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use of outdated development and manufacturing technologies.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

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical
processes following a Quality by Design (QbD) approach, there have been many …

The pharmaceutical industry is under growing pressure to increase efficiency, both in
production and in process development. This paper discusses the central role of Process …

The introduction of the Quality-by-Design (QbD) initiative and of the Process Analytical
Technology (PAT) framework by the Food and Drug Administration has opened the route to …

As the pharmaceutical industry increasingly adopts the Pharma 4.0. concept, there is a
growing need to effectively predict the product quality based on manufacturing or in-process …

The pharmaceutical industry currently faces economic and regulatory challenges associated
with process development. Process modeling tools can play a role in developing robust and …

The pharmaceutical industry is strictly regulated, where precise and accurate control of the
end product quality is necessary to ensure the effectiveness of the drug products. For such …

The purpose of this paper is to provide a summary of the current state of the application of
process systems engineering tools in the pharmaceutical industry. In this paper, we present …

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 …

This paper provides an overview of concepts and computational approaches for the
evaluation of feasibility/flexibility and how they can be used for process design and process …