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Evidence of effectiveness: How much can we extrapolate from existing studies?

Drug development can be a science of extrapolation if the use of a drug exposure-response relationship is embraced and implemented through mechanistically oriented pharmacokinetic (PK)-pharmacodynamic (PD) modeling analysis and clinical trial simulation. The traditional requirement of at least 2 ade...

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Detalhes bibliográficos
Main Authors: Lee, Howard, Yim, Dong-Seok, Zhou, Honghui, Peck, Carl C.
Formato: Artigo
Idioma:Inglês
Publicado em: Springer-Verlag 2005
Assuntos:
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC2750984/
https://ncbi.nlm.nih.gov/pubmed/16353924
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1208/aapsj070247
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