Pharmaceutical Validation Articles from NIR news

Volume 17 Issue 5 Pages 10–14 (2006)

doi: 10.1255/nirn.905

Implementation of near infrared and Raman spectroscopy for tablet composition and relative density analysis for a four-component system

Steven M. Short, Robert P. Cogdill and Carl A. Anderson
Duquesne University, Duquesne Center for Pharmaceutical Technology, 600 Forbes Ave, Pittsburgh, PA 15282, USA

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Volume 17 Issue 2 Pages 4–6 (2006)

doi: 10.1255/nirn.878

A theoretical framework for real time release with NIR and chemometrics

Erik Skibsted,^a,b Johan Westerhuis,^a Age Smilde^a,c and D.T. Witte^d
^aCMC Development, Novo Nordisk A/S, DK-2760 Maaloev, Denmark. E-mail: ersk@novonordisk.com
^bBiosystems Data Analysis, Faculty of Science, University of Amsterdam, Nieuwe Achtergracht 166, 1018 WV, The Netherlands
^cTNO Quality of Life, Utrechtseweg 48, 3700 AJ Zeist, The Netherlands
^dQA/ALC-A, N.V. Organon, Molenstraat 10, PO Box 20, 5340 BH Oss, The Netherlands

Full-text article (143 kB) | Abstract | Buy article on-line

Volume 16 Issue 7 Pages 23–26 (2005)

doi: 10.1255/nirn.858

Near infrared spectroscopy in the pharmaceutical industry

Robert P. Cogdill and James K. Drennen, III
Duquesne University, Center for Pharmaceutical Technology, Pittsburgh, PA, USA

Full-text article (57 kB) | Abstract | Buy article on-line

Volume 16 Issue 5 Pages 15–15 (2005)

doi: 10.1255/nirn.839

Current thoughts on the PAT initiative.

James K. Drennen, III
Duquesne University Center for Pharmeceutical technology, Pittsburgh, PA 15282, USA

Full-text article (80 kB) | Abstract | Buy article on-line

Volume 16 Issue 4 Pages 6–15 (2005)

doi: 10.1255/nirn.826

A prevention based strategy for quality control using PAT

Philip Lunney^a,b and James K. Drennen, III
^aDuquesne University, Center for Pharmaceutical Technology, Pittsburgh, PA, USA

Full-text article (320 kB) | Abstract | Buy article on-line

Volume 16 Issue 3 Pages 7–8 (2005)

doi: 10.1255/nirn.817

Statistical experimental design for PAT method development

Carl A. Anderson, Robert P. Cogdill and James K. Drennen, III
Duquesne University Center for Pharmaceutical Technology, Pittsburgh, PA, Duquesne University, USA

Full-text article (142 kB) | Abstract | Buy article on-line

Volume 16 Issue 2 Pages 14–15 (2005)

doi: 10.1255/nirn.813

Efficient NIR calibrations utilising pure component projection.

Carl A. Anderson and Robert P. Cogdill
Duquesne University Center for Pharmaceutical Technology, Pittsburgh, PA,, USA

Full-text article (57 kB) | Abstract | Buy article on-line

Volume 15 Issue 6 Pages 13–15 (2004)

doi: 10.1255/nirn.796

Calibration transfer in pharmaceutical near infrared spectroscopy

Mark R. Smith
Centre for Pharmaceutical Analysis, The School of Pharmacy, University of London, 29/39 Brunswick Square, London WC1N 1AX, UK

Full-text article (311 kB) | Abstract | Buy article on-line

Volume 15 Issue 5 Pages 12–13 (2004)

doi: 10.1255/nirn.787

Risk analysis for near infrared method development.

Robert P. Cogdill, Carl A. Anderson and James K. Drennen, III
Duquesne University Center for Pharmaceutical Technology, Pittsburgh, PA 15282, USA

Full-text article (53 kB) | Abstract | Buy article on-line

Volume 15 Issue 4 Pages 9–10 (2004)

doi: 10.1255/nirn.777

Critical concerns for implementing Process Analytical Technologies in the pharmaceutical industry

James K. Drennen, Carl A. Anderson and Robert P. Cogdill
Duquesne University Center for Pharmaceutical Technology, Pittsburgh, PA 15282, USA, E-mail: drennen@duq.edu

Full-text article (44 kB) | Abstract | Buy article on-line

Volume 15 Issue 3 Pages 8–9 (2004)

doi: 10.1255/nirn.767

The dissolution profile of USP non- disintegrating calibrator tablets using near infrared spectroscopy

Randall J. Voytilla andJames K. Drennen
Duquesne University Center for Pharceutical Technology, Pittsburgh, PA 15282, USA, E-mail: drennen@duq.edu

Full-text article (370 kB) | Abstract | Buy article on-line

Volume 15 Issue 2 Pages 9–11 (2004)

doi: 10.1255/nirn.758

PAT methods provide process understanding

Arwa S. El-Hagrasy and James K. Drennen
Duquesne University Center for Pharmaceutical Technology, Pittsburgh, PA 15282, USA. E- mail: drennen@duq.edu

Full-text article (910 kB) | Abstract | Buy article on-line

Volume 15 Issue 1 Pages 16–16 (2004)

doi: 10.1255/nirn.754

New ASTM Activity on Pharmaceutical Application of Process Analytical Technology

Jim Drennen
Duquesne University Center for Pharceutical Technology, Pittsburgh, PA 15282, USA, E- mail: drennen@duq.edu

Full-text article (347 kB) | Abstract | Buy article on-line

Volume 14 Issue 6 Pages 7–8 (2003)

doi: 10.1255/nirn.741

Pharmaceutical Validation. Near infrared spectroscopy for determining the hardness of roller compacted briquettes

Vishal Bijlani, Carl Anderson, Christianah Adeyeye and Jim Drennen
Duquesne University Center for Pharceutical Technology, Pittsburgh, PA 15282, USA, E-mail: drennen@duq.edu

Full-text article (1571 kB) | Abstract | Buy article on-line

Volume 14 Issue 5 Pages 14–15 (2003)

doi: 10.1255/nirn.736

Pharmaceutical Validation. Calibration transfer: a critical component of analytical method validation

Jim Drennen
Duquesne University Center for Pharceutical Technology, Pittsburgh, PA 15282, USA, E-mail: drennen@duq.edu

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Volume 14 Issue 4 Pages 14–15 (2003)

doi: 10.1255/nirn.728

Pharmaceutical Validation. PASG NIR Sub-Group update

Neville Broad
Chairman, Pharmaceutical Analytical Sciences Group, NIR Sub-Group

Full-text article (1862 kB) | Abstract | Buy article on-line

Volume 14 Issue 3 Pages 14–15 (2003)

doi: 10.1255/nirn.720

Comparability protocols: chemistry, manufacturing and controls information

Jim Drennen and Carl Andersen
Center for Pharmaceutical Technology, Duquesne University, USA

Full-text article (1956 kB) | Abstract | Buy article on-line

Volume 14 Issue 2 Pages 22–24 (2003)

doi: 10.1255/nirn.711

In situ spectroscopic cleaning validation

Aaron A. Urbas and Robert A. Lodder
College of Pharmacy and Department of Chemistry, University of Kentucky, Lexington, KY 40536-0082, USA. E-mail: lodder@uky.edu

Full-text article (2931 kB) | Abstract | Buy article on-line

Volume 13 Issue 5 Pages 8–14 (2002)

doi: 10.1255/nirn.680

Pharmaceutical Validation. Near infrared spectroscopy for monitoring the hardness of roller compacted ribbons

Vishal J. Bijlani, Miriam Delgado-Lopez, Christianah Moji Adeyeye and James K. Drennen III
Graduate School of Pharmaceutical Sciences, Duquesne University, Pittsburgh, PA 15282, USA

Full-text article (552 kB) | Abstract | Buy article on-line

Volume 13 Issue 4 Pages 8–9 (2002)

doi: 10.1255/nirn.669

Pharmaceutical Validation. Non- destructive tablet hardness testing: the effect of moisture on tablet hardness prediction

James K. Drennen and Randall J. Voytilla
Duquesne University, Graduate School of Pharmaceutical Sciences, Pittsburgh, PA 15282, USA. E-mail: drennen@duq.edu

Full-text article (127 kB) | Abstract | Buy article on-line

Volume 13 Issue 3 Pages 12–14 (2002)

doi: 10.1255/nirn.665

Pharmaceutical Validation. The FDA is coming!! The FDA is coming!!

Howard Mark
Mark Electronics, 21 Terrace Avenue, Suffern, NY 10901, USA.

Full-text article (80 kB) | Abstract | Buy article on-line

Volume 13 Issue 2 Pages 14–14 (2002)

doi: 10.1255/nirn.659

Pharmaceutical Validation. Process analytical technologies

James K. Drennen III
Associate Professor of Pharmaceutics and Head, Pharamaceutical Sciences Division, School of Pharmacy, Duquesne University, Pittsburgh, PA 15282, USA. E-mail: drennen@duq.edu

Full-text article (998 kB) | Abstract | Buy article on-line

Volume 13 Issue 1 Pages 12–13 (2002)

doi: 10.1255/nirn.648

Pharmaceutical NIR spectroscopy: a state of enthusiastic anticipation

Gary E. Ritchie
Chairman, NIRVWoG, (Near Infrared Validation Working Group) Purdue Pharma L.P. (IR&D), Ardsley, NY 10502, USA. E-mail: Gary.Ritchie@Pharma.com

Full-text article (332 kB) | Abstract | Buy article on-line

Volume 12 Issue 6 Pages 10–13 (2001)

doi: 10.1255/nirn.640

Pharmaceutical Validation. Proving the specificity of your NIR method

James K. Drennen III, Associate Professor of Pharmaceutics and Head
Pharmaceutical Sciences Division, School of Pharmacy, Duquesne University, Pittsburgh, PA 15282, USA. E-mail: drennen@duq.edu

Full-text article (289 kB) | Abstract | Buy article on-line

Volume 12 Issue 5 Pages 13–13 (2001)

doi: 10.1255/nirn.632

Pharmaceutical Validation. Proposed <1119> Revision

James K. Drennen III, Associated Professor of Pharmaceuticals and Head
Pharmaceutical Sciences Division, Duquesne University, Pittsburgh, PA 15282, USA. E-mail: drennen@duq.edu

Full-text article (857 kB) | Abstract | Buy article on-line

Volume 12 Issue 4 Pages 7–13 (2001)

doi: 10.1255/nirn.623

Pharmaceutical Validation. The PASG validation guidelines for NIR methods in the pharmaceutical industry

Ken Prebble
Pharmaceutical Analytical Sciences Group, NIR Sub-Group, UK

Full-text article (2780 kB) | Abstract | Buy article on-line

Volume 12 Issue 2 Pages 5–6 (2001)

doi: 10.1255/nirn.604

Pharmaceutical Validation Column

James K. Drennen III, Associate Professor of Pharmaceutics and Head
Pharmaceutical Sciences Division, School of Pharmacy, Duquesne University, Pittsburgh, PA 15282, USA. E-mail: drennen@duq.edu

Full-text article (1807 kB) | Abstract | Buy article on-line