Development of Rational Drug Combinations with Investigational Targeted Agents

Development of rational drug combinations with investigational targeted agents.

Development of Rational Drug Combinations with Investigational Targeted Agents

Rational Combinations of Targeted Agents in AML

Despite modest improvements in survival over the last several decades, the treatment of AML continues to present a formidable challenge. Most patients are elderly, and these individuals, as well as those with secondary, therapy-related, or relapsed/refractory AML, are particularly difficult to treat, owing to both aggressive disease biology and the high toxicity of current chemotherapeutic regi...

Selecting Rational Drug Combinations in Epilepsy.

Monotherapy remains the standard initial therapy of epilepsy, but when the first antiepileptic drug (AED) fails, combination therapy may be considered. The choice of combination therapy should take into consideration pharmacokinetic interactions, as well as pharmacodynamic interactions related to mechanism of action. There is evidence that an AED combination with different mechanisms of action ...

Leveraging exploratory investigational new drug studies to accelerate drug development.

In 2006, the U.S. Food and Drug Administration published its guide on exploratory investigational new drug (IND) studies with the goal of making the approach to early-stage, pilot clinical trials more flexible within the context of current regulations. The exploratory IND allows sponsors to initiate clinical trials of limited scale with reduced preclinical requirements. These studies may be imp...