REGULATORY APPLICATIONS

Although there is considerable activity in developing computational toxicology for regulatory applications, the reality for the foreseeable future is that QSARs and related techniques are not yet sophisticated enough to replace whole animal testing. 

The BCS has been developed primarily for regulatory applications, although its use has been extended beyond this area (as discussed in more detail below). The aim of the BCS in a regulatory context is to provide a basis for replacing certain bioequivalence studies by equally or more accurate in vitro dissolution tests. This could reduce costs and time in the development process as well as reducing unnecessary drug exposure in healthy volunteers, which is normally the study population in bioequivalence studies. 

Center for Drug Evaluation and Research (CEDR) Postmarketing Surveillance Programs, www.fda.gov/cder/regulatory/applications/postmarketing/ surveillancepost.htm (accessed May 24, 2002). 

Discovery Preclinical Clinical Regulatory Application Approval... 

In some cases, drug materials are isolated from natural products. In other cases, natural product extraction constitutes the raw material or intermediate for production of the drug via a semisynthetic route. Methods for chemical reactions, product purification, control parameters, and analytical procedures are developed and they form the basis for the chemistry, manufacturing, and control (CMC) information for regulatory application. 

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