Congestive heart failure definition

Cardiotoxicity, which can lead to congestive heart failure and death, is a toxic effect of the anticancer drug, doxorubicin. A cumulative dose-effect analysis demonstrated that doxorubicin cardiotoxicity is related to the lifetime dose of the drug (Figure 18.12) and provided the basis for the definition of safe lifetime dose levels (7). The lifetime dose of doxorubicin is now limited to less than 400-450 mg/m, which is associated with a <5% risk of developing congestive heart failure. 

An example of a project definition in the biophar-maceutical industry would be the development of a new chemical entity for the indication of treating mild to severe congestive heart failure (CHE)/ with both an oral and an intravenous formulation being developed/ and with a projected development time of 3 years to NDA submission and a budget of 75/000/000. A sub-project would be to complete a clinical POC for the severe CHE indication for the intravenous formulation in 1 year with a budget of 9/000/000. 

Definition of abbreviations BMS, bone marrow suppression CCS, cell-cycle specific CHF, congestive heart failure GI, gastrointestinal. 

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