Stable isotope techniques in early drug development: an economic evaluation.
Stable isotope labeled (SIL) drug methods are compared with standard methods for performing early (phases I and IIa) drug development studies (mass balance, bioavailability, single-dose volunteer and patient, multiple-dose volunteer and patient). SIL methods offer considerable reduction in the cost (> 50%) and number of subjects (67%) required for bioavailability and multiple-dose patient studies. Moreover, a complete early drug development program is described for optimally combining SIL and standard studies, which can reduce cost by 23% and number of subjects by 36% compared with a program using standard methods. These reductions should result in development time savings of at least one year.
Browne
T R
TR
Department of Neurology, Boston University School of Medicine, Massachusetts, USA.
D017321:Clinical Trials, Phase I as Topic / Q000191:economics* / Q000379:methods; D017322:Clinical Trials, Phase II as Topic / Q000191:economics* / Q000379:methods; D006801:Humans; D007553:Isotope Labeling / Q000379:methods*; D010599:Pharmacokinetics; D010600:Pharmacology