Methodologies in Biosimilar Product Development
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Published By Chapman And Hall/CRC

9781003205807
Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

Stability Studies

2021 ◽  
pp. 77-96
Author(s):  
Mo Liu ◽  
Yuqing Liu ◽  
Shein-Chung Chow
Keyword(s):  
Stability Studies

PK/PD Bridging Studies

2021 ◽  
pp. 159-172
Author(s):  
Fuyu Song ◽  
Xin Zheng ◽  
Shein-Chung Chow
Keyword(s):  
Bridging Studies

Sensitivity Analysis for Assessment of Extrapolation

2021 ◽  
pp. 253-275
Author(s):  
Junheng Gao ◽  
Chenxuan Zang ◽  
Ying Lyu ◽  
Shein-Chung Chow
Keyword(s):  
Sensitivity Analysis

Equivalence Test with Flexible Margin

2021 ◽  
pp. 115-133
Author(s):  
Sang Joon Lee ◽  
Minkyung Oh ◽  
Shein-Chung Chow
Keyword(s):  
Equivalence Test

CMC Considerations for Quality

2021 ◽  
pp. 23-41
Author(s):  
Shein-Chung Chow ◽  
Sanghee Kim ◽  
Wei Zhang

Non-Medical Switch

2021 ◽  
pp. 277-290
Author(s):  
Fuyu Song ◽  
He Bai ◽  
Peijin Wang ◽  
Shein-Chung Chow

Quality by Design

2021 ◽  
pp. 43-76
Author(s):  
Min Joo Choo ◽  
Ji Youn Kim ◽  
Shein-Chung Chow ◽  
Sang Joon Lee
Keyword(s):  
Quality By Design

Two One-Sided Tests Versus Confidence Interval Approach

2021 ◽  
pp. 97-113
Author(s):  
Jingyu Julia Luan ◽  
Weijia Mai ◽  
Shein-Chung Chow
Keyword(s):  
Confidence Interval ◽  
Interval Approach

Non-inferiority/Similarity Margin

2021 ◽  
pp. 173-204
Author(s):  
Jingyu Julia Luan ◽  
Wenyue Zhuo ◽  
Shein-Chung Chow

Detecting Reference Product Change in Biosimilar Studies

2021 ◽  
pp. 227-251
Author(s):  
Jiayin Zheng ◽  
Peijin Wang ◽  
Yixin Wang ◽  
Shein-Chung Chow
Keyword(s):  
Reference Product
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