Review: The Critical Role of Clinical Pharmacology in the Development of Biologics-Reference-Cited by-同舟云学术

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Review: The Critical Role of Clinical Pharmacology in the Development of Biologics

Published:2015-12-30 Issue: Volume: Page:1-16
ISSN:
Container-title:Pharmaceutical Sciences Encyclopedia
language:
Short-container-title:

Author:

Zhao Liang¹,Wang Diane²,Zhao Ping¹,Shang Elizabeth Y.¹,Wang Yaning¹,Sinha Vikram¹

Affiliation:

1. US Food and Drug Administration; Silver Spring MD USA

2. Pfizer Oncology; San Diego CA USA

Publisher

John Wiley & Sons, Inc.

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/9780470571224.pse560/fullpdf

Reference77 articles.

1. Novo Nordisk 2013 Levemir (package insert)

2. US Food and Drug Administration Draft Guidance for Industry Biosimilars 2012 Questions and answers regarding implementation of the biologics price competition and innovation act of 2009

3. US Food and Drug Administration Guidance for Industry 2010 Pharmacokinetics in patients with impaired renal function - study design, data analysis, and impact on dosing and labeling (Draft)

4. Antibody pharmacokinetics and pharmacodynamics;Lobo;J Pharm Sci,2004

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