Recently, the pharmaceutical industry has been facing several challenges associated to the
use of outdated development and manufacturing technologies. The return on investment on …

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 …

Pharmaceutical quality has been under long debate for decades. In the current scenario of
regulatory environments, the pharmaceutical industry is continuously facing challenges with …

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 …

Abstract The Quality-by-Design (QbD) guidance issued by the US Food and Drug
Administration (FDA) has catalyzed the modernization of pharmaceutical manufacturing …

ABSTRACT Introduction: Quality by design (QbD) encourages the pharmaceutical industry
to use risk management and science-based manufacturing principles to gain process and …

Pharmaceutical continuous manufacturing is considered as an emerging technology by the
regulatory agencies, which have defined a framework guided by an effective quality risk …

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 …

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 …

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 These quality issues were often due to outdated manufacturing …