[HTML][HTML] Interpretable artificial neural networks for retrospective QbD of pharmaceutical tablet manufacturing based on a pilot-scale developmental dataset

B Nagy, Á Szabados-Nacsa, G Fülöp… - International Journal of …, 2023 - Elsevier
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 …

Artificial intelligence (AI) in drug product designing, development, and manufacturing

S Chaudhary, P Muthudoss, T Madheswaran… - A handbook of artificial …, 2023 - Elsevier
By means of a science and risk-based systematic approach to pharmaceutical product
development through the DoE/QbD system, a control strategy will be defined for each of the …

[HTML][HTML] Quality by design: a suitable methodology in industrial pharmacy for Costa Rican universities

L Castillo-Henríquez, B Murillo-Castillo… - Scientia …, 2022 - mdpi.com
This review aims to present the Quality by Design (QbD) model as a suitable methodology to
perform research in the academic Costa Rican institutions that teach Pharmacy. Pubmed …

QbD application for a fixed-dose combination with biowaiver potential: evaluations of in vitro and in vivo applications

D Sarisaltik-Yasin, A Uslu, E Uyar, M Erdinc… - Journal of …, 2023 - Springer
Purpose The purpose of this study was to use the quality by design (QbD) approach to
design a directly compressed fixed-dose combination (FDC) tablet comprising amlodipine …

Assessment of Manufacturing Related Deficiencies for Modified Release Tablet in Abbreviated New Drug Applications

J Chen, Z Wang, R Shah, A Scherlitz, X Feng… - AAPS …, 2022 - Springer
Generic drugs play an important role in public health. However, the first review cycle
approval rate for Abbreviated New Drug Applications (ANDAs) is generally low. To identify if …

Formulation by design (FbD): an emerging approach to design vesicular nanocarriers

SK Prajapati, P Kesharwani, N Mody… - Micro-and …, 2021 - taylorfrancis.com
Quality is the most crucial attribute for pharmaceutical product development, and it has
become the thrust area for the regulatory bodies to approve safe, efficacious, stable, patient …

Mathematical Modeling for the Quality Assurance of Continuous Pharmaceutical Manufacturing Processes

B Nagy - 2021 - search.proquest.com
As the pharmaceutical industry is increasingly implementing continuous manufacturing
techniques, and the QbD and PAT paradigms are explicitly encouraged by the regulatory …