Applications of MVDA and PAT for Drug Product Development and Manufacturing

Author:

Corredor Claudia C.,Bu Dongsheng,McGeorge Gary

Publisher

Elsevier

Reference82 articles.

1. Time-resolved NIR spectroscopy for quantitative analysis of intact pharmaceutical tablets;Abrahamsson;Analytical Chemistry,2005

2. Analysis of low content drug tablets by transmission near infrared spectroscopy: Selection of calibration ranges according to multivariate detection and quantitation limits of PLS models;Alcalà;Journal of Pharmaceutical Sciences,2008

3. E2891-13, standard guide for multivariate data analysis in pharmaceutical development and manufacturing applications;ASTM,2013

4. E2898-14, standard guide for risk-based validation of analytical methods for PAT applications;ASTM,2014

5. Risk analysis of analytical validations by probabilistic modification of FMEA;Barends;Journal of Pharmaceutical and Biomedical Analysis,2012

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