Fundamentals of Biologicals Regulation
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Published By Elsevier

9780128092903

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Front Matter

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09989-2 ◽

2018 ◽

pp. i-ii

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Marketing Authorization

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00006-7 ◽

2018 ◽

pp. 79-98

Author(s):

Rebecca Sheets

Keyword(s):

Marketing Authorization

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How to Obtain Documents From ICH and US

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09993-4 ◽

2018 ◽

pp. 1

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Introduction

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09983-1 ◽

2018 ◽

pp. 3

Author(s):

Rebecca Sheets

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International Biologicals Regulation: Vaccines, Biotechnology Medicines By Rebecca L. Sheets Compilation of Weblinks

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09991-0 ◽

2018 ◽

pp. 391-413

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Discovery and Development

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00002-x ◽

2018 ◽

pp. 19-27

Author(s):

Rebecca Sheets

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Risk Assessments

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00014-6 ◽

2018 ◽

pp. 219-229

Author(s):

Rebecca Sheets

Keyword(s):

Risk Assessments

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Written Assignments Exercise

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09992-2 ◽

2018 ◽

pp. 159-161

Keyword(s):

Written Assignments

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Preclinical Safety and Toxicology

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00011-0 ◽

2018 ◽

pp. 171-196

Author(s):

Rebecca Sheets

Keyword(s):

Preclinical Safety

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Preclinical Pharmacology, Proof-of-Principle

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00012-2 ◽

2018 ◽

pp. 197-208

Author(s):

Rebecca Sheets

Keyword(s):

Preclinical Pharmacology ◽

Proof Of Principle

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