Quality by design case study: An integrated multivariate approach to drug product and process development

2009 ◽  
Vol 382 (1-2) ◽  
pp. 23-32 ◽  
Author(s):  
Jun Huang ◽  
Goldi Kaul ◽  
Chunsheng Cai ◽  
Ramarao Chatlapalli ◽  
Pedro Hernandez-Abad ◽  
...  
Keyword(s):  
Quality By Design ◽  
Process Development ◽  
Drug Product ◽  
Multivariate Approach ◽  
Design Case ◽  
Product And Process ◽  
Design Case Study

scholarly journals An industrial case study: QbD to accelerate time-to-market of a drug product

AAPS Open ◽  
2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Madalena Testas ◽  
Tiago da Cunha Sais ◽  
Leonardo Piccoli Medinilha ◽  
Katia Nami Ito Niwa ◽  
Lucas Sponton de Carvalho ◽  
...  
Keyword(s):  
Process Development ◽  
Drug Product ◽  
Pharmaceutical Products ◽  
Product Knowledge ◽  
Industrial Case Study ◽  
Actual Application ◽  
Product And Process Knowledge ◽  
Product And Process ◽  
Regulatory Flexibility

AbstractThe use of a Quality by Design (QbD) approach in the development of pharmaceutical products is known to bring many advantages to the table, such as increased product and process knowledge, robust manufacturing processes, and regulatory flexibility regarding changes during the commercial phase. However, many companies still adhere to a more traditional pharmaceutical process development—in some cases due to the difficulty of going from a theoretical view of QbD to its actual application. This article presents a real-world case study for the development of an industrial pharmaceutical drug product (oral solid dosage form) using the QbD methodology, demonstrating the activities involved and the gains in obtaining systematic process and product knowledge.

Developing A Digital Psychoeducational Tool to Reduce Loneliness in Older Adults: A Design Case Study

2021 ◽  
pp. 1-30
Author(s):  
Abdullah Al Mahmud ◽  
Katrina M. Long ◽  
Karra D. Harrington ◽  
Kit Casey ◽  
Sunil Bhar ◽  
...  
Keyword(s):  
Older Adults ◽  
Design Case ◽  
Design Case Study

scholarly journals Experimental and Numerical Analysis of a Novel Display Case Design: Case Study of the Renovated Anne Frank House

2019 ◽  
Vol 65 (5) ◽  
pp. 262-284
Author(s):  
Karin Kompatscher ◽  
Bart Ankersmit ◽  
Edgar Neuhaus ◽  
Marcel A.P. van Aarle ◽  
Jos W.M. van Schijndel ◽  
...  
Keyword(s):  
Numerical Analysis ◽  
Design Case ◽  
Design Case Study ◽  
Case Design ◽  
Anne Frank

Uplifting Us: A BIPOC Game Design Case Study

2021 ◽  
Author(s):  
Christopher Brooks ◽  
Erica Principe Principe Cruz ◽  
Jamie Camera ◽  
Alexandra To
Keyword(s):  
Game Design ◽  
Design Case ◽  
Design Case Study
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