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Life cycle management of analytical methods

Published:2018-01 Issue: Volume:147 Page:506-517
ISSN:0731-7085
Container-title:Journal of Pharmaceutical and Biomedical Analysis
language:en
Short-container-title:Journal of Pharmaceutical and Biomedical Analysis

Author:

Parr Maria Kristina,Schmidt Alexander H.

Publisher

Elsevier BV

Subject

Clinical Biochemistry,Spectroscopy,Drug Discovery,Pharmaceutical Science,Analytical Chemistry

Reference209 articles.

1. The reliability parameter and its importance for life cycle management;Baglow;Microelectron. Reliab.,1975

2. Quality by design: a lifecycle concept for pharmaceutical analysis;Ermer;Eur. Pharm. Rev.,2011

3. Life cycle and quality by design for chromatographic methods;McDowall;LCGC Europe,2014

4. Stimuli to the revision process: fitness for use: decision rules and target measurement uncertainty;Burgess;Pharm. Forum,2016

5. Stimuli to the revision process: analytical control strategy;Kovacs;Pharm. Forum,2016

Cited by 83 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Application of Analytical Quality by Design to the development and validation of reduced and non-reduced capillary electrophoresis analytical procedures for mAb purity determination;Journal of Pharmaceutical and Biomedical Analysis;2024-10

2. Analytical QbD for the optimization of a multimode HPLC method for the investigation of hydrochlorothiazide, diltiazem and propranolol release from 3D printed formulation;Journal of Pharmaceutical and Biomedical Analysis;2024-09

3. Analytical Quality by Design as applied to the development of a SEC-HPLC platform procedure for the determination of monoclonal antibody purity without mobile phase additives;Journal of Pharmaceutical and Biomedical Analysis;2024-08

4. A case study application of AQbD to the re-development and validation of an affinity chromatography analytical procedure for mAb titer quantitation;Journal of Chromatography B;2024-07

5. Stability-Indicating UPLC-PDA-QDa Methodology for Carvedilol and Felodipine in Fixed-Dose Combinations Using AQbD Principles;Scientia Pharmaceutica;2024-04-25

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