Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure-Reference-Cited by-同舟云学术

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Analytical Procedure Development and Proposed Established Conditions: A Case Study of a Mass Spectrometry Based NDSRI Analytical Procedure

Published:2024-08 Issue: Volume: Page:
ISSN:0022-3549
Container-title:Journal of Pharmaceutical Sciences
language:en
Short-container-title:Journal of Pharmaceutical Sciences

Author:

Zhang Jinhui,Raghavachari Ramesh,Kirkpatrick Douglas C.^ORCID,Keire David A.^ORCID,Xu Xiaoming^ORCID,Faustino Patrick J.

Funder

U.S. Food and Drug Administration

Publisher

Elsevier BV

Reference19 articles.

1. ICH 2019. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Q12.

2. ICH 2023. https://database.ich.org/sites/default/files/ICH_Q14_Guideline_2023_1116.pdf. Analytical Procedure Development Q14.

3. Analytical quality by design, life cycle management, and method control;Verch;AAPS J,2022

4. Established Conditions for Analytical Procedures and QbD;Jean-François Dierick,2023

5. ICH Q2(R2) & Q14 Aim to Promote More Robust Analytical Processes, Greater Ease for Switching Analytical Methods Post Approval;Castle,2022

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