A review on the modernization of pharmaceutical development and manufacturing–Trends, perspectives, and the role of mathematical modeling
Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …
use of outdated development and manufacturing technologies. The return on investment on …
Modeling in the quality by design environment: Regulatory requirements and recommendations for design space and control strategy appointment
J Djuris, Z Djuric - International journal of pharmaceutics, 2017 - Elsevier
Mathematical models can be used as an integral part of the quality by design (QbD) concept
throughout the product lifecycle for variety of purposes, including appointment of the design …
throughout the product lifecycle for variety of purposes, including appointment of the design …
Introduction to quality by design (QbD): fundamentals, principles, and applications
Pharmaceutical quality has been under long debate for decades. In the current scenario of
regulatory environments, the pharmaceutical industry is continuously facing challenges with …
regulatory environments, the pharmaceutical industry is continuously facing challenges with …
[PDF][PDF] Implications and opportunities of applying QbD principles to analytical measurements
M Schweitzer, M Pohl, M Hanna-Brown… - Pharmaceutical …, 2010 - researchgate.net
The merits of applying quality by design (QbD) to pharmaceutical products and processes is
a topic of significant mutual interest to both pharmaceutical manufacturers and regulatory …
a topic of significant mutual interest to both pharmaceutical manufacturers and regulatory …
A perspective on Quality-by-Control (QbC) in pharmaceutical continuous manufacturing
Abstract The Quality-by-Design (QbD) guidance issued by the US Food and Drug
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …
Quality by design (QbD) approaches in current pharmaceutical set-up
ABSTRACT Introduction: Quality by design (QbD) encourages the pharmaceutical industry
to use risk management and science-based manufacturing principles to gain process and …
to use risk management and science-based manufacturing principles to gain process and …
Model predictive control in pharmaceutical continuous manufacturing: A review from a user's perspective
M Jelsch, Y Roggo, P Kleinebudde… - European Journal of …, 2021 - Elsevier
Pharmaceutical continuous manufacturing is considered as an emerging technology by the
regulatory agencies, which have defined a framework guided by an effective quality risk …
regulatory agencies, which have defined a framework guided by an effective quality risk …
Quality by design in pharmaceutical manufacturing: A systematic review of current status, challenges and future perspectives
Abstract Quality by Design (QbD) was originated in the broad domain of Quality
Management and was recently adapted and formalized in specific terms for assisting …
Management and was recently adapted and formalized in specific terms for assisting …
Multivariate analysis in the pharmaceutical industry: enabling process understanding and improvement in the PAT and QbD era
AP Ferreira, M Tobyn - Pharmaceutical development and …, 2015 - Taylor & Francis
In the pharmaceutical industry, chemometrics is rapidly establishing itself as a tool that can
be used at every step of product development and beyond: from early development to …
be used at every step of product development and beyond: from early development to …
Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality
TF O'Connor, XY Lawrence, SL Lee - International journal of pharmaceutics, 2016 - Elsevier
Issues in product quality have produced recalls and caused drug shortages in United States
(US) in the past few years. These quality issues were often due to outdated manufacturing …
(US) in the past few years. These quality issues were often due to outdated manufacturing …