To develop effective and safe drugs and to take them to the market in short period of time is
the mission of pharmaceutical research companies. A selection of few of the lead compounds are done
for the evaluation of safety and their ADMET (absorption, distribution, metabolism, excretion and toxicology)
properties are tested in in-vitro (test systems), in-vivo (living organisms) and in-silico (computational
methods). From initial stages to final stages of modern drug discovery processes, the vital tool
for detecting and characterizing metabolites is MS (Mass spectrometry) hyphenated with other techniques.
The methods used for generation of metabolites are in vitro techniques and cell lines (containing
expressing drug metabolizing enzymes and heterologous genes). The use of HPLC-MS/UPLC-MS
and high resolution MS, enables the in depth metabolite detection and profiling studies and it may also
be likely to identify and characterize the site and types of biotransformation.
Keywords: Forced degradation study, biotransformation, regioselective, preformulation, ICH, pharmacokinetics.
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