, business.industry, medicine, Full color, business
Abstract

Haschek and Rousseaux's Handbook of Toxicologic Pathology is a key reference on the integration of structure and functional changes in tissues associated with the response to pharmaceuticals, chemicals and biologics. The 3e has been expanded by a full volume, and covers aspects of safety assessment not discussed in the 2e. Completely revised with many new chapters, it remains the most authoritative reference on toxicologic pathology for scientists and researchers studying and making decisions on drugs, biologics, medical devices and other chemicals, including agrochemicals and environmental contaminants. New topics include safety assessment, the drug life cycle, risk assessment, communication and management, carcinogenicity assessment, pharmacology and pharmacokinetics, biomarkers in toxicologic pathology, quality assurance, peer review, agrochemicals, nanotechnology, food and toxicologic pathology, the environment and toxicologic pathology and more. It provides new chapters and in-depth discussion of timely topics in the area of toxicologic pathology and broadens the scope of the audience to include toxicologists and pathologists working in a variety of settings. It offers high-quality and trusted content in a multi-contributed work written by leading international authorities in all areas of toxicologic pathology. It features hundreds of full color images in both the print and electronic versions of the book to highlight difficult concepts with clear illustrations.

Published
2013
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4. Pathology Issues in the Design of Toxicology Studies

Author

Ricardo Ochoa

Subjects
Toxicology studies, Pathology, medicine.medical_specialty, surgical procedures, operative, business.industry, Medicine, business
Abstract

This chapter discusses multiple issues that the toxicologic pathologist should take into consideration when evaluating data from toxicologic studies: what the toxicology studies are intended for, and what issues must be taken into consideration, from the standpoint of the pathologist, in order to avoid bias and assure the accuracy of the pathology data. The chapter includes discussions on the issues of nomenclature, historical data, adverse effects, severity grades, diagnostic approaches to clarify effects, and multiple other pieces of information important to the toxicologist and toxicologic pathologist in designing studies.

Published
2013
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5. Risk Management in Non-Clinical Drug Development

Author

Ricardo Ochoa and Robert C. Sills

Subjects
Engineering, Drug development, Risk analysis (engineering), business.industry, Non clinical, Management science, Financial risk, business, Business risks, Risk management, Pharmaceutical industry
Abstract

The risk management process as it refers to non-clinical safety issues is a discipline that applies to all significant issues arising from toxicologic studies. Addressing the issues encountered in development of compounds is essential to the continuation of their development. This chapter presents the concept of safety vs financial risks for drug and chemical developers. The development of scientifically reliable and documentable information surrounding the observed adverse effect is critical to finding a path forward for the compound in question. This chapter presents a multiplicity of situations where adverse effects can be encountered, and strategies that can be followed to address those issues, illustrating them with actual examples from the pharmaceutical industry.

Published
2013
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6. LIST OF CONTRIBUTORS

Author

Carl L. Alden, Brian R. Berridge, Brad Bolon, Denise I. Bounous, Mark T. Butt, Russell C. Cattley, Robert E. Chapin, Sandrine F. Chebekoue, Dianne M. Creasy, John M. Cullen, Dimitry M. Danilenko, Barbara Davis, Kelly L. Diegel, David C. Dorman, Richard R. Dubielzig, Susan A. Elmore, Suzanne E. Fenton, Duncan C. Ferguson, George L. Foley, Robert H. Garman, Kathryn E. Gropp, Diane Gunson, Gordon C. Hard, Jack R. Harkema, Wanda M. Haschek, Eugene Herman, Mark J. Hoenerhoff, Evan B. Janovitz, Kanwar N.M. Khan, Kannan Krishnan, C. Frieke Kuper, Lois D. Lehman-McKeeman, Xiantang Li, David E. Malarkey, Robert R. Maronpot, Kristen J. Nikula, Ricardo Ochoa, George A. Parker, Lila Ramaiah, Colin G. Rousseaux, Daniel G. Rudmann, Christine Ruehl-Fehlert, Stefan U. Ruepp, Kenneth A. Schafer, John M. Sullivan, Leandro Teixeira, John F. Van Vleet, Aurore Varela, Matthew A. Wallig, and Zbigniew W. Wojcinski

Published
2008
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