2009
DOI: 10.1016/j.ijpharm.2009.07.031
|View full text |Cite
|
Sign up to set email alerts
|

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

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
2
1
1

Citation Types

0
122
0
5

Year Published

2011
2011
2017
2017

Publication Types

Select...
4
3

Relationship

0
7

Authors

Journals

citations
Cited by 184 publications
(127 citation statements)
references
References 10 publications
0
122
0
5
Order By: Relevance
“…The recommendations were then provided to the commercial site to guide the design of scale-up trials. c) Design space based on integrated multivariate approach: In another case, a design space was defined on the basis of DOE, optimization, and multivariate analysis (MVA) [12]. Initially, a screening DOE was carried out to identify the parameters that have an impact on the finished product's CQA.…”
Section: Design Spacementioning
confidence: 99%
See 1 more Smart Citation
“…The recommendations were then provided to the commercial site to guide the design of scale-up trials. c) Design space based on integrated multivariate approach: In another case, a design space was defined on the basis of DOE, optimization, and multivariate analysis (MVA) [12]. Initially, a screening DOE was carried out to identify the parameters that have an impact on the finished product's CQA.…”
Section: Design Spacementioning
confidence: 99%
“…Following the screening DOE, an optimization DOE was carried out to evaluate the effects of the design factors on manufacturability and final product's CQA such as tablet blend flow and tablet dissolution and to establish a design space to ensure CQAs. Figure 2.4 is a schematic rendition of the methodology for design space development and implementation, as presented by Huang et al [12]. As illustrated in Figure 2.4, design space was established as a response surface model based on DOE data.…”
Section: Design Spacementioning
confidence: 99%
“…(1) (2) Novel reliability evaluation procedures for a response surface and an optimal solution have been applied in this technique.…”
Section: Bs Resamplingmentioning
confidence: 99%
“…Therefore, it is necessary to establish a design space to identify multidimensional combinations and interactions of the many causal factors that determine the quality of the target. 2) When describing a design space, a design of experiments (DOE) is effectively used for determining the relationship between factors affecting a process and the output of the process. 3,4) Moreover, a response surface method (RSM) is useful for the visual understanding of factors and the facilitation of the clarification of problems to be solved for optimization in a pharmaceutical development study.…”
mentioning
confidence: 99%
“…5 In recent years, several contributions have been reported to develop new processes under the framework of QbD using modeling methods including first-principle models, 6,7 response surface models based on design of experiments 8,9,10 and multivariate statistical models. 2,11,12 For developing a tablet production process which consists of multiple units, it is difficult to establish a deterministic model to describe the process comprehensively. However, multivariate statistical models are useful tools to improve understandings via identifying the critical material attributes (CMAs) and critical process parameters affecting the quality of the final product, and identifying the most important mechanisms of the production process.…”
Section: Introductionmentioning
confidence: 99%