Abstract: Methods, systems and equipment useful for monitoring in vivo activities of CCI-779 or other drugs. Numerous drug activity genes can be identified by the present invention. The expression profiles of these genes in peripheral blood mononuclear cells are modulatable by CCI-779 or other drugs. Therefore, these genes can be used as surrogate markers for detecting or monitoring drug activities in vivo.

Abstract: A CCI-779 oral dosage form is provided in which, after oral administration to a subject, the CCI-779 has a whole blood peak concentration (Cmax) of 5.4±1.8 ng/mL and an area under the curve (AUC) of about 66±about 22 ng-hr/ml and the sirolimus has a Cmax of 18.7±9.6 ng/mL and an AUC of about 600±about 228 ng-hr/ml, for a 25 mg unit dose of CCI-779. Another CCI-779 oral dosage form is provided which, after oral administration thereof to a subject, the CCI-779 has a Cmax of 5.7±1.7 ng/mL and an AUC of about 60±about 20 ng-hr/ml and the sirolimus has a Cmax of 17.1±8.1 ng/mL and an AUC of about 548±about 187 ng-hr/ml in whole blood, for a 25 mg unit dose of CCI-779. Products containing these oral dosage forms, and methods of use thereof, are also described.

Abstract: Methods, systems and equipment useful for monitoring in vivo activities of CCI-779 or other drugs. Numerous drug activity genes can be identified by the present invention. The expression profiles of these genes in peripheral blood mononuclear cells are modulateable by CCI-779 or other drugs. Therefore, these genes can be used as surrogate markers for detecting or monitoring drug activities in vivo.