Preclinical Safety Evaluation of Biopharmaceuticals (eBook, ePUB)

A Science-Based Approach to Facilitating Clinical Trials
Redaktion: Cavagnaro, Joy A.

• Format: ePub

Produktbeschreibung

"The goal is to provide a comprehensive reference book for the preclinicaldiscovery and development scientist whose responsibilities span target identification, lead candidate selection, pharmacokinetics, pharmacology, and toxicology, and for regulatory scientists whose responsibilities include the evaluation of novel therapies."
-From the Afterword by Anthony D. Dayan

Proper preclinical safety evaluation can improve the predictive value, lessen the time and cost of launching new biopharmaceuticals, and speed potentially lifesaving drugs to market. This guide covers topics ranging from lead candidate selection to establishing proof of concept and toxicity testing to the selection of the first human doses. With chapters contributed by experts in their specific areas, Preclinical Safety Evaluation 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.

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in D ausgeliefert werden.

Produktdetails

• Verlag: John Wiley & Sons
• Erscheinungstermin: 7. März 2013
• Englisch
• ISBN-13: 9781118679388
• Artikelnr.: 37759543

Autorenporträt

Joy A. Cavagnaro, PhD, is the President of Access BIO, a consultancy specializing in science-based regulatory strategies and product development services. She has over twenty-five years of experience in biotech spanning academia, the CRO and biotech industries, and government. During her tenure at the FDA, Dr. Cavagnaro served as rapporteur for ICH S6. She is founder and past chair of the BIO Preclinical Safety Expert Group (BioSafe) and was the U.S. BIO Representative to the 2006 ABPI/BIA Early Stage Clinical Trials Taskforce.Dr. Cavagnaro is currently North American Chair of the Drug Information Association-Biotech SIAC and Chair of the Clinical and Regulatory Affairs Committee of the American Society of Gene Therapy. She serves on a number of scientific advisory boards and lectures internationally in the area of preclinical development of novel therapies.

Inhaltsangabe

Foreword xi Joy A. Cavagnaro
PhD
DABT
RAC
and Anthony D. Dayan
LLB
MD
FRCP
FRCPath
FFOM
FFPM
FIBiol Acknowledgments xix Contributors xxi  Part I Background 1 1. Biopharmaceuticals: Definition and Regulation 3 Lincoln Tsang
PhD
FRSC
FIBiol
FRPharmS (Arnold and Porter
London
UK)
and Nathan Cortez (Southern Methodist University) 2. Methods of Production of Biopharmaceutical Products and Assessment of Environmental Impact 21 Patricia D. Williams
PhD (Summit Drug Development Services) Part II Principles of Preclinical Development 43 3. The Principles of ICH S6 and the Case-by-Case Approach 45 Joy A. Cavagnaro
PhD
DABT
RAC (Access BIO) 4. Implementation of ICH S6: EU Perspective 67 Peter R. Ryle
PhD
DipRCPath (Tox)
FRCPath (PR BioServices)
and David J. Snodin
PhD
FRSC
MChemA
MSc (Parexel Consulting) 5. Implementation of ICH S6: Japanese Perspective 93 Takahiro Nakazawa
PhD (Eli Lilly Japan) 6. Implementation of ICH S6: US Perspective 111 Mary Ellen Cosenza
PhD
MS
DABT
RAC (Amgen) Part III Current Practices in Preclinical Development 123 7. Comparison of Preclinical Development Programs for Small Molecules (Drugs/Pharmaceuticals) and Large Molecules (Biologics/Biopharmaceuticals): Studies
Timing
Materials
and Costs 125 Christopher Horvath
DVM
MS
DACVP (Archemix Corp.) 8. Demonstration of Comparability of a Licensed Product after a Manufacturing Change 161 Richard M. Lewis
PhD (Access BIO) Part IV Selection of Relevant Species 179 9. Selection of Relevant Species 181 Meena Subramanyam
PhD
Nicola Rinaldi
PhD
Elisabeth Mertsching
PhD
and David Hutto
PhD
DVM (Biogen Idec) 10. Tissue Cross-Reactivity Studies for Monoclonal Antibodies: Predictive Value and Use for Selection of Relevant Animal Species for Toxicity Testing 207 William C. Hall
VMD
PhD
DACVP (Hall Consulting Inc.)
Shari A. Price-Schiavi
PhD
DABT (Charles River Laboratories-PAI)
Joan Wicks
DVM
PhD
DACVP (Charles River Laboratories-PAI)
and Jennifer L. Rojko
DVM
PhD
DACVP (Charles River Laboratories-PAI) 11. Physiologic IgG Biodistribution
Transport
and Clearance: Implications for Monoclonal Antibody Products 241 Jennifer L. Rojko
DVM
PhD
DACVP
and Shari Price-Schiavi
PhD
DABT (Charles River Laboratories-PAI) 12. The Role of Pharmacokinetics and Pharmacodynamics in Selecting a Relevant Species 277 Martin D. Green
PhD (FDA)
and Melanie Hartsough
PhD (Biologics Consulting Group
Inc.) 13. Use of Animal Models of Disease in the Preclinical Safety Evaluation of Biopharmaceuticals 293 Johan te Koppele
PhD (TNO Quality of Life) and Renger Witkamp
PhD (Wageningen University
The Netherlands) Part V Safety/toxicity Endpoints 309 14. Safety Pharmacology: Similarities and Differences between Small Molecules and Novel Biopharmaceuticals 311 Edward W. Bernton
MD (Pathway Pharmacology) 15. Genetic Toxicology Testing of Biopharmaceuticals 337 David Jacobson-Kram
PhD
DABT
and Hanan Ghantous
PhD
Dabt (fda) 16. General Toxicity Testing and Immunotoxicity Testing for Biopharmaceuticals 343 Jeanine L. Bussiere
PhD
DABT (Amgen) 17. Reproductive Toxicity Testing for Biopharmaceuticals 357 Pauline L. Martin
PhD (Centocor Research and Development Inc.) 18. Reproductive/Developmental Toxicity Assessment of Biopharmaceuticals in Nonhuman Primates 379 Gerhard F. Weinbauer
PhD
Werner Frings
PhD
Antje Fuchs
PhD
Michael Niehaus
PhD
and Ingrid Osterburg (Covance
Germany) 19. Preclinical Evaluation of Cancer Hazard and Risk of Biopharmaceuticals 399 Joy A. Cavagnaro
PhD
DABT
RAC (Access BIO) 20. Immunogenicity of Therapeutic Proteins and the Assessment of Risk 475 Huub Schellekens
MD
PhD (Utrecht University)
and Wim Jiskoot
PhD (Leiden University) 21. Assessment of Autoimmunity and Hypersensitivity 487 Jacques Descotes
md
PharmD
PhD
and Thierry Vial
md (Poison Centere and Pharmacovigilance Unit
Lyon
France) Part VI Specific Considerations Based on Product Class 499 22. Current Practices in the Preclinical Safety Assessment of Peptides 501 Shawn M. Heidel
DVM
PhD
and Todd J. Page
PhD (Eli Lilly) 23. Enzyme Replacement Therapies 517 Laura Andrews
PhD
DABT (Genzyme)
and Michael O'Callaghan
DVM
PhD
MRCVS (Genzyme) 24. Toxicology of Oligonucleotide Therapeutics and Understanding the Relevance of the Toxicities 537 Arthur A. Levin
PhD
DABT (Biotech & Pharmaceutical Consulting)
and Scott P. Henry
PhD
DABT (Isis) 25. Preclinical Safety Evaluation of Biological Oncology Drugs 575 Theresa Reynolds
BA
DABT (Genentech) 26. Preclinical Safety Evaluation of Monoclonal Antibodies 587 George Treacy
MS
and Pauline Martin
PhD (Centocor Research and Development) 27. Immunomodulatory Biopharmaceuticals and Risk of Neoplasia 601 Peter J. Bugelski
PhD
FRCPath
Clifford Sachs
PhD
DABT
Joel Cornacoff
DVM
PhD
DABT
Pauline Martin
PhD
and George Treacy
MS (Centocor Research and Development) 28. Strategy Considerations for Developing the Preclinical Safety Testing Programs for Protein Scaffold Therapeutics 633 Stanley A. Roberts
PhD
DABT
Gary Woodnutt
PhD
and Curt W. Bradshaw
PhD (CovX Research
LLC) 29. Preclinical Safety Evaluation of Immunotoxins 649 Jennifer G. Brown
PhD
Joycelyn Entwistle
PhD
Nick Glover
PhD
and Glen C. MacDonald
PhD (Viventia Biotech
Inc) 30. Preclinical Safety Evaluation of Blood Products 669 Richard M. Lewis
PhD (Access BIO) 31. Preclinical Safety Evaluation of Viral Vaccines 683 A. Marguerite Dempster
PhD
DABT
and Richard Haworth
FRCPath
DPhil (GlaxoSmithKline) 32. Preclinical Safety Evaluation of Biopharmaceuticals 713 Mercedes A. Serabian
MS
DABT
and Ying Huang
PhD (FDA) 33. Considerations in Design of Preclinical Safety Evaluation Programs to Support Human Cell-Based Therapies 749 Joy A. Cavagnaro
PhD
DABT
RAC (Access BIO) 34. Preclinical Safety Evaluation of Biopharmaceuticals: Combination Products (Biologic/Device) 783 Bruce Babbitt
PhD
and Barry Sall (Parexel Consulting) 35. Tissue Engineered Products: Preclinical Development of Neo-Organs 799 Timothy A. Bertram
DVM
PhD
and Manuel Jayo
DVM
PhD (Tengion) Part VII Preclinical Study Design
Implementation
and Analysis 827 36. GLP Requirements and Current Practices 829 Tanya Scharton-Kersten (Novartis) 37. Preclinical Safety Study Design Templates and Estimated Costs 851 Gary W. Wolfe
PhD
DABT (Summit Drug Development Services) 38. Practical Considerations in the Design of Preclinical Safety Assessments for Biopharmaceuticals 913 Damon R. Demady
PhD (Knopp Neurosciences) 39. Survey of Preclinical Toxicology Programs for Approved Biopharmaceuticals 931 Anita Marie O'Connor
PhD (Anita O'Connor Consulting
LLC) Part VIII Transitioning From Preclinical Development to Clinical Trials 969 40. Science and Judgment in Establishing a Safe Starting Dose for First-in-Human Trials of Biopharmaceuticals 971 Jennifer Visich
PhD (Genentech)
and Rafael Ponce
PhD
DABT (Zymogenetics) Part IX Afterword 985 A Retrospective 987 Anthony D. Dayan
LLB
MD
FRCP
FRCPath
FFOM
FFPM
FIBiol Index 999