Title |
Guidelines for the Quality Control of Population Pharmacokinetic–Pharmacodynamic Analyses: an Industry Perspective
|
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Published in |
The AAPS Journal, July 2012
|
DOI | 10.1208/s12248-012-9387-9 |
Pubmed ID | |
Authors |
P. L. Bonate, A. Strougo, A. Desai, M. Roy, A. Yassen, J. S. van der Walt, A. Kaibara, S. Tannenbaum |
Abstract |
Quality population modeling and simulation analyses and reports are something every modeler desires. However, little attention in the literature has been paid to what constitutes quality regarding population analyses. Very rarely do published manuscripts contain any statement about quality assurance of the modeling results contained therein. The purpose of this manuscript is to present guidelines for the quality assurance of population analyses, particularly with regards to the use of NONMEM from an industrial perspective. Quality guidelines are developed for the NONMEM installation itself, NONMEM data sets, control streams, output listings, output data files and resultant post-processing, reporting of results, and the review processes. These guidelines were developed to be thorough yet practical, though are not meant to be completely comprehensive. It is our desire to ensure that what is reported accurately reflects the collected data, the modeling process, and model outputs for a modeling project. |
X Demographics
Geographical breakdown
Country | Count | As % |
---|---|---|
Australia | 1 | 100% |
Demographic breakdown
Type | Count | As % |
---|---|---|
Members of the public | 1 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Australia | 1 | 1% |
Brazil | 1 | 1% |
Canada | 1 | 1% |
Russia | 1 | 1% |
Japan | 1 | 1% |
United States | 1 | 1% |
Unknown | 88 | 94% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Researcher | 26 | 28% |
Student > Ph. D. Student | 20 | 21% |
Other | 9 | 10% |
Student > Master | 7 | 7% |
Student > Doctoral Student | 4 | 4% |
Other | 13 | 14% |
Unknown | 15 | 16% |
Readers by discipline | Count | As % |
---|---|---|
Pharmacology, Toxicology and Pharmaceutical Science | 28 | 30% |
Medicine and Dentistry | 24 | 26% |
Agricultural and Biological Sciences | 13 | 14% |
Unspecified | 2 | 2% |
Business, Management and Accounting | 2 | 2% |
Other | 8 | 9% |
Unknown | 17 | 18% |