Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

By Lawrence X. Yu. Pharmaceutical Research, 2008

1,202 citations recorded by the source corpus.

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

3D printing in pharmaceutics: A new tool for designing customized drug delivery systems. (2016, background): “As a consequence, the complexities of the manufacturing process, particularly for complex dosage forms, are often not recognized [Yu, 2008].”
When Risks Cannot Be Seen: Regulating Uncertainty in Emerging Technologies (2017, neutral): “In an industry with stringent certification procedures like pharmaceuticals, Yu (2008) argues that traditional approaches to quality control may be hindering quality and performance by restraining flexibility in manufacturing process and testing.”
Explicit Residence Time Distribution of a Generalised Cascade of Continuous Stirred Tank Reactors for a Description of Short Recirculation Time (Bypassing) (2019, background): “Better process understanding and control lead ultimately to improved quality of the final product, in a quality-by-design (QdB) framework [3,5,6].”
A Survey on Deep Learning for Data-Driven Soft Sensors (2021, background): “The changes of loads and feedstocks also result in process variations and deteriorate the performance of process modeling, such as in the pharmaceutical industry [35].”
PBPK models for the prediction of in vivo performance of oral dosage forms. (2014, positive): “This study, in which a mechanistic model of formulations is constructed to understand the impact of change is in alignment with the U.S. Food and Drug Administration (FDA) Quality-by-design (QbD) initiative (Yu, 2008).”