Results 1 to 10 of about 242 (129)

Analytical Quality by Design (AQbD) Approach to the Development of Analytical Procedures for Medicinal Plants [PDF]

Plants, 2022
Scientific regulatory systems with suitable analytical methods for monitoring quality, safety, and efficacy are essential in medicinal plant drug discovery.
Geonha Park, Min Kyoung Kim, Seung Hyeon Go, Minsik Choi, Young Pyo Jang   +4 more
doaj   +4 more sources

Analytical Quality by Design (AQbD) Approach to the Development of In Vitro Release Test for Topical Hydrogel [PDF]

Pharmaceutics, 2022
The aim of our study was to adapt the analytical quality by design (AQbD) approach to design an effective in vitro release test method using USP apparatus IV with a semi-solid adapter (SSA) for diclofenac sodium hydrogel.
Réka Szoleczky, Mária Budai-Szűcs, Erzsébet Csányi, Szilvia Berkó, Péter Tonka-Nagy, Ildikó Csóka, Anita Kovács   +6 more
doaj   +7 more sources

Eco-conscious AQbD-guided stability-indicating RP-UPLC method for analysing Tovorafenib in bulk and dosage forms [PDF]

Scientific Reports
Tovorafenib is a type II RAF inhibitor recently approved by the FDA for relapsed or refractory paediatric low-grade glioma in children aged 6 months and older with BRAF fusions or V600E mutations, owing to its strong central nervous system penetration ...
Vanga Mohan Goud, Sarad Pawar Naik Bukke, Praveen Kumar Kusuma, Satla Shobha Rani, M. Sunitha Reddy, Chandrashekar Thalluri, Bayapa Reddy Narapureddy   +6 more
doaj   +2 more sources

AQbD Approach Applied to NIR in a Complex Topical Formulation: Bifonazole as Case Study [PDF]

Pharmaceutics
Background: A key challenge in modern pharmaceutical research is developing predictive models for drug formulation behavior. Since permeability is closely linked to molecular properties, considering a broad of characteristics is essential for building ...
Lucas Chiarentin, Vera Moura, Alberto A. C. C. Pais, Carla Vitorino   +3 more
doaj   +2 more sources

Definições e escopo dos elementos-chave do Analytical Quality by Design (AQbD) para o desenvolvimento de métodos na indústria farmacêutica

Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia, 2023
Introdução: O setor farmacêutico está em constante evolução e é altamente regulado com normas para garantir eficácia, segurança e qualidade dos medicamentos.
Rosemberg Bernardez Moure, Flávia Furtado de Mendonça de Sousa, Diogo Dibo do Nascimento, Jorge Lima de Magalhães, Camila Areias de Oliveira, Livia Deris Prado   +5 more
doaj   +2 more sources

Systematic Development and Validation of a Thin-Layer Densitometric Bioanalytical Method for Estimation of Mangiferin Employing Analytical Quality by Design (AQbD) Approach. [PDF]

J Chromatogr Sci, 2016
The present work aims at the systematic development of a simple, rapid and highly sensitive densitometry-based thin-layer chromatographic method for the quantification of mangiferin in bioanalytical samples. Initially, the quality target method profile was defined and critical analytical attributes (CAAs) earmarked, namely, retardation factor (Rf ...
Khurana RK, Rao S, Beg S, Katare OP, Singh B.   +4 more
europepmc   +4 more sources

AQbD-driven development of a green RP-HPLC method for nirogacestat with LC–MS structural elucidation [PDF]

BMC Chemistry
Nirogacestat (NGT), a recently approved γ-secretase inhibitor for desmoid tumors, requires sensitive and sustainable analytical methods for impurity profiling.
Jayanthi Sabi, Kanaka Parvathi Kannaiah, Hemanth Kumar Chanduluru, Srinivas Nakka, Samar H. Elagamy, Reem H. Obaydo   +5 more
doaj   +2 more sources

Increasing Analytical Quality by Designing a Thin-Layer Chromatography Scanner Method for the Determination of the Radiochemical Purity of Radiopharmaceutical Sodium Iodide ¹³¹I Oral Solution [PDF]

Molecules
The goal of this study was to apply the principles of analytical quality by design (AQbD) to the analytical method for determining the radiochemical purity (PQR) of the radiopharmaceutical sodium iodide 131I oral solution, utilizing thin-layer ...
Miguel Vasquez-Huaman, Américo Castro-Luna, Norma Julia Ramos-Cevallos, Donald Ramos-Perfecto, Mario Alcarraz-Curi, Jacqueline Segura-Vasquez, Danny Cáceres-Antaurco   +6 more
doaj   +2 more sources

Integrating analytical quality by design into bioanalytical method development: an HPLC-FLD method for quantification of alectinib in biological matrix [PDF]

BMC Chemistry
This study presents the development and validation of a fluorescence-based high-performance liquid chromatography (HPLC) method for the quantification of alectinib in rat plasma, with a focus on the application of Analytical Quality by Design (AQbD) to ...
Eun Ji Lee, Nahyun Koo, Min Ju Kim, Kyeong-Ryoon Lee, Yoon-Jee Chae   +4 more
doaj   +2 more sources

Analytical quality by design (AQbD) assisted RP-HPLC technique for quantification of Picroside II in bulk and pharmaceutical dosage form

Future Journal of Pharmaceutical Sciences
Background Quality by design (QbD) adverts toward gaining of few expected quality with predetermined and desired specifications. Analytical quality by design (AQbD) approach toward the development of analytical method can significantly lead toward the ...
Sharib Raza Khan, Shailesh Dadge, Shivam Rathaur, Jiaur R. Gayen   +3 more
doaj   +3 more sources