Risk-based approach for method development in pharmaceutical quality control context: A critical review

R Deidda, S Orlandini, P Hubert, C Hubert - Journal of pharmaceutical and …, 2018 - Elsevier
Pharmaceutical regulatory bodies increasingly require the implementation of systematic
approaches in pharmaceutical product development. Quality control methods play a key role …

Drilling into “Quality by Design” approach for analytical methods

L Chiarentin, C Gonçalves, C Augusto… - Critical Reviews in …, 2024 - Taylor & Francis
The need for consistency in analytical method development reinforces the dependence of
pharmaceutical product development and manufacturing on robust analytical data. The …

Development and optimization of liquid chromatography analytical methods by using AQbD principles: Overview and recent advances

T Tome, N Žigart, Z Časar… - Organic process research …, 2019 - ACS Publications
This review presents the Analytical Quality by Design (AQbD) concept, an extension of
Quality by Design (QbD), which was introduced in 2004 by the US Food and Drug …

Analytical method lifecycle management in pharmaceutical industry: A review

L Volta e Sousa, R Gonçalves, JC Menezes… - Aaps Pharmscitech, 2021 - Springer
The adoption of Quality by Design (QbD) and Analytical Method Lifecycle Management
(AMLM) concepts to ensure the quality of pharmaceutical products has been applied and …

Synthesis and design of purpurin-18-loaded solid lipid nanoparticles for improved anticancer efficiency of photodynamic therapy

S Yeo, HH Song, MJ Kim, S Hong, I Yoon, WK Lee - Pharmaceutics, 2022 - mdpi.com
Purpurin-18 (P18) is one of the essential photosensitizers used in photodynamic therapy
(PDT), but its hydrophobicity causes easy coalescence and poor bioavailability. This study …

Development of a unified reversed-phase HPLC method for efficient determination of EP and USP process-related impurities in celecoxib using analytical quality by …

T Tome, Z Časar, A Obreza - Molecules, 2020 - mdpi.com
This article presents the development of a reversed-phase (RP) high-performance liquid
chromatographic (HPLC) method for determination of process-related impurities in a …

Design of experiment avenue for development and validation of RP-HPLC-PDA method for determination of apremilast in bulk and in in-house tablet formulation

SR Chaudhari, AA Shirkhedkar - Journal of Analytical Science and …, 2019 - Springer
Background Apremilast is phosphodiesterase-4 and an immunomodulating agent used for
treatment of refractory psoriatic arthritis. Methods The reversed-phase high-performance …

Quinquennial review of progress in degradation studies and impurity profiling: an instrumental perspective statistics

M Shelke, SS Deshpande, S Sharma - Critical reviews in analytical …, 2020 - Taylor & Francis
Degradation studies of drug give insightful information about the intrinsic stability of the
molecule, the possible degradents formed during shelf life and thus, aid in the subsequent …

A complete roadmap of analytical quality by design in various analytical techniques

MK Santhanam, NC Nagarajan… - Current …, 2023 - benthamdirect.com
Background: For the development of robust analytical methods, Analytical-Qualityby-Design
(AQbD)-based testing methods have been found to be more suited than other one factorial …

Design and characterisation of pH-responsive photosensitiser-loaded nano-transfersomes for enhanced photodynamic therapy

S Yeo, I Yoon, WK Lee - Pharmaceutics, 2022 - mdpi.com
Photodynamic therapy (PDT) is a non-invasive and tumour-specific therapy.
Photosensitizers (PSs)(essential ingredients in PDT) aggregate easily owing to their …