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Author: Robert A. Lionberger, Sau Lawrence Lee, LaiMing Lee, Andre Raw, Lawrence X. Yu
Keywords: control strategy,critical material attributes,critical process parameters,design space,quality by design Summary: Quality by design is an essential part of the modern approach to pharmaceutical quality. nomenclature for quality by design, critical quality attribute, critical process parameter, critica quality by design.
The AAPS Journal; Vol. 10 Number 2, Jun 2008;Published Date:05/31/2008; DOI: 10.1208/s12248-008-9026-7
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Author: Lawrence X. Yu
Keywords: pharmaceutical quality by design,pharmaceutical quality by testing,process control,process design,process parameter,process variability,product design,quality attribute,question-based review Summary: The purpose of this paper is to discuss the pharmaceutical Quality by Design (QbD) and
pharmaceutical quality by design; pharmaceutical quality by testing; process control; CGMPs for the twenty-first century and quality by design
Pharmaceutical Research; Vol. 25 Number 4, Apr 2008;Published Date:03/31/2008; DOI: 10.1007/s11095-007-9511-1
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Author: Rong-Kun Chang, Andre Raw, Robert Lionberger, Lawrence Yu
Keywords: dermatologic product,generic,quality by design,semisolid,topical product Summary: Quality by design begins with defining a quality target product profile as well as critical quality drug; QbD, Quality by design; QbT, Quality by testing; CMA, Critical material attribute; CPP, Criti inspected into a quality product and quality attributes should be designed via the thorough underst
; DOI: 10.1208/s12248-013-9472-8
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Author: André Sirota Raw, Robert Lionberger, Lawrence X. Yu
Keywords: generic drugs,modified release,pharmaceutical equivalence,quality by design (QbD),quality target product profile (QTPP),therapeutic equivalence Summary: Century and Quality by Design (QbD) initiatives are meant
quality by design initiative (QbD) provides an enhanced evaluation
quality by design (QbD)
Pharmaceutical Research; Vol. 28 Number 7, Jul 2011;Published Date:06/30/2011; DOI: 10.1007/s11095-011-0397-6
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Author: Lei Zhang, Binjun Yan, Xingchu Gong, Lawrence X. Yu, Haibin Qu
Keywords: botanical drug products,design of experiments (DOE),design space,ethanol precipitation,quality by design (QbD) Summary: This paper was designed to assess the value of quality by design (QbD) to improve the manufacturing drug products; design of experiments (DOE); design space; ethanol precipitation; quality by design the concept of quality by design (QbD) has become a topic of high importance in pharmaceutical indu
AAPS PharmSciTech; Vol. 14 Number 1, Mar 2013;Published Date:02/28/2013; DOI: 10.1208/s12249-012-9919-8
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Author: Bryan S. Riley, Xuhong Li
Keywords: process analytical technology (PAT),quality by design (QbD),sterile product Summary: Quality by Design and Process Analytical Technology for Sterile Products- process analytical technology (PAT); quality by design (QbD); sterile product. to implementing the knowledge gained from quality by design in
AAPS PharmSciTech; Vol. 12 Number 1, Mar 2011;Published Date:02/28/2011; DOI: 10.1208/s12249-010-9566-x
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Author: Evdokia Korakianiti, Dimitrios Rekkas
Keywords: design of experiments,knowledge management,process analytical technologies,process variability,quality,quality by design,statistical process control and analysis,statistical thinking Summary: quality by design Quality by Design (QbD), the main principle of which is the
quality and how they can be used by the pharmaceutical
Pharmaceutical Research; Vol. 28 Number 7, Jul 2011;Published Date:06/30/2011; DOI: 10.1007/s11095-010-0315-3
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Author: Raafat Fahmy, Ravikanth Kona, Ramesh Dandu, Walter Xie, Gregg Claycamp, Stephen W. Hoag
Keywords: failure mode effect analysis (FMEA),Plackett–Burman,quality by design (QbD),quality risk management,roller compaction,tablet and ciprofloxacin Summary: Results show that by using prior experience, literature data, and preformulation data the number of Plackett�Burman; quality by design (QbD); quality risk management; roller compaction; tablet and ci new drug using the Quality by Design (QbD) paradigm as outlined in the ICH Q8(R2), Q9, and Q10 guid
AAPS PharmSciTech; Vol. 13 Number 4, Dec 2012;Published Date:11/30/2012; DOI: 10.1208/s12249-012-9844-x
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