The goal of this book is to improve the readers' knowledge of
metabolite elucidation in drug metabolism by exposing them to in
depth coverage of the biotransformation of xenobiotics, strategies
for identifying and characterizing metabolites, FDA guidelines, and
case studies on how to improve the decision-making process in
structural modification of drug candidates to reduce toxicity.
The book consists of 8 chapters; it first provides an
introduction on biotransformation of xenobiotics, and then presents
modern approaches and strategies for dealing with metabolite
characterization, using tools such as LC-MS, H-D exchange, stable
isotopes LC-MS-NMR, and radiolabeled compounds. Also, strategies
for dealing with reactive intermediates in drug discovery and
development are presented as well as case studies on improving the
decision-making process in the structural modification of drug
candidates. The last chapter discusses the regulatory perspectives
of safety testing of drug metabolites and why, how, and when to
test their safety.
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