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Understanding Pharmaceutical Quality by Design

Overview of attention for article published in The AAPS Journal, May 2014
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About this Attention Score

  • In the top 25% of all research outputs scored by Altmetric
  • Among the highest-scoring outputs from this source (#49 of 854)
  • High Attention Score compared to outputs of the same age (87th percentile)
  • High Attention Score compared to outputs of the same age and source (95th percentile)

Mentioned by

news
1 news outlet
twitter
1 tweeter
facebook
1 Facebook page

Citations

dimensions_citation
289 Dimensions

Readers on

mendeley
540 Mendeley
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Title
Understanding Pharmaceutical Quality by Design
Published in
The AAPS Journal, May 2014
DOI 10.1208/s12248-014-9598-3
Pubmed ID
Authors

Lawrence X. Yu, Gregory Amidon, Mansoor A. Khan, Stephen W. Hoag, James Polli, G. K. Raju, Janet Woodcock

Abstract

This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

Twitter Demographics

The data shown below were collected from the profile of 1 tweeter who shared this research output. Click here to find out more about how the information was compiled.

Mendeley readers

The data shown below were compiled from readership statistics for 540 Mendeley readers of this research output. Click here to see the associated Mendeley record.

Geographical breakdown

Country Count As %
India 3 <1%
United Kingdom 3 <1%
Nigeria 2 <1%
Ecuador 1 <1%
Ireland 1 <1%
Netherlands 1 <1%
Malaysia 1 <1%
Turkey 1 <1%
Argentina 1 <1%
Other 2 <1%
Unknown 524 97%

Demographic breakdown

Readers by professional status Count As %
Student > Master 132 24%
Student > Ph. D. Student 116 21%
Researcher 84 16%
Student > Bachelor 56 10%
Other 23 4%
Other 64 12%
Unknown 65 12%
Readers by discipline Count As %
Pharmacology, Toxicology and Pharmaceutical Science 163 30%
Engineering 66 12%
Chemistry 45 8%
Agricultural and Biological Sciences 43 8%
Medicine and Dentistry 41 8%
Other 87 16%
Unknown 95 18%

Attention Score in Context

This research output has an Altmetric Attention Score of 11. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 14 August 2019.
All research outputs
#1,611,313
of 14,269,298 outputs
Outputs from The AAPS Journal
#49
of 854 outputs
Outputs of similar age
#23,697
of 189,612 outputs
Outputs of similar age from The AAPS Journal
#1
of 20 outputs
Altmetric has tracked 14,269,298 research outputs across all sources so far. Compared to these this one has done well and is in the 88th percentile: it's in the top 25% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 854 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 5.1. This one has done particularly well, scoring higher than 94% of its peers.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 189,612 tracked outputs that were published within six weeks on either side of this one in any source. This one has done well, scoring higher than 87% of its contemporaries.
We're also able to compare this research output to 20 others from the same source and published within six weeks on either side of this one. This one has done particularly well, scoring higher than 95% of its contemporaries.