Quality by design approach of a pharmaceutical gel manufacturing process, part 1: Determination of the design space

2011 ◽  
Vol 100 (10) ◽  
pp. 4432-4441 ◽  
Author(s):  
Juan G. Rosas ◽  
Marcel Blanco ◽  
Josep M. González ◽  
Manel Alcalá
Keyword(s):  
Manufacturing Process ◽  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
Quality By Design Approach

Application of the quality by design approach to the drug substance manufacturing process of an Fc fusion protein: Towards a global multi‐step design space

2012 ◽  
Vol 101 (10) ◽  
pp. 3604-3618 ◽  
Author(s):  
Alex Eon-Duval ◽  
Pascal Valax ◽  
Thomas Solacroup ◽  
Hervé Broly ◽  
Ralf Gleixner ◽  
...  
Keyword(s):  
Fusion Protein ◽  
Manufacturing Process ◽  
Quality By Design ◽  
Design Space ◽  
Drug Substance ◽  
Design Approach ◽  
Fc Fusion Protein ◽  
Quality By Design Approach

Innovative Quality by Design Approach for Development of Green Micellar HPLC Method for Simultaneous Determination of Atorvastatin and Amlodipine

2020 ◽  
Vol 83 (10) ◽  
pp. 1221-1231 ◽  
Author(s):  
Ahmed A. Habib ◽  
Sherin F. Hammad ◽  
Safa M. Megahed ◽  
Amira H. Kamal
Keyword(s):  
Simultaneous Determination ◽  
Quality By Design ◽  
Hplc Method ◽  
Design Approach ◽  
Quality By Design Approach

scholarly journals Quality by Design approach in the development of a magnetic transducer for biomedical measurements: preliminary results on Design Space configuration

2016 ◽  
Vol 772 ◽  
pp. 012016 ◽  
Author(s):  
D R Louzada ◽  
E C Monteiro ◽  
A M Rivero ◽  
L G S Fortaleza ◽  
C R H Barbosa ◽  
...  
Keyword(s):  
Quality By Design ◽  
Design Space ◽  
Design Approach ◽  
Preliminary Results ◽  
Magnetic Transducer ◽  
Quality By Design Approach ◽  
Biomedical Measurements

Using an innovative quality-by-design approach for the development of a stability-indicating UPLC/Q-TOF-ESI-MS/MS method for stressed degradation products of imatinib mesylate

RSC Advances ◽  
2016 ◽  
Vol 6 (16) ◽  
pp. 13050-13062 ◽  
Author(s):  
Zhihui Ren ◽  
Xiaoxi Zhang ◽  
Haiyuan Wang ◽  
Xinghua Jin
Keyword(s):  
Simultaneous Determination ◽  
Imatinib Mesylate ◽  
Quality By Design ◽  
Degradation Products ◽  
Design Approach ◽  
Design Expert ◽  
Stability Indicating ◽  
Esi Ms ◽  
Quality By Design Approach

Chromatography modeling softwares (DryLab®2000 plus and Design Expert®​8.0.6) were used to develop a stability indicating UPLC/Q-TOF-ESI-MS/MS method for the simultaneous determination of stressed degradation products of imatinib mesylate.​

Application of quality by design approach for HPTLC simultaneous determination of amlodipine and celecoxib in presence of process-related impurity

2021 ◽  
Vol 162 ◽  
pp. 105857
Author(s):  
Khaled Attala ◽  
Maya S. Eissa ◽  
Magda M. El-Henawee ◽  
Soad S. Abd El-Hay
Keyword(s):  
Simultaneous Determination ◽  
Quality By Design ◽  
Design Approach ◽  
Quality By Design Approach

Cyclodextrin- and solvent-modified micellar electrokinetic chromatography for the determination of captopril, hydrochlorothiazide and their impurities: A Quality by Design approach

Talanta ◽  
2016 ◽  
Vol 160 ◽  
pp. 332-339 ◽  
Author(s):  
Benedetta Pasquini ◽  
Serena Orlandini ◽  
Claudia Caprini ◽  
Massimo Del Bubba ◽  
Massimo Innocenti ◽  
...  
Keyword(s):  
Quality By Design ◽  
Micellar Electrokinetic Chromatography ◽  
Design Approach ◽  
Electrokinetic Chromatography ◽  
Quality By Design Approach
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