Preclinical safety evaluation of biopharmaceuticals: a science-based approach to facilitating clinical trials
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Hoboken, N.J.
Wiley
2008
|
| Schlagworte: | |
| Online-Zugang: | Publisher description Table of contents only Contributor biographical information Inhaltsverzeichnis |
| Beschreibung: | Includes bibliographical references and index |
| Beschreibung: | XXVI, 1033 S., [4] Bl. Ill., graph. Darst. cm |
| ISBN: | 9780470108840 |
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| 245 | 1 | 0 | |a Preclinical safety evaluation of biopharmaceuticals |b a science-based approach to facilitating clinical trials |c ed. by Joy A. Cavagnaro |
| 264 | 1 | |a Hoboken, N.J. |b Wiley |c 2008 | |
| 300 | |a XXVI, 1033 S., [4] Bl. |b Ill., graph. Darst. |c cm | ||
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| 650 | 4 | |a Clinical Trials as Topic |x methods | |
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Datensatz im Suchindex
| _version_ | 1804138922547085312 |
|---|---|
| adam_text | ¦¦^H CONTENTS
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)
v
Vi CONTENTS
PART III CURRENT PRACTICES IN PRECLINICAL
DEVELOPMENT 123
7. Comparison of Predinical 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 Idee)
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.),
ShariA. 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
(Biologies Consulting Group, Inc.)
13. Use of Animal Models of Disease in the Predinical Safety
Evaluation of Biopharmaceuticals 293
Johan te Koppele, PhD (TNO Quality of Life) and Renger Witkamp, PhD
(Wageningen University, The Netherlands)
CONTENTS Vii
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)
Yl. 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 ToddJ. Page, PhD (Eli Lilly)
23. Enzyme Replacement Therapies 517
Laura Andrews, PhD, DABT (Genzyme), and Michael O Callaghan,
DVM, PhD, MRCVS (Genzyme)
Viii CONTENTS
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 (his)
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,
DPMI (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 Sail (Parexel Consulting)
35. Tissue Engineered Products: Preclinical Development of
Neo-Organs 799
Timothy A. Bertram, DVM, PhD, and Manuel Jayo, DVM, PhD (Tengion)
CONTENTS iX
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 (Zy mo genetics)
PART IX AFTERWORD 985
A Retrospective 987
Anthony D. Dayan, LLB, MD, FRCP, FRCPath, FFOM, FFPM, FIBiol
INDEX 999
|
| any_adam_object | 1 |
| building | Verbundindex |
| bvnumber | BV035465663 |
| callnumber-first | R - Medicine |
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| callnumber-raw | RS380 |
| callnumber-search | RS380 |
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| callnumber-subject | RS - Pharmacy |
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| dewey-full | 615/.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.19 |
| dewey-search | 615/.19 |
| dewey-sort | 3615 219 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Chemie Chemie-Ingenieurwesen Medizin |
| format | Book |
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| indexdate | 2024-07-09T21:35:53Z |
| institution | BVB |
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| publisher | Wiley |
| record_format | marc |
| spelling | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials ed. by Joy A. Cavagnaro Hoboken, N.J. Wiley 2008 XXVI, 1033 S., [4] Bl. Ill., graph. Darst. cm txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Pharmaceutical biotechnology Safety measures Drugs Testing Clinical Trials as Topic methods Biological Products Clinical Trials as Topic legislation & jurisprudence Drug Evaluation, Preclinical methods Biologika (DE-588)7689632-8 gnd rswk-swf Arzneimittelüberwachung (DE-588)4437717-4 gnd rswk-swf Pharmazeutische Chemie (DE-588)4132158-3 gnd rswk-swf Bioverfahrenstechnik (DE-588)4307166-1 gnd rswk-swf Klinisches Experiment (DE-588)4164223-5 gnd rswk-swf Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf Arzneimitteldesign (DE-588)4278218-1 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Pharmazeutische Chemie (DE-588)4132158-3 s Biologika (DE-588)7689632-8 s Bioverfahrenstechnik (DE-588)4307166-1 s Arzneimitteldesign (DE-588)4278218-1 s Arzneimittelsicherheit (DE-588)4143182-0 s Arzneimittelüberwachung (DE-588)4437717-4 s Klinisches Experiment (DE-588)4164223-5 s b DE-604 Cavagnaro, Joy A. Sonstige oth http://www.loc.gov/catdir/enhancements/fy0808/2007050275-d.html Publisher description http://www.loc.gov/catdir/enhancements/fy0808/2007050275-t.html Table of contents only http://www.loc.gov/catdir/enhancements/fy0834/2007050275-b.html Contributor biographical information HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017385423&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials Pharmaceutical biotechnology Safety measures Drugs Testing Clinical Trials as Topic methods Biological Products Clinical Trials as Topic legislation & jurisprudence Drug Evaluation, Preclinical methods Biologika (DE-588)7689632-8 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd Pharmazeutische Chemie (DE-588)4132158-3 gnd Bioverfahrenstechnik (DE-588)4307166-1 gnd Klinisches Experiment (DE-588)4164223-5 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd Arzneimitteldesign (DE-588)4278218-1 gnd |
| subject_GND | (DE-588)7689632-8 (DE-588)4437717-4 (DE-588)4132158-3 (DE-588)4307166-1 (DE-588)4164223-5 (DE-588)4143182-0 (DE-588)4278218-1 (DE-588)4143413-4 |
| title | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials |
| title_auth | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials |
| title_exact_search | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials |
| title_full | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials ed. by Joy A. Cavagnaro |
| title_fullStr | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials ed. by Joy A. Cavagnaro |
| title_full_unstemmed | Preclinical safety evaluation of biopharmaceuticals a science-based approach to facilitating clinical trials ed. by Joy A. Cavagnaro |
| title_short | Preclinical safety evaluation of biopharmaceuticals |
| title_sort | preclinical safety evaluation of biopharmaceuticals a science based approach to facilitating clinical trials |
| title_sub | a science-based approach to facilitating clinical trials |
| topic | Pharmaceutical biotechnology Safety measures Drugs Testing Clinical Trials as Topic methods Biological Products Clinical Trials as Topic legislation & jurisprudence Drug Evaluation, Preclinical methods Biologika (DE-588)7689632-8 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd Pharmazeutische Chemie (DE-588)4132158-3 gnd Bioverfahrenstechnik (DE-588)4307166-1 gnd Klinisches Experiment (DE-588)4164223-5 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd Arzneimitteldesign (DE-588)4278218-1 gnd |
| topic_facet | Pharmaceutical biotechnology Safety measures Drugs Testing Clinical Trials as Topic methods Biological Products Clinical Trials as Topic legislation & jurisprudence Drug Evaluation, Preclinical methods Biologika Arzneimittelüberwachung Pharmazeutische Chemie Bioverfahrenstechnik Klinisches Experiment Arzneimittelsicherheit Arzneimitteldesign Aufsatzsammlung |
| url | http://www.loc.gov/catdir/enhancements/fy0808/2007050275-d.html http://www.loc.gov/catdir/enhancements/fy0808/2007050275-t.html http://www.loc.gov/catdir/enhancements/fy0834/2007050275-b.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=017385423&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT cavagnarojoya preclinicalsafetyevaluationofbiopharmaceuticalsasciencebasedapproachtofacilitatingclinicaltrials |