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  1. Journal of Pharmaceutical Innovation
  2. Journal of Pharmaceutical Innovation : Volume 3
  3. Journal of Pharmaceutical Innovation : Volume 3, Issue 2, June 2008
  4. PQLI Design Space
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Journal of Pharmaceutical Innovation : Volume 12
Journal of Pharmaceutical Innovation : Volume 11
Journal of Pharmaceutical Innovation : Volume 10
Journal of Pharmaceutical Innovation : Volume 9
Journal of Pharmaceutical Innovation : Volume 8
Journal of Pharmaceutical Innovation : Volume 7
Journal of Pharmaceutical Innovation : Volume 6
Journal of Pharmaceutical Innovation : Volume 5
Journal of Pharmaceutical Innovation : Volume 4
Journal of Pharmaceutical Innovation : Volume 3
Journal of Pharmaceutical Innovation : Volume 3, Issue 4, December 2008
Journal of Pharmaceutical Innovation : Volume 3, Issue 3, September 2008
Journal of Pharmaceutical Innovation : Volume 3, Issue 2, June 2008
Editorial
PQLI Key Topics - Criticality, Design Space, and Control Strategy
PQLI Definition of Criticality
PQLI Design Space
PQLI Engineering Controls and Automation Strategy
PQLI Control Strategy Model and Concepts
The Use of Routine Process Capability for the Determination of Process Parameter Criticality in Small-molecule API Synthesis
Monitoring of High-shear Granulation using Acoustic Emission: Predicting Granule Properties
The Influence of Humidity, Hydrogen Peroxide Concentration, and Condensation on the Inactivation of Geobacillus stearothermophilus Spores with Hydrogen Peroxide Vapor
Real-time Acoustic Elastic Property Monitoring of Compacts During Compaction
Journal of Pharmaceutical Innovation : Volume 3, Issue 1, March 2008
Journal of Pharmaceutical Innovation : Volume 2
Journal of Pharmaceutical Innovation : Volume 1

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PQLI Design Space

Content Provider Springer Nature Link
Author Lepore, John Spavins, James
Copyright Year 2008
Abstract This paper describes progress made by the Design Space Task Team within the ISPE Product Quality Lifecycle Implementation (PQLI) initiative. It is intended to provide approaches to the rational development of Design Space, as well as background on Design Space, its historical origins and how it fits within the wider PQLI initiative. The focus of this paper is on the technical elements of Design Space development.
Starting Page 79
Ending Page 87
Page Count 9
File Format PDF
ISSN 18725120
Journal Journal of Pharmaceutical Innovation
Volume Number 3
Issue Number 2
e-ISSN 19398042
Language English
Publisher Springer US
Publisher Date 2008-05-18
Publisher Place Boston
Access Restriction One Nation One Subscription (ONOS)
Subject Keyword PQLI Design space Criticality Control strategy Critical quality attribute Critical process parameter Knowledge space PAT Pharmaceutical target product profile Product and process knowledge Quality by design Quality risk management Biochemical Engineering Biotechnology Industrial and Production Engineering Pharmacology/Toxicology
Content Type Text
Resource Type Article
Subject Drug Discovery Pharmaceutical Science
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