A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error

Harry Yang; Jianchun Zhang

doi:10.5731/pdajpst.2015.01081

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A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error

Harry Yang and Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology November 2015, 69 (6) 725-735; DOI: https://doi.org/10.5731/pdajpst.2015.01081

Harry Yang

MedImmune, LLC

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For correspondence: yangh@medimmune.com

Jianchun Zhang

MedImmune, LLC

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vol. 69 no. 6 725-735

DOI

https://doi.org/10.5731/pdajpst.2015.01081

PubMed

26659103

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online December 10, 2015.

Author Information

Harry Yang* and
Jianchun Zhang

MedImmune, LLC

↵*Corresponding Athor: Harry Yang, yangh{at}medimmune.com

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A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error

Harry Yang, Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 725-735; DOI: 10.5731/pdajpst.2015.01081

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A Generalized Pivotal Quantity Approach to Analytical Method Validation Based on Total Error

Harry Yang, Jianchun Zhang

PDA Journal of Pharmaceutical Science and Technology Nov 2015, 69 (6) 725-735; DOI: 10.5731/pdajpst.2015.01081

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Keywords

Consumer's risk
generalized pivotal quantity
Method validation
Tolerance interval
Total error
Type I error

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