Eskes, Chantra
Validation of Alternative Methods for Toxicity Testing
1. Introduction
Chantra Eskes, Maurice Whelan
2. Validation in Support of Internationally Harmonised OECD Test Guidelines for Assessing the Safety of Chemicals
Anne Gourmelon, Nathalie Delrue
3. Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals
Sonja Beken, Peter Kasper, Jan-Willem Laan
4. Validation of Alternative In Vitro Methods to Animal Testing: Concepts, Challenges, Processes and Tools
Claudius Griesinger, Bertrand Desprez, Sandra Coecke, Warren Casey, Valérie Zuang
5. Practical Aspects of Designing and Conducting Validation Studies Involving Multi-study Trials
Sandra Coecke, Camilla Bernasconi, Gerard Bowe, Ann-Charlotte Bostroem, Julien Burton, Thomas Cole, Salvador Fortaner, Varvara Gouliarmou, Andrew Gray, Claudius Griesinger, Susanna Louhimies, Emilio Mendoza-de Gyves, Elisabeth Joossens, Maurits-Jan Prinz, Anne Milcamps, Nicholaos Parissis, Iwona Wilk-Zasadna, João Barroso, Bertrand Desprez, Ingrid Langezaal, Roman Liska, Siegfried Morath, Vittorio Reina, Chiara Zorzoli, Valérie Zuang
6. Validation of Computational Methods
Grace Patlewicz, Andrew P. Worth, Nicholas Ball
7. Implementation of New Test Methods into Practical Testing
Rodger D. Curren, Albrecht Poth, Hans A. Raabe
8. Pathway Based Toxicology and Fit-for-Purpose Assays
Rebecca A. Clewell, Patrick D. McMullen, Yeyejide Adeleye, Paul L. Carmichael, Melvin E. Andersen
9. Evidence-Based Toxicology
Sebastian Hoffmann, Thomas Hartung, Martin Stephens
10. Validation of Transcriptomics-Based
Raffaella Corvi, Mireia Vilardell, Jiri Aubrecht, Aldert Piersma
11. Ensuring the Quality of Stem Cell-Derived
Glyn N. Stacey, Sandra Coecke, Anna-Bal Price, Lyn Healy, Paul Jennings, Anja Wilmes, Christian Pinset, Magnus Ingelman-Sundberg, Jochem Louisse, Simone Haupt, Darren Kidd, Andrea Robitski, Heinz-Georg Jahnke, Gilles Lemaitre, Glenn Myatt
12. Validation of Bioreactor and Human-on-a-Chip Devices for Chemical Safety Assessment
Sofia P. Rebelo, Eva-Maria Dehne, Catarina Brito, Reyk Horland, Paula M. Alves, Uwe Marx
13. Integrated Approaches to Testing and Assessment
Andrew P. Worth, Grace Patlewicz
14. International Harmonization and Cooperation in the Validation of Alternative Methods
João Barroso, Il Young Ahn, Cristiane Caldeira, Paul L. Carmichael, Warren Casey, Sandra Coecke, Rodger Curren, Bertrand Desprez, Chantra Eskes, Claudius Griesinger, Jiabin Guo, Erin Hill, Annett Janusch Roi, Hajime Kojima, Jin Li, Chae Hyung Lim, Wlamir Moura, Akiyoshi Nishikawa, HyeKyung Park, Shuangqing Peng, Octavio Presgrave, Tim Singer, Soo Jung Sohn, Carl Westmoreland, Maurice Whelan, Xingfen Yang, Ying Yang, Valérie Zuang
15. Evolving the Principles and Practice of Validation for New Alternative Approaches to Toxicity Testing
Maurice Whelan, Chantra Eskes
Keywords: Biomedicine, Pharmaceutical Sciences/Technology, Molecular Medicine
- Editor
- Eskes, Chantra
- Whelan, Maurice
- Publisher
- Springer
- Publication year
- 2016
- Language
- en
- Edition
- 1
- Series
- Advances in Experimental Medicine and Biology
- Page amount
- 20 pages
- Category
- Medicine, Health Care, Mode
- Format
- Ebook
- eISBN (PDF)
- 9783319338262
- Printed ISBN
- 978-3-319-33824-8