Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics
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9780123948106

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Novel Biopharmaceuticals

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00004-6 ◽

2013 ◽

pp. 97-137 ◽

Author(s):

Melinda Marian ◽

Wolfgang Seghezzi

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Blood Products

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00012-5 ◽

2013 ◽

pp. 287-301 ◽

Author(s):

Inge A. Ivens ◽

Vikram Arora

Keyword(s):

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Nonclinical Development of Multi-targeting Biopharmaceuticals

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00014-9 ◽

2013 ◽

pp. 343-371 ◽

Author(s):

Rodney A. Prell ◽

Donna W. Lee ◽

Wendy G. Halpern ◽

Anu V. Connor

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Turning the Corner with Viral-based Gene Therapy—Development of the Rogue Biopharmaceutical

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00011-3 ◽

2013 ◽

pp. 259-285 ◽

Author(s):

Timothy K. MacLachlan

Keyword(s):

Gene Therapy ◽

Therapy Development

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Color Plates

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00195-7 ◽

2013 ◽

pp. 1-7

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Index

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.18001-3 ◽

2013 ◽

pp. 409-416

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Contributors

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.01002-9 ◽

2013 ◽

pp. xiii

Author(s):

Vikram Arora ◽

Eugene P. Brandon ◽

Joy A. Cavagnaro ◽

Anu V. Connor ◽

Justine J. Cunningham ◽

...

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Special Considerations for the Nonclinical Safety Assessment of Vaccines

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00010-1 ◽

2013 ◽

pp. 243-255 ◽

Author(s):

Jayanthi J. Wolf

Keyword(s):

Safety Assessment

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Early Characterization of Biosimilar Therapeutics

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00007-1 ◽

2013 ◽

pp. 185-210

Author(s):

Thomas R. Gelzleichter

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Global Regulatory Guidelines for Vaccines

Nonclinical Development of Novel Biologics, Biosimilars, Vaccines and Specialty Biologics ◽

10.1016/b978-0-12-394810-6.00009-5 ◽

2013 ◽

pp. 225-241 ◽

Author(s):

Lisa M. Plitnick

Keyword(s):

Regulatory Guidelines

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