Controlled-release systems bioequivalence

Another circumstance in which there may be generally compelling reasons to require quantification of active metabolites is when a controlled-release drug-delivery system is used for a drug that has an active metabolite. Some of the papers that consider the topics of bioequivalency testing for drugs with long half-lives or active metabolites are listed in the references section of this chapter [12-17]. 

E. Lipka and G. L. Amidon, Setting bioequivalence requirements for drug development based on preclinical data optimizing oral drug delivery systems, J. Controlled Release, 62, 41 (1999). 

Marroum, P. J. (1997), Bioavialability/Bioequivalence for Oral Release Producs, Controlled Release Drug Delivery Systems. Paper presented at the 5th Int. Symp. Drug Del., East Brunswick, NJ, May 15-17. 

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