Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release-Reference-Cited by-同舟云学术

Process analytical technology case study: Part II. Development and validation of quantitative near-infrared calibrations in support of a process analytical technology application for real-time release

Published:2005-06 Issue:2 Volume:6 Page:E273-E283
ISSN:1530-9932
Container-title:AAPS PharmSciTech
language:en
Short-container-title:AAPS PharmSciTech

Author:

Cogdill Robert P.,Anderson Carl A.,Delgado Miriam,Chisholm Robert,Bolton Raymond,Herkert Thorsten,Afnan Ali M.,Drennen James K.

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmaceutical Science,Agronomy and Crop Science,Ecology,Aquatic Science,General Medicine,Ecology, Evolution, Behavior and Systematics

Link

http://link.springer.com/content/pdf/10.1208/pt060238.pdf

Reference25 articles.

1. US Food and Drug Administration. PAT: A Framework for Innovative Manufacturing and Quality Assurance, Guidance for Industry. US Food and Drug Administration, Washington, DC: 2003.

2. US Food and Drug Administration. Guidance Documents: Website of FDA Guidances. US Food and Drug Administration: 2004.

3. Box GEP, Jenkins GM, Reinsel GC.Time Series Analysis. Upper Saddle River, NJ: Prentice Hall; 1994.

4. Jackson JE, Mudholkar GS. Control procedures for residuals associated with principal components analysis.Technometrics. 1979;21:341–349.

5. Martens H, Naes T.Multivariate Calibration. New York, NY: John Wiley and Sons; 1989.

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