Results 71 to 80 of about 329 (162)

A Mini Overview of Analytical Quality by Design (AQbD)

open access: yes
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

Systematic AQbD Approach to UPLC Method Development for Elacestrant and Pirtobrutinib

open access: yes
The evolution of pharmaceutical analysis has led to the integration of Analytical Quality by Design (AQbD). This strategic framework enhances the robustness, reliability, and regulatory compliance of analytical methods. This review focuses on the AQbD-based development and validation of a novel Ultra Performance Liquid Chromatography (UPLC) method for ...
openaire   +1 more source

Quality by design in public healthcare: a rapid development framework for future pandemics

open access: yesJournal of Pharmacy & Pharmaceutical Sciences
The growing number of pandemics and emergencies traversing the world in recent decades has illustrated the vulnerability of the conventional pharmaceutical development process and the necessity of an efficient, robust, and patient-driven pandemic-ready ...
Niranjan Panda   +5 more
doaj   +1 more source

AQbD guided optimization and validation of RP-HPLC method for Vildagliptin

open access: yes
Vildagliptin is an anti-diabetic drug used primarily for type 2 diabetes mellitus. One of themain reasons quality is lost in pharmaceuticals is the absence of appropriate and valid analyticaltechniques. This paper aims to describe the development and verification of a Quality byDesign (QbD) RP-HPLC method to determine Vildagliptin in bulk and tablet ...
openaire   +1 more source

Analytical Quality by Design (AQbD): Principles, Tools and Case Studies

open access: yes
Quality by Design is a systematic approach used in pharmaceutical development that builds product quality into the formulation and manufacturing processes from the outset. Although its adoption is increasing within the generic drug industry, many professionals are still not deeply familiar with its principles or terminology.
openaire   +1 more source

A comprehensive RP-HPLC technique for analyzing disodium edetate and its degradation products in eye drops using AQbD and Six Sigma perspective

open access: yesReviews in Analytical Chemistry
The study presents the development of a novel, sustainable, and analytical quality by design (AQbD) driven RP-HPLC method to simultaneously identify disodium edetate in eye drops and its degradation products.
Alanazi Tahani Y. A.   +5 more
doaj   +1 more source

Integrated Application of Risk Management Techniques in Developing an Analysis Method for Traditional Chinese Medicine: A Case Study of a Percolation Solution for Xiaochaihu Capsules

open access: yesChemosensors
Risk management should run through the entire process of method development, utilization, and maintenance. Based on the analytical quality by design (AQbD) concept, various integrated risk management techniques were used in this study to develop an ...
Mintong Zhao   +5 more
doaj   +1 more source

RP-HPLC method development and validation of Abacavir, Lamivudine and Zidovudine in combined pharmaceutical dosage by analytical QbD

open access: yesDiscover Chemistry
An accurate, precise, robust, and green RP-HPLC method was developed for assessment of three antiviral medications, namely Abacavir (ABA), Lamivudine (LAMI), and Zidovudine (ZIDO) in combined pharmaceutical dosage form by Analytical Quality by Design ...
Divyesh Vanparia   +2 more
doaj   +1 more source

Implementation of quality by design and green chemistry principles to validate the stability indicating method on UHPLC for the simultaneous quantification of Glycopyrronium, Fluticasone, Vilanterol in inhaled formulation

open access: yesGreen Analytical Chemistry
The combination of Glycopyrronium, Fluticasone, and Vilanterol is utilized to manage chronic obstructive pulmonary disease (COPD) and mitigate asthma symptoms.
Anitha L, Durga Prasad Beda
doaj   +1 more source

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