Nonclinical Development of Novel Biologics, Biosimilars and Specialty Biologics

Content: 
Front Matter, Page iii
Copyright, Page iv
Dedication, Page v
Preface, Page xi
Contributors, Page xiii, Vikram Arora, Eugene P. Brandon, Joy A. Cavagnaro, Anu V. Connor, Justine J. Cunningham, Maggie Dempster, Christina de Zafra, Thomas R. Gelzleichter, Wendy G. Halpern, Danuta J. Herzyk, Beth Hinkle, Inge A. Ivens, Amy Kim, Donna W. Lee, Timothy K. MacLachlan, Melinda Marian, Barbara Mounho-Zamora, Padma Kumar Narayanan, Rania Nasis, Deborah L. Novicki,  et al.
Acknowledgments, Page xv
Chapter 1 - Overview of Biopharmaceuticals and Comparison with Small-molecule Drug Development, Pages 3-33, Theresa Reynolds, Christina de Zafra, Amy Kim, Thomas R. Gelzleichter
Chapter 2 - Regulatory Guidelines and their Application in the Nonclinical Evaluation of Biological Medicines, Pages 35-64, Marque D. Todd, Maggie Dempster
Chapter 3 - Early De-risking Strategy for Novel Biotherapeutics, Pages 65-95, Padma Kumar Narayanan, Rafael Ponce, Beth Hinkle
Chapter 4 - Novel Biopharmaceuticals: Pharmacokinetics, Pharmacodynamics, and Bioanalytics, Pages 97-137, Melinda Marian, Wolfgang Seghezzi
Chapter 5 - Overview of Biosimilar Therapeutics, Pages 141-157, Danuta J. Herzyk
Chapter 6 - Regulatory Standards for the Approval of Biosimilar Products: A Global Review, Pages 159-184, Barbara Mounho-Zamora
Chapter 7 - Early Characterization of Biosimilar Therapeutics, Pages 185-210, Thomas R. Gelzleichter
Chapter 8 - Introduction to Vaccines and Adjuvants, Pages 213-224, Deborah L. Novicki
Chapter 9 - Global Regulatory Guidelines for Vaccines, Pages 225-241, Lisa M. Plitnick
Chapter 10 - Special Considerations for the Nonclinical Safety Assessment of Vaccines, Pages 243-255, Jayanthi J. Wolf
Chapter 11 - Turning the Corner with Viral-based Gene Therapy—Development of the Rogue Biopharmaceutical, Pages 259-285, Timothy K. MacLachlan
Chapter 12 - Blood Products, Pages 287-301, Inge A. Ivens, Vikram Arora
Chapter 13 - Biological Therapies for Cancer, Pages 303-342, Karen D. Price, Gautham K. Rao
Chapter 14 - Nonclinical Development of Multi-targeting Biopharmaceuticals, Pages 343-371, Rodney A. Prell, Donna W. Lee, Wendy G. Halpern, Anu V. Connor
Chapter 15 - Considerations in the Development of Pluripotent Stem Cell-based Therapies, Pages 373-408, Rania Nasis, Justine J. Cunningham, Eugene P. Brandon, Joy A. Cavagnaro
Color Plates, Pages 1-7
Index, Pages 409-416