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Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases
book

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

by Honghui Zhou, Diane R. Mould
March 2019
Intermediate to advanced content levelIntermediate to advanced
496 pages
15h
English
Wiley
Content preview from Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune-Mediated Inflammatory Diseases

16Vedolizumab—A Case Example of Using Quantitative Pharmacology in Developing Therapeutic Biologics in Inflammatory Bowel Disease

Maria Rosario1Nathanael L. Dirks2Diane R. Mould3Catherine Scholz4Timothy Wyant5Asit Parikh6 and Irving Fox6

1Takeda Development Center Americas, Inc., Cambridge, MA, 02139, USA

2Metrum Research Group, Tariffville, CT, 06081, USA

3Projections Research Inc., Phoenixville, PA, 19460, USA

4Kura Oncology, Cambridge, MA, 02142, USA

5Curis, Inc., Lexington, MA, 02421, USA

6Takeda Pharmaceuticals International Co., Cambridge, MA, 02139, USA

Abbreviations

AVA
anti‐vedolizumab antibody
BW
body weight
Caverage
average concentration
CD
Crohn's disease
CDAI
Crohn's Disease Activity Index
CI
confidence interval
CL
clearance
CLL
linear clearance
CLNL
nonlinear clearance
CLtotal
total clearance
CRP
C‐reactive protein
Ctrough
trough concentration
CV
coefficient of variation
Fc
fragment crystallizable (of antibody heavy chain)
FcRn
neonatal Fc receptor
IgG
immunoglobulin G
ITT
intent‐to‐treat
IV
intravenous
Km
concentration at half maximum elimination rate
mAb
monoclonal antibody
MAdCAM‐1
mucosal addressin cell adhesion molecule‐1
PK
pharmacokinetic
Q
intercompartmental clearance
Q4W
every 4 weeks
Q8W
every 8 weeks
TNF
tumor necrosis factor
UC
ulcerative colitis
VCAM‐1
vascular cell adhesion molecule‐1
Vc
central volume of distribution
Vp
peripheral volume of distribution
Vmax
maximum elimination rate

16.1 Introduction

Vedolizumab (ENTYVIO®, Takeda) is a humanized ...

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Publisher Resources

ISBN: 9781119289197Purchase book