Advancement in metabolism profiling approaches and bioanalytical techniques has been revolutionized over the last two decades. Different in vitro and in vivo approaches along with advanced bioanalytical techniques are enabling the accurate qualitative and quantitative analysis of metabolites. This review summarizes various modern in vitro and in vivo approaches for executing metabolism studies with special emphasis on the recent advancement in the field. Advanced bioanalytical techniques, which can be employed in metabolism studies, have been discussed suggesting their particular application based on specific study objectives. This article can efficiently guide the researchers to scientifically plan metabolism studies and their bioanalysis during drug development programs taking advantage of a detailed understanding of instances of failure in the past.

Duvelisib is a dual inhibitor of phosphoinositide 3 kinase that received global approval by the US Food and Drug Administration in 2018 to treat follicular lymphoma after at least two prior systemic therapies. An extensive literature search revealed that, to date, metabolites of duvelisib have not been characterized and information on them is not available in any of the literature. Moreover, the metabolism pathway is yet to be established. This study aimed to investigate and characterize the metabolites of duvelisib generated in microsomes and S9 fractions. In this study, five duvelisib metabolites were identified using UHPLC-Q-TOF-MS/MS anal-

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