STABLE-ISOTOPE TECHNIQUES IN EARLY DRUG DEVELOPMENT - AN ECONOMIC-EVALUATION

Stable isotope labeled (SIL) drug methods are compared with standard m ethods for performing early (phases I and IIa) drug development studie s (mass balance, bioavailability, single-dose volunteer and patient, m ultiple-dose volunteer and patient). Sn methods offer considerable red uction in the cost (>50%) and number of subjects (67%) required for bi oavailability and multiple-dose patient studies. Moreover, a complete early drug development program is described for optimally combining SI L and standard studies, which can reduce cost by 23% and number of sub jects by 36% compared with a program using standard methods. These red uctions should result in development time savings of at least one year .