ABSTRACT
As the expense in developing therapeutic pharmaceutical compounds continues to increase and the success rate for getting such compounds approved for marketing and to the patients needing these treatments continues to decrease (see Section 1.2), a focused effort has emerged in improving the communication and planning between basic and clinical science. This will probably lead to more therapeutic insights being
derived from new scientific ideas, and more feedbacks being provided to researchers so that their approaches are better targeted. TM spans all the disciplines and activities that lead to making key scientific decisions, as a compound that traverses across the difficult preclinical-clinical divide. Many argue that improvement in making correct decisions on what dose and regimen should be pursued in the clinic, the anticipated human safety risks of a compound, the probable drug interactions, and the pharmacologic behavior of the compound are very likely to be the most important decisions made in the entire development process. Many of these decisions and the path for uncovering this information within later development are defined at this specific time within the drug development process. Improving these decisions will probably lead to a substantial increase in the number of safe and effective compounds available to combat human diseases.
