Knowledge Management and Process Monitoring of Pharmaceutical Processes in the Quality by Design Paradigm

2012 ◽  
pp. 217-247 ◽  
Author(s):  
Anurag S. Rathore ◽  
Anshuman Bansal ◽  
Jaspinder Hans
Keyword(s):  
Knowledge Management ◽  
Process Monitoring ◽  
Quality By Design ◽  
Design Paradigm ◽  
Pharmaceutical Processes

Process development in the Quality by Design paradigm: Modeling of Protein A chromatography resin fouling

2018 ◽  
Vol 1570 ◽  
pp. 56-66 ◽  
Author(s):  
Lalita Kanwar Shekhawat ◽  
Mili Pathak ◽  
Jayati Sakar ◽  
Anurag S. Rathore
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Protein A ◽  
Design Paradigm

Process Monitoring and Quality by Design for Biotechnology Products

2010 ◽  
Vol 1 (1) ◽  
pp. 1-38
Author(s):  
Neslihan Delacruz
Keyword(s):  
Process Monitoring ◽  
Quality By Design ◽  
Biotechnology Products

scholarly journals Best Practices for the Development, Scale-up, and Post-approval Change Control of IR and MR Dosage Forms in the Current Quality-by-Design Paradigm

2014 ◽  
Vol 15 (3) ◽  
pp. 665-693 ◽  
Author(s):  
Glenn A. Van Buskirk ◽  
Satish Asotra ◽  
Christopher Balducci ◽  
Prabir Basu ◽  
Gerald DiDonato ◽  
...  
Keyword(s):  
Best Practices ◽  
Quality By Design ◽  
Scale Up ◽  
Dosage Forms ◽  
Design Paradigm

scholarly journals Analytical Procedure Validation and the Quality by Design Paradigm

2014 ◽  
Vol 25 (2) ◽  
pp. 260-268 ◽  
Author(s):  
Eric Rozet ◽  
Pierre Lebrun ◽  
Jean-François Michiels ◽  
Perceval Sondag ◽  
Tara Scherder ◽  
...  
Keyword(s):  
Quality By Design ◽  
Analytical Procedure ◽  
Design Paradigm

Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm

2013 ◽  
Vol 67 (6) ◽  
pp. 569-580 ◽  
Author(s):  
D. Zalai ◽  
C. Dietzsch ◽  
C. Herwig
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Design Paradigm

scholarly journals Application of Absorption Modeling in Rational Design of Drug Product Under Quality-by-Design Paradigm

2015 ◽  
Vol 17 (5) ◽  
pp. 1224-1236 ◽  
Author(s):  
Filippos Kesisoglou ◽  
Amitava Mitra
Keyword(s):  
Rational Design ◽  
Quality By Design ◽  
Drug Product ◽  
Design Paradigm ◽  
Absorption Modeling
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