Sign In  |  Register  

Search results:

Can't find what you're looking for? Try an Advanced Search

Results 1 to 8 of about 1024
These results are based on your search on the following terms:
Text: quality by design
All Journals
Sort by: Relevance | Date
Quality by Design: Concepts for ANDAs
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
Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control
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
Generic Development of Topical Dermatologic Products, Part II: Quality by Design for Topical Semisolid Products
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
Pharmaceutical Equivalence by Design for Generic Drugs: Modified-Release Products
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
Application of Quality by Design to the Process Development of Botanical Drug Products: A Case Study
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
Quality by Design and Process Analytical Technology for Sterile Products—Where Are We Now?
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
Statistical Thinking and Knowledge Management for Quality-Driven Design and Manufacturing in Pharmaceuticals
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
Quality by Design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett–Burman Design of Experiments in the Identification of “Main Factors” in the Formulation and Process Design Space for Roller-Compacted Ciprofloxacin Hydrochloride Immediate-Release Tablets
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
<< First | < Previous | | Page 1 of 128 | Next > | Last >>