| 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. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Germany | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 1,856 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United Kingdom | 3 | <1% |
| India | 3 | <1% |
| Nigeria | 2 | <1% |
| Netherlands | 1 | <1% |
| Ireland | 1 | <1% |
| Malaysia | 1 | <1% |
| Turkey | 1 | <1% |
| Germany | 1 | <1% |
| Ecuador | 1 | <1% |
| Other | 1 | <1% |
| Unknown | 1841 | 99% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Student > Master | 294 | 16% |
| Student > Ph. D. Student | 259 | 14% |
| Student > Bachelor | 196 | 11% |
| Researcher | 178 | 10% |
| Other | 66 | 4% |
| Other | 210 | 11% |
| Unknown | 653 | 35% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 425 | 23% |
| Engineering | 135 | 7% |
| Chemical Engineering | 117 | 6% |
| Chemistry | 116 | 6% |
| Biochemistry, Genetics and Molecular Biology | 95 | 5% |
| Other | 232 | 13% |
| Unknown | 736 | 40% |
Attention Score in Context
This research output has an Altmetric Attention Score of 32. 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 06 March 2024.
All research outputs
#1,249,363
of 25,425,223 outputs
Outputs from The AAPS Journal
#24
of 1,464 outputs
Outputs of similar age
#12,015
of 239,986 outputs
Outputs of similar age from The AAPS Journal
#4
of 20 outputs
Altmetric has tracked 25,425,223 research outputs across all sources so far. Compared to these this one has done particularly well and is in the 95th percentile: it's in the top 5% of all research outputs ever tracked by Altmetric.
So far Altmetric has tracked 1,464 research outputs from this source. They typically receive a little more attention than average, with a mean Attention Score of 6.0. This one has done particularly well, scoring higher than 98% of its peers.
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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 well, scoring higher than 85% of its contemporaries.