Can the flow of medicines be improved? Fundamental pharmacokinetic and pharmacological principles toward improving Phase II survival
P Morgan, PH Van Der Graaf, J Arrowsmith… - Drug discovery today, 2012 - Elsevier
P Morgan, PH Van Der Graaf, J Arrowsmith, DE Feltner, KS Drummond, CD Wegner…
Drug discovery today, 2012•ElsevierIn an effort to uncover systematic learnings that can be applied to improve compound
survival, an analysis was performed on data from Phase II decisions for 44 programs at
Pfizer. It was found that not only were the majority of failures caused by lack of efficacy but
also that, in a large number of cases (43%), it was not possible to conclude whether the
mechanism had been tested adequately. A key finding was that an integrated understanding
of the fundamental pharmacokinetic/pharmacodynamic principles of exposure at the site of …
survival, an analysis was performed on data from Phase II decisions for 44 programs at
Pfizer. It was found that not only were the majority of failures caused by lack of efficacy but
also that, in a large number of cases (43%), it was not possible to conclude whether the
mechanism had been tested adequately. A key finding was that an integrated understanding
of the fundamental pharmacokinetic/pharmacodynamic principles of exposure at the site of …
In an effort to uncover systematic learnings that can be applied to improve compound survival, an analysis was performed on data from Phase II decisions for 44 programs at Pfizer. It was found that not only were the majority of failures caused by lack of efficacy but also that, in a large number of cases (43%), it was not possible to conclude whether the mechanism had been tested adequately. A key finding was that an integrated understanding of the fundamental pharmacokinetic/pharmacodynamic principles of exposure at the site of action, target binding and expression of functional pharmacological activity (termed together as the ‘three Pillars of survival’) all determine the likelihood of candidate survival in Phase II trials and improve the chance of progression to Phase III.
Elsevier