Application of Quality by Design Principles to Support Development of a Control Strategy for the Control of Genotoxic Impurities in the Manufacturing Process of a Drug Substance

2010 ◽  
Vol 14 (4) ◽  
pp. 993-998 ◽  
Author(s):  
Zadeo Cimarosti ◽  
Fernando Bravo ◽  
Paul Stonestreet ◽  
Francesco Tinazzi ◽  
Orsola Vecchi ◽  
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Keyword(s):  
Control Strategy ◽  
Manufacturing Process ◽  
Quality By Design ◽  
Design Principles ◽  
Drug Substance ◽  
Genotoxic Impurities

Integrated Application of Quality-by-Design Principles to Drug Product and Its Control Strategy Development

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Author(s):  
Sherif I.F. Badawy ◽  
Ajit S. Narang ◽  
Keirnan R. LaMarche ◽  
Ganeshkumar A. Subramanian ◽  
Sailesh A. Varia ◽  
...  
Keyword(s):  
Control Strategy ◽  
Quality By Design ◽  
Drug Product ◽  
Design Principles ◽  
Strategy Development

Determination of critical quality attributes for monoclonal antibodies using quality by design principles

Biologicals ◽  
2016 ◽  
Vol 44 (5) ◽  
pp. 291-305 ◽  
Author(s):  
Nadja Alt ◽  
Taylor Y. Zhang ◽  
Paul Motchnik ◽  
Ron Taticek ◽  
Valerie Quarmby ◽  
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Keyword(s):  
Monoclonal Antibodies ◽  
Quality By Design ◽  
Design Principles ◽  
Quality Attributes ◽  
Critical Quality Attributes

scholarly journals Low Level Quantification of Potential Genotoxic Impurities In Telmisartan Drug Substance by HPLC

2021 ◽  
Vol 11 (3) ◽  
pp. 24-35
Author(s):  
K. Srivalli ◽  
N. Annapurna ◽  
K. Raghu Babu ◽  
C. Ramdas ◽  
Hemant Kumar Sharma ◽  
...  
Keyword(s):  
Drug Substance ◽  
Low Level ◽  
Genotoxic Impurities
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