Preclinical safety evaluation of biopharmaceuticals: a science-based approach to facilitating clinical trials

Proper preclinical safety evaluation can lessen the time and cost of launching new biopharmaceuticals and speed potentially life-saving drugs to market. This guide covers everything from lead candidate selection to establishing proofof concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical SafetyEvaluation of Biopharmaceuticals: A Science-Based Approach to Facilitating Clinical Trials: Includes an overview of biopharmaceuticals with information on regulation and methods of production Discusses the principles of ICH S6 and their implementation in the U.S., Europe, and Japan Covers current practices in preclinical development and includes a comparison of safety assessments for small molecules with those for biopharmaceuticals Addresses all aspects of the preclinical evaluation process, including: the selection of relevant species; safety/toxicity endpoints; specific considerations based upon class; and practical considerations in the design, implementation, and analysis of biopharmaceuticals Covers transitioning from preclinical development to clinical trials This is a hands-on, straightforward reference for professionals involved in preclinical drug development, including scientists, toxicologists, project managers, consultants, and regulatory personnel. INDICE: Forward (Joy Cavagnaro and Anthony D. Dayan). PART I. BACKGROUND. Chapter 1. Biopharmaceuticals: Definition and Regulation (Lincoln Tsang and Nathan Cortez). Chapter 2. Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact (Patricia Williams). PART II. PRINCIPLESOF PRECLINICAL DEVELOPMENT. Chapter 3. The Principles of ICH S6 and the Case-by-Case Approach (Joy Cavagnaro). Chapter 4. Implementation of ICH S6: European Perspective (Peter Ryle, and David Snodin). Chapter 5. Implementation of ICHS6: Japanese Perspective (Takahiru Nakazawa). Chapter 6. Implementation of ICH S6: US Perspective (Mary Ellen Cosenza). PART III. CURRENT PRACTICES IN PRECLINICAL DEVELOPMENT . Chapter 7. Comparison of Small Molecule vs. Large Molecule Development (early stage) (Christopher Horvath). Chapter 8. Comparability Assessment During Biopharmaceutical Clinical Development (Richard Lewis). PART IV. SELECTION OF RELEVANT SPECIES. Chapter 9. In Vitro/In Vivo Testing to Support Relevant Species Selection (Meena Subramanyam, Nicola Rinaldi, Elisabeth Mertsching, and David Hutto). Chapter 10. Design and Analysis of Tissue Cross Reactivity Studies (William Hall, Shari A. Price-Schiavi, Joan Wicks, and Jennifer L. Rojko). Chapter 11. Physiological IgG Biodistribution, Transport and Clearance: Implications for Monoclonal Antibody Products (Jennifer L. Rojko, andShari Price-Schiavi). Chapter 12. The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species (M. David Green, and Melanie Hartsough). Chapter 13. Use of Animal Models of Disease in the Preclinical Safety Evaluation of Biopharmaceuticals (Johan te Koppele, and Renger Witkamp). PART V. SAFETY/TOXICITY ENDPOINTS. Chapter 14. Safety Pharmacology: Similarities and Differences Between Small Molecules and Novel Biopharmaceuticals (Edward W. Bernton). Chapter 15. Genetic Toxicity Testing of Biopharmaceuticals (David Jacobson-Kram, and Hanan Ghantous). Chapter 16. General Toxicity and Immunotoxicity Testing of Biopharmaceuticals (Jeanine L. Bussiere). Chapter 17 Reproductive Toxicity Assessment of Biopharmaceuticals (Pauline Martin). Chapter 18. Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Non human Primates (Gerhard F. Weinbauer, Werner Frings, Antje Fuchs, Michel Niehaus, and Ingrid Osterburg). Chapter 19. Assessment of Carcinogenic Risk of Biopharmaceuticals (Joy A. Cavagnaro). Chapter 20. Immunogenicity (Huub Schellekens, Wim Jiskoot, and Miranda van Beers). Chapter 21. Assessment of Autoimmunity and Hypersensitivity (Jacques Descotes, and Thierry Vial). PART VI. SPECIFIC CONSIDERATIONS BASED UPON PRODUCT CLASS. Chapter 22. Preclinical Toxicity Development of Peptides (Shawn Heidel, and Todd Page). Chapter 23. Preclinical Safety Evaluation of Replacement Enzymes (Laura Andrews). Chapter 24. The Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities (Arthur A. Levin, and Scott P. Henry). Chapter 25. Preclinical Safety Evaluation of Biological Oncology Drugs (Theresa Reynolds). Chapter 26. Preclinical Safety Evaluation of Monoclonal Antibodies (George Treacy, and Pauline Martin). Chapter 27. Immunomodulatory Biopharmaceuticals and Risk of Neoplasia (Peter J. Bugelski, Clifford Sachs, Joel Cornacoff, Pauline Martin, and George Treacy). Chapter 28. Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold Therapeutics (Stanley A. Roberts, Gary Woodnutt, and Curt W. Bradshaw). Chapter 29. Preclinical Safety Evaluation of Immunotoxins (Jennifer Brown, Joycelyn Entwistle, Nick Glover, and Glen C. MacDonald). Chapter 30. Preclinical Safety Evaluation Blood Products (Richard M. Lewis). Chapter 31. Preclinical Safety Evaluation of Viral Vaccines (Maggie Dempster, and Richard I. Haworth). Chapter 32. Preclinical Safety Evaluation of Gene Therapy Products (Mercedes Serabian, and Ying Huang). Chapter 33. Preclinical Safety Evaluation of Cell-based Therapy Products (Joy A. Cavagnaro). Chapter 34. Preclinical Safety Evaluation of Combination Products (Bruce Babbitt, and Barry Sall). Chapter 35. Tissue-engineered Products: Preclinical Development of Neo-Organs (Timothy A. Bertram, and Manual Jayo). PART VII. PRECLINICAL STUDY DESIGN, IMPLEMENTATION AND ANALYSIS. Chapter 36. GLP Requirements and Current Practices (Tanya Scharton-Kersten). Chapter 37. Developing Preclinical Safety Programs: Study Design, Time, Costs (Gary Wolfe). Chapter 38. Practical Considerations in Implementation of Preclinical Assessment Programs for Biopharmaceuticals (Damon Demady). Chapter 39. Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals (Anita OConnor). PART VIII. TRANSITIONING FROM PRECLINICAL DEVELOPMENT TO CLINICAL TRIALS. Chapter 40. Selection of first human dose (Jennifer Visich and Rafael Ponce). Afterword (Anthony D. Dayan).

• ISBN: 978-0-470-10884-0
• Editorial: John Wiley & Sons
• Encuadernacion: Cartoné
• Páginas: 1033
• Fecha Publicación: 25/07/2008
• Nº Volúmenes: 1
• Idioma: Inglés