| Experiences with learning and confirming in drug and biological development. | |
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MedLine Citation:
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PMID: 20648033 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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Since the 1997 landmark article by Dr. Lewis Sheiner in Clinical Pharmacology & Therapeutics, biopharmaceutical development in phases I-IIA has become more targeted toward learning (i.e., establishing proof of concept), then subsequently confirming that regulated standards are met. The purpose and importance of the learning-proof-of-concept phase is subjective but typically uses traditional statistics (which were developed for use in confirming). Two examples from development are presented to illustrate learning in practice. Suggestions for how to improve and embed the learn-confirm concept and how to enhance the contributions of clinical pharmacology and statistics are considered. |
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Authors:
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S D Patterson |
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Publication Detail:
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Type: Comment; Journal Article; Review |
Journal Detail:
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Title: Clinical pharmacology and therapeutics Volume: 88 ISSN: 1532-6535 ISO Abbreviation: Clin. Pharmacol. Ther. Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-07-21 Completed Date: 2010-08-12 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0372741 Medline TA: Clin Pharmacol Ther Country: United States |
Other Details:
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Languages: eng Pagination: 161-3 Citation Subset: AIM; IM |
Affiliation:
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Pfizer Vaccine Research, Philadelphia, Pennsylvania, USA. patters4@wyeth.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Biostatistics* Clinical Trials, Phase I as Topic Clinical Trials, Phase II as Topic Clinical Trials, Phase III as Topic Drug Discovery / statistics & numerical data, trends* Electrocardiography / drug effects Humans Linear Models Pharmacokinetics Pharmacology, Clinical / statistics & numerical data, trends* Research Design Serotyping Vaccines / therapeutic use |
| Chemical | |
Reg. No./Substance:
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0/Vaccines |
| Comments/Corrections | |
Comment On:
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Clin Pharmacol Ther. 1997 Mar;61(3):275-91
[PMID:
9084453
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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