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Principled Structured Incorporation of Clinical Knowledge Into Strategic Development Decisions.

Abstract：

:Efficient use of limited pharmaceutical product development resources requires integrating multiple attributes, such as efficacy, safety, pharmacology, and so on, to decide at any stage whether the development of a product should proceed aggressively or slowly or be terminated. The decision process proceeds most effectively when the knowledge and experience of a product development team are transparently and reproducibly integrated with the findings from completed experiments and trials. In this article, the authors describe an approach for quantitatively and objectively assessing evidence at any stage of development, one based on a mathematical combination of sets of pairwise comparisons. The attributes of the process and the rules for combining its elements to guide decisions are determined by the project team and other stakeholders before obtaining the determinative data to facilitate exploration of the sensitivity of a recommended action to various assumptions. Its statistical properties can be evaluated with standard statistical decision analysis methods.

journal_name

Ther Innov Regul Sci

journal_title

Therapeutic innovation & regulatory science

authors

Gould AL,Krishna R,Khan A,Saltzman J

doi

10.1177/2168479014558273

subject

Has Abstract

pub_date

2015-03-01 00:00:00

pages

289-296

issue

2

eissn

2168-4790

issn

2168-4804

journal_volume

49

pub_type

杂志文章

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