Results 21 to 30 of about 62,558,702 (211)

Implementing greening into design in analytical chemistry

open access: yesTalanta Open, 2022
From the pharmaceutical industry is known the approach Quality-by-Design (QbD) and this has great influence on analytical methods and procedures it employs.
Jelena Jurjeva, Mihkel Koel
doaj   +1 more source

Quality by Design Approach Using Multiple Linear and Logistic Regression Modeling Enables Microemulsion Scale Up

open access: yesMolecules, 2019
The development of pharmaceutical nanoformulations has accelerated over the past decade. However, the nano-sized drug carriers continue to meet substantial regulatory and clinical translation challenges.
Michele Herneisey   +5 more
doaj   +1 more source

Feasibility and acceptability of a structured quality by design approach to enhancing the rigor of clinical studies at an academic health center

open access: yesJournal of Clinical and Translational Science, 2021
Introduction: Clinical trials are a critical step in the meaningful translation of biomedical discoveries into effective diagnostic and therapeutic interventions.
Hamid Moradi   +3 more
doaj   +1 more source

Implementation of Quality by Design (QbD) for development of bilayer tablets

open access: yesEuropean Journal of Pharmaceutical Sciences, 2023
Bilayer tablets offer various drug release profiles for individual drugs incorporated in each layer of a bilayer tablet, which is rarely achievable by conventional tablets. These tablets also help avoid physicochemical incompatibilities between drugs and excipients.
J. Simão, S.A. Chaudhary, A.J. Ribeiro
openaire   +2 more sources

QUALITY BY DESIGN (QbD) on CLINICAL TRIALS ACTIVITIES – A REVIEW

open access: yes, 2023
Pharmaceutical industry is constantly looking for ways to ensure and enhance product safety, quality and efficacy. However, drug recalls, manufacturing failure costs, scale up issues and regulatory burden in recent past suggest otherwise.
Mr. V. S. Chandrasekaran, Miss. Syed Arshiya Sultana*, Dr. M. Kishore Babu
core   +1 more source

Control Strategy for Excipient Variability in the Quality by Design Approach Using Statistical Analysis and Predictive Model: Effect of Microcrystalline Cellulose Variability on Design Space

open access: yesPharmaceutics, 2022
Although various quality by design (QbD) approaches have been used to establish a design space to obtain robust drug formulation and process parameters, the effect of excipient variability on the design space and drug product quality is unclear.
Ji Yeon Kim, Du Hyung Choi
doaj   +1 more source

Analytical Quality by Design Approach to Test Method Development and Validation in Drug Substance Manufacturing

open access: yesJournal of Chemistry, 2015
Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD (Quality by Design) and PAT
N. V. V. S. S. Raman   +2 more
doaj   +1 more source

Review on Pharmaceutical Quality by Design (QbD)

open access: yesAsian Journal of Pharmaceutical Research and Development, 2019
Pharmaceutical Quality by Design (QBD) is a systematic approach to development that begins with predetermined objectives and emphasizes the understanding of production and processes and process control, based on sound science and quality risk management. Quality purchasing design (QBD) is emerging to increase the promise of providing safe and effective
Mukesh Sharma   +4 more
openaire   +2 more sources

A review on quality by design (QbD) - Its significance and applications [PDF]

open access: yes, 2022
The pharmaceutical Quality by Design (QbD) is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.
Gangaraj Tejaswini; Marri Laxman Reddy Institute of Pharmacy, Dundigal, Hyderabad, Telangana, India
core  

Quality By Design: A Review

open access: yes, 2022
Quality by Design is the most recent quality-related trend in pharmaceutical manufacturing (QbD). This paper discusses Pharmaceutical Quality by Design (QbD) as a way to guarantee high-quality pharmaceuticals. Details about Quality by Design are given in
Devi, K., Savitha, S
core   +1 more source

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