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Application of analytical quality by design (AQbD) for stability-indicating method development for quantification of nevirapine and its degradation products

Microchemical Journal, 2023
Ivone Lopes   +9 more
openaire   +2 more sources

A Mini Overview of Analytical Quality by Design (AQbD)

A methodical, science- and risk-based approach to pharmaceutical development, Quality by  Design (QbD) emphasizes incorporating quality into goods rather than depending just on end product testing. Through standards like ICH Q8 (Pharmaceutical Development), Q9 (Quality Risk  Management), and Q10 (Pharmaceutical Quality System), regulatory bodies ...
openaire   +1 more source

ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH FOR LIFECYCLE MANAGEMENT OF PHARMACEUTICAL ANALYTICAL METHODS

The pharmaceutical industry has increasingly adopted science- and risk-based approaches to ensure the quality, safety, and efficacy of pharmaceutical products. One of the most widely implemented strategies is Quality by Design (QbD), which emphasises systematic product and process understanding during drug development.
openaire   +1 more source

Eco‐Friendly RP‐HPLC Method for Simultaneous Estimation of Amlodipine Besylate and Indapamide: Analytical Quality by Design Approach and Greenness Assessment

Separation Science Plus
This study presents the development and validation of an RP‐HPLC method for simultaneously estimating amlodipine besylate and indapamide using an Analytical Quality by Design (AQbD) approach.
Vibhuti A. Rabadiya   +2 more
semanticscholar   +1 more source

Enhancing Pharmaceutical Analysis with Analytical Quality by Design in UHPLC: A Review of Methodological Innovations (2014-2025).

Critical reviews in analytical chemistry
The integration of analytical quality by design (AQbD) in ultrahigh-performance liquid chromatography (UHPLC) has enhanced pharmaceutical method development by improving robustness, efficiency, and regulatory compliance.
R. Kotadiya
semanticscholar   +1 more source

Analytical quality by design and measurement uncertainty in the development of discriminative dissolution method for pediatric fixed-dose combination dispersible tablets of isoniazid and rifampicin.

Journal of Pharmaceutical and Biomedical Analysis
Analytical Quality by Design (AQbD) is a proactive approach that ensures the consistent performance of analytical methods throughout the lifecycle. The application of AQbD in dissolution testing remains limited, particularly with the incorporation of ...
M. S. dos Santos   +5 more
semanticscholar   +1 more source

ANALYTICAL QUALITY BY DESIGN (AQBD) APPROACH IN UV SPECTROSCOPIC METHOD DEVELOPMENT: CURRENT TRENDS AND APPLICATIONS

Analytical Quality by Design (AQbD) has become a structured, scientific and risk-based methodology of creating reliable and robust methodologies of analysis within the pharmaceutical industry. As opposed to traditional trial and error methods, AQbD combines preconceived goals, risk analysis tools and statistical optimization methods to provide ...
openaire   +1 more source

Analytical quality-by-design (AQbD) guided development of a robust HPLC method for the quantification of plumbagin from Plumbago species

Journal of Liquid Chromatography and Related Technologies, 2021
Ritu Tiwari   +2 more
exaly  

Method Development Based on an Analytical Quality by Design (AQBD) Approach

Tese de Doutoramento em Ciências Farmacêuticas apresentada à Faculdade de ...
openaire   +1 more source

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