What Are the Pre-Requisites for a Biowaiver

It is a general requirement for an optimal therapeutic effect that the active pharmaceutical ingredient (API) is delivered to the site of action in order to provide effective but not toxic concentration levels. Therefore, studies to measure BA are of great importance in order to support new drug product applications. Thus, data on the BA of orally administered drug products is a general requirement to the development 

Well-defined physiological factors pH value Concentration of salts Surfactants Enzymes 

Less well-defined physiological factors Agitation 

Verification of method Comparison to relevant in vivo data 

Typically, BA and BE are assessed by cumbersome and expensive studies in human volunteers. But, under certain circumstances, regulatory agencies may waive the requirement for the submission of evidence measuring the in vivo BA or establishing BE. This is referred to as a biowaiver . The application of a biowaiver requires that supportive in vitro dissolution data are meaningful in terms of in vivo performance of the drug product. 

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