Literature DB >> 12811358

Hypothesis: a single clinical trial plus causal evidence of effectiveness is sufficient for drug approval.

Carl C Peck1, Donald B Rubin, Lewis B Sheiner.   

Abstract

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Year:  2003        PMID： 12811358     DOI： 10.1016/S0009-9236(03)00018-3

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


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  17 in total

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Review 9.  Integrated pharmacokinetics and pharmacodynamics in drug development.

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10.  Proposals for model-based paediatric medicinal development within the current European Union regulatory framework.

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Journal:  Br J Clin Pharmacol       Date:  2009-10       Impact factor: 4.335
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