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

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

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

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

Assignment Scenarios

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09994-6 ◽

2018 ◽

pp. 163-166

Alternative Regulatory Pathways and Special Programs

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00007-9 ◽

2018 ◽

pp. 99-117

Author(s):

Rebecca Sheets

Keyword(s):

Regulatory Pathways ◽

Special Programs

Good “X” Practices

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.00010-9 ◽

2018 ◽

pp. 145-158

Author(s):

Rebecca Sheets

How to Obtain Documents From ICH and US

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09993-4 ◽

2018 ◽

pp. 1

Introduction

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09983-1 ◽

2018 ◽

pp. 3

Author(s):

Rebecca Sheets

Acknowledgments

Fundamentals of Biologicals Regulation ◽

10.1016/b978-0-12-809290-3.09985-5 ◽

2018 ◽

pp. xxvii