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I have been asked to give some input on an animal study design,
investigating the pharmacodynamic interaction between caffeine and a
drug candidate. Both caffeine and the drug can be given
intravenously. There are no PK interactions involved.
I would like to implement the best design and would appreciate any
comments and suggestions. I am considering a PK/PD modeling and hence
would like to administer different doses. The question is what to
change from one experiment to another. We know the dose of the
compound to achieve a maximum effect. Would it be informative if this
maximum dose was administered together with varying doses of
caffeine? Should we change both the drug and caffeine doses at each
experiment? Or should we keep the caffeine dose the same but change
the dose of the test drug at each experiment? The number of
experiments should be limited to 3-4. Same animals can be used for
Associate Director of Clinical Pharmacology
CV Therapeutics Inc.
3172 Porter Dr.
Palo Alto, CA 94304
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