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With the technical advances of recent years, novel radiation techniques have been introduced such as intensity modulated radiotherapy (IMRT) and its rotational subform volumetric modulated arc therapy (VMAT) [8, 9]

Specifically, the guidance states that for abbreviated new drug applications (ANDAs), once the sameness of the active pharmaceutical ingredient (API) between the generic product and the reference listed drug is established, developers can mitigate the residual risk of unwanted immunogenicity response by using in silico and in vitro tools to characterize differences in product- and process-related impurities between the reference and generic drug products