Results 11 to 20 of about 1,038 (200)

A Practical Approach to Implementing ICH Q14: Tools for Analytical Quality by Design in Capillary Electrophoresis Method Development. [PDF]

Electrophoresis
The ICH Q14 guideline introduces a structured framework for analytical method development based on Analytical Quality by Design (AQbD) principles, aiming to ensure robust, reliable, and fit‐for‐purpose methods throughout the product lifecycle.
Tricht EV, Sänger-van de Griend CE.
europepmc   +3 more sources

An analytical quality by design (aQbD) approach for a l -asparaginase activity method [PDF]

Journal of Pharmaceutical and Biomedical Analysis, 2016
L-asparaginase is an effective anti-tumor agent for acute lymphoblastic leukemia. This work presents the development of an activity determination of L-ASNase preparations for pharmaceutical quality control purposes, in accordance with analytical Quality by Design principles.
Han Yao, Jochem Vancoillie, Matthias D’Hondt, Evelien Wynendaele, Nathalie Bracke, Bart De Spiegeleer   +5 more
openaire   +4 more sources

Development and Validation of an in-line API Quantification Method Using AQbD Principles Based on UV-Vis Spectroscopy to Monitor and Optimise Continuous Hot Melt Extrusion Process [PDF]

Pharmaceutics, 2020
A key principle of developing a new medicine is that quality should be built in, with a thorough understanding of the product and the manufacturing process supported by appropriate process controls. Quality by design principles that have been established
Juan Almeida, Mariana Bezerra, Daniel Markl, Andreas Berghaus, Phil Borman, Walkiria Schlindwein   +5 more
doaj   +4 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

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

Analytical Quality by Design (AQBD) Assisted Development and Validation of HPTLC Method for Estimation of Rottlerin in Topical Patch Formulation

Pharmacognosy Research, 2023
Background: Rottlerin, a natural polyphenolic ketone is a major constituent of Mallotus philippensis (Lam.) Mull. Arg. plant. Although, less explored it has diverse array of therapeutic applications.
Kaumudee Bodas, Vaibhav M Shinde, Deshmukh Vishal, Deshmukh Sheetal   +3 more
openaire   +2 more sources

Analytical Quality by Design (AQbD) for Quality and Risk Assessment of Pharmaceuticals to Immunomarkers

Journal of Pharmaceutical and Biopharmaceutical Research
Using advanced scientific and risk-based approaches for analytical methods offers significant benefits. Quality by Design (QbD) is a systematic framework that emphasizes understanding and controlling both product and process elements. Adhering to the principles outlined in the ICH guidelines can considerably improve the quality of drug substances ...
Vivekanandan Kalaiselvan, Meenakshi Dahiya, Gaurav Sanjay Mahalpure, Ritu Tiwari   +3 more
openaire   +2 more sources

Analytical quality by design (AQbD) methodology for concurrent determination of perindopril erbumine and moxonidine hydrochloride using RP-HPLC with an eco-friendly evaluation

Discover Chemistry
Ashok H. Akabari, Sagar K. Patel, Ketan V. Shah, Arun Patel, Dixitkumar Modi, Ashim Kumar Sen, Vinodkumar D. Ramani, Dhiren P. Shah, Sagarkumar P. Patel   +8 more
semanticscholar   +4 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