Results 141 to 150 of about 299 (155)

A Structured Strategy for Pharmaceutical Analytical Method Development Based on Quality by Design (Qbd) and Analytical Quality by Design (Aqbd): Core Principles, Methodological Tools, and Regulatory Compliance Considerations

International Journal of Drug Delivery Technology
Quality by Design (QbD) represents a systematic, science- and risk-based framework for pharmaceutical development that focuses on proactively embedding quality into products rather than relying exclusively on end-product testing. This approach involves the establishment of a Quality Target Product Profile (QTPP), followed by the identification of ...
Rihana Syed, Rishi Kumar, Venkata Rao Vutla   +2 more
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
, Pavitra Solanki, V Sundaresan
exaly  

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, Sérgio Fujimori, Thamara Mendes, Rayza Almeida, Flávia Sousa, Camila Oliveira, Diogo Nascimento, Felipe R. Lourenco, Maria Isabel Rodrigues, Livia Deris Prado   +9 more
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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

Development and optimization of a stability-indicating chromatographic method for verapamil hydrochloride and its impurities in tablets using an analytical quality by design (AQbD) approach

Microchemical Journal, 2020
Felipe Rebello Lourenço
exaly  

DoE‐assisted development and validation of a stability‐indicating HPLC‐DAD method for simultaneous determination of five cannabinoids in Cannabis sativa L. based on analytical quality by design (AQbD) concept

Phytochemical Analysis, 2022
Maira Ribeiro De Souza, Amelia Henriques, Renata Limberger   +2 more
exaly  

Exploring Analytical Quality by Design (AQbD) Enabled RP-HPLC Method for Carvedilol

Indian Journal of Pharmaceutical Education and Research
Krantisinha Hanumant Randive, Meenaxi Maruti Maste, Amolkumar Ashok Kempwade   +2 more
openaire   +1 more source

Implementation of Analytical Quality by Design (AQbD) in Analytical Method Development and Validation: Current Trends and Regulatory Perspectives Under ICH Q14 and ICH Q2(R2)

Analytical Quality by Design (AQbD) has evolved as a contemporary, science- and risk-based method to developing and validating analytical techniques in the pharmaceutical industry. This review seeks to offer a full overview of AQbD principles and their application to the recently adopted ICH Q14 and ICH Q2(R2) guidelines.
openaire   +1 more source

Development and Optimization of Liquid Chromatography Analytical Methods by Using AQbD Principles: Overview and Recent Advances

Organic Process Research and Development, 2019
Nina Žigart, Zdenko Cäsar
exaly  

Factorial Design Assisted Rp-Hplc Method for Sımultaneous Estimatıon of Luliconazole and Salicylic Acid: Analytical Quality by Design (AQbD) Approach in Method Development

2023
Surabhi Khatake, Abhay Shirode
openaire   +1 more source