Using the Analytical Target Profile to Drive the Analytical Method Lifecycle-Reference-Cited by-同舟云学术

Using the Analytical Target Profile to Drive the Analytical Method Lifecycle

Published:2019-01-09 Issue:4 Volume:91 Page:2577-2585
ISSN:0003-2700
Container-title:Analytical Chemistry
language:en
Short-container-title:Anal. Chem.

Author:

Jackson Patrick¹^ORCID,Borman Phil¹,Campa Cristiana²,Chatfield Marion¹,Godfrey Mark³,Hamilton Peter¹,Hoyer Walter⁴,Norelli Francesco²,Orr Rachel¹,Schofield Tim⁵

Affiliation:

1. Product Development and Supply, Medicines Research Centre, GSK, Gunnels Wood Road, Stevenage SG1 2NY, U.K.

2. Technical Research and Development, GSK Vaccines, via Fiorentina 1, 53100 Siena, Italy

3. Product Development and Supply, David Jack Research Centre, GSK, Park Road, Ware SG12 0 DP, U.K.

4. Technical Research and Development, GSK Vaccines, Emil-von-Behring-Straße 76, 35041 Marburg, Germany

5. CMC Sciences, LLC, Germantown, Maryland 20876, United States

Publisher

American Chemical Society (ACS)

Subject

Analytical Chemistry

Link

https://pubs.acs.org/doi/pdf/10.1021/acs.analchem.8b04596

Reference37 articles.

1. European Medicines Agency. Quality by Design. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000162.jsp (accessed December 19, 2018).

2. Six Sigma: Definition and underlying theory⋆

3. ICH Quality Guidelines. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html (accessed December 19, 2018).

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