Learning versus confirming in clinical drug development*
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
The credibility assessment process is consistent with the 'learn-confirm paradigm'.
“This is consistent with the “learn‐confirm paradigm.”18”
Cited by
Sorted by citations
Workgroup, E. M., Marshall, S., Burghaus, R., Cosson, V, Cheung, S., Chenel, M., DellaPasqua, O., Frey, N., Hamrén, B., Harnisch, L., et al. (2016) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12049 · Cited by 373 · see citing works
Pharmacokinetic/Pharmacodynamic Modeling in Drug Development
Sheiner, L. B., & Steimer, J.-L. (2000) · Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev.pharmtox.40.1.67 · Cited by 351 · see citing works
Model-Based Drug Development: A Rational Approach to Efficiently Accelerate Drug Development
Milligan, P. A., Brown, M. J., Marchant, B., Martin, S. W., van der Graaf, P. H., Benson, N., Nucci, G., Nichols, D. J., Boyd, R. A., Mandema, J. W., et al. (2013) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2013.54 · Cited by 238 · see citing works
Model‐Informed Drug Development: Current US Regulatory Practice and Future Considerations
Wang, Y., Zhu, H., Madabushi, R., Liu, Q., Huang, S., & Zineh, I. (2019) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1363 · Cited by 228 · see citing works
Cummings, J., Ritter, A., & Zhong, K. (2018) · Journal of Alzheimer's Disease · doi:10.3233/jad-179901 · Cited by 176 · see citing works
Kuemmel, C., Yang, Y., Zhang, X., Florian, J., Zhu, H., Tegenge, M., Huang, S., Wang, Y., Morrison, T., & Zineh, I. (2020) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12479 · Cited by 177 · see citing works
“18 Although this paradigm is germane to the process of establishing and assessing credibility, the framework does not describe model building and refinement and instead focuses on regulatory applications.”
BackgroundNovel Methods and Technologies for 21st-Century Clinical Trials: A Review
Dorsey, E. R., Venuto, C., Venkataraman, V., Harris, D. A., & Kieburtz, K. (2015) · JAMA Neurology · doi:10.1001/jamaneurol.2014.4524 · Cited by 118 · see citing works
Friedrich, C. (2016) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1002/psp4.12056 · Cited by 87 · see citing works
The Use of Biomarkers in Human Pharmacology (Phase I) Studies
Cohen, A. F., Burggraaf, J., van Gerven, J. M. A., Moerland, M., & Groeneveld, G. J. (2015) · Annual Review of Pharmacology and Toxicology · doi:10.1146/annurev-pharmtox-011613-135918 · Cited by 55 · see citing works
Next-Generation Model-Based Drug Discovery and Development: Quantitative and Systems Pharmacology
Allerheiligen, S. R. B. (2010) · Clinical Pharmacology & Therapeutics · doi:10.1038/clpt.2010.81 · Cited by 56 · see citing works
Barrett, J. S., Bishai, R., Bucci‐Rechtweg, C., Cheung, A., Corriol‐Rohou, S., Haertter, S., James, A., Kovacs, S. J., Liu, J., Potempa, D., et al. (2018) · Clinical Pharmacology & Therapeutics · doi:10.1002/cpt.1000 · Cited by 38 · see citing works
Helmlinger, G., Al-Huniti, N., Aksenov, S., Peskov, K., Hallow, K. M., Chu, L., Boulton, D., Eriksson, U., Hamrén, B., Lambert, C., et al. (2017) · European Journal of Pharmaceutical Sciences · doi:10.1016/j.ejps.2017.05.028 · Cited by 33 · see citing works
Mishra, H., Polak, S., Jamei, M., & Rostami‐Hodjegan, A. (2014) · CPT: Pharmacometrics & Systems Pharmacology · doi:10.1038/psp.2014.26 · Cited by 24 · see citing works
- Authors
- Sheiner, L. B.
- Affiliations
- University of California, San Francisco (US)
- Corresponding author
- Sheiner, Lewis B.
- Venue
- Clinical Pharmacology & Therapeutics
- Publisher
- Wiley
- Published
- 1997-03
- Volume
- 61
- Issue
- 3
- Pages
- 275-291
- ISSN
- 0009-9236 (ISSN-L)
- 1532-6535
- OpenAlex
- W2140604471
- Cited by
- 633
- References
- 0
- Citations by year
- 2026: 7 · 2025: 19 · 2024: 22 · 2023: 19 · 2022: 28 · 2021: 32 · 2020: 19 · 2019: 35 · 2018: 22 · 2017: 25 · 2016: 27 · 2015: 16 · 2014: 29 · 2013: 40 · 2012: 34
- FWCI
- 5.09
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Clinical Pharmacology & Therapeutics (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (5p50gm026691-18)
- National Institute of General Medical Sciences (GM-26691, GM-26676)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Pharmaceutical studies and practices
- Life Sciences › Pharmacology, Toxicology and Pharmaceutics › Pharmacology › Pharmaceutical industry and healthcare
- Keywords
- clinical development, hypothesis testing, clinical trial design
- MeSH terms
- Bronchodilator Agents, Clinical Trials as Topic, Dose-Response Relationship, Drug, Drug Industry, Humans, Research Design, Respiratory Insufficiency, Theophylline, Time Factors, Drugs, Investigational, Randomized Controlled Trials as Topic, Treatment Outcome
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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