A practical approach to estimate analytical method variability from routine testing-Reference-Cited by-同舟云学术

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A practical approach to estimate analytical method variability from routine testing

Published:2024-10 Issue: Volume:249 Page:116344
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Bonifas Andrew P.,Li Yi

Publisher

Elsevier BV

Reference21 articles.

1. USP General Chapter <1220> Analytical Procedure Life Cycle, USP, Rockville, MD, 2022.

2. ICH Guideline Q14 Analytical Procedure Development 2023.

3. Distinguishing the analytical method from the analytical procedure to support the USP analytical procedure life cycle paradigm;Borman;Pharmacop. Forum,2019

4. Ongoing analytical procedure performance verification - stage 3 of USP <1220>, Pharmaceutical;Borman;Technology,2023

5. Using the analytical target profile to drive the analytical method lifecycle;Jackson;Anal. Chem.,2019

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