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In phase I studies the problem arises as to choosing the starting dose
and escalation scheme. Often this problem is solved by allometric
scaling the pharmacokinetic parameters, Cl and Vd, based only on
preclinical animal data and going from there. After the study is
completed, there is a natural tendency to look back and see how well the
observed pk compared to the predicted pk based on scaling.
Does anyone have any recommendations (references?) regarding how good is
good enough? Someone once told me that if you were within a factor of
10 then your scaling was "successful". Would most people agree with
Any help on this would be appreciated. Thanks.
Peter L. Bonate, Ph.D.
Hoechst Marion Roussel
P.O. Box 9627 (F4-M3112)
Kansas City, MO 64134
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