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Stable Isotope Techniques in Early Drug Development: An Economic Evaluation
Author(s) -
Browne Thomas R.
Publication year - 1998
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1998.tb04418.x
Subject(s) - bioavailability , volunteer , drug development , drug , medicine , pharmacology , isotope , biology , agronomy , physics , quantum mechanics
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.