| Title |
A Science and Risk-Based Pragmatic Methodology for Blend and Content Uniformity Assessment
|
|---|---|
| Published in |
AAPS PharmSciTech, December 2017
|
| DOI | 10.1208/s12249-017-0925-8 |
| Pubmed ID | |
| Authors |
Naheed Sayeed-Desta, Ajay Babu Pazhayattil, Jordan Collins, Chetan Doshi |
| Abstract |
This paper describes a pragmatic approach that can be applied in assessing powder blend and unit dosage uniformity of solid dose products at Process Design, Process Performance Qualification, and Continued/Ongoing Process Verification stages of the Process Validation lifecycle. The statistically based sampling, testing, and assessment plan was developed due to the withdrawal of the FDA draft guidance for industry "Powder Blends and Finished Dosage Units-Stratified In-Process Dosage Unit Sampling and Assessment." This paper compares the proposed Grouped Area Variance Estimate (GAVE) method with an alternate approach outlining the practicality and statistical rationalization using traditional sampling and analytical methods. The approach is designed to fit solid dose processes assuring high statistical confidence in both powder blend uniformity and dosage unit uniformity during all three stages of the lifecycle complying with ASTM standards as recommended by the US FDA. |
X Demographics
The data shown below were collected from the profiles of 2 X users who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| United States | 1 | 50% |
| Unknown | 1 | 50% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Members of the public | 2 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 22 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 22 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Other | 5 | 23% |
| Researcher | 4 | 18% |
| Student > Ph. D. Student | 3 | 14% |
| Student > Master | 1 | 5% |
| Professor | 1 | 5% |
| Other | 0 | 0% |
| Unknown | 8 | 36% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 10 | 45% |
| Agricultural and Biological Sciences | 1 | 5% |
| Chemistry | 1 | 5% |
| Engineering | 1 | 5% |
| Unknown | 9 | 41% |
Attention Score in Context
This research output has an Altmetric Attention Score of 2. 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 12 February 2020.
All research outputs
#13,594,543
of 23,047,237 outputs
Outputs from AAPS PharmSciTech
#875
of 1,474 outputs
Outputs of similar age
#217,156
of 440,110 outputs
Outputs of similar age from AAPS PharmSciTech
#8
of 23 outputs
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We're also able to compare this research output to 23 others from the same source and published within six weeks on either side of this one. This one has gotten more attention than average, scoring higher than 65% of its contemporaries.