[New clinical technologies in drug development].
The integration of functional imaging and therapeutic nuclear medicine technologies mainly in the early phases of drug development (clinical technologies implementation, CTI) is a relatively young option, which has amply influenced drug development concepts in the pharmaceutical industry. Over the past 15 years, the greatest risk reduction in drug development decision making has resulted from the earlier involvement of drug metabolism in the optimization stage of drug design rather than the late-stage characterization of target molecules. Go/no-go decisions of drug development programs and drug dosage can also be inferred from these techniques, which lead to decreases in time and costs. Not only is CTI effectively used in early drug development, but also in later clinical study phases (phases 3b/4) as a therapy monitoring or follow-up instrument. In addition, CTI is interesting and promising for the development of new therapy concepts in nuclear medicine which involve the application of monoclonal antibodies and peptides for treatment of different hematologic-oncologic diseases.
Otte
A
A
Zentrum Klinische Studien, Universitätsklinikum Freiburg, Elsässer Strasse 2, 79110 Freiburg. andreas.otte@uniklinik-freiburg.de
Rosé
C
C
Zähringer
A
A
Maier-Lenz
H
H
D002986:Clinical Trials as Topic / Q000379:methods* / Q000639:trends*; D016503:Drug Delivery Systems / Q000379:methods* / Q000639:trends*; D015195:Drug Design; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000639:trends*