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Clinical
Trial5/16/2014
• Clinical trials are set up in a way to assess the
methods and procedures that offers new treatment
effectively and safely to patients.
• The new treatments must prove to be safe and secure
and efficient in scientific studies with a specific
amount of patients prior to making the same available
to all the patients.
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 Involve human subjects.
 Move forward in time.
 Most have a comparison CONTROL group.
 Must have method to measure intervention.
 Focus on unknowns: effect of medication.
5/16/2014
 Must be done before medication is part of
standard of care.
 Test a certain hypothesis.
 Study protocol must be built on ethical science.
 Control for any potential biases.
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 In recent years, marine natural product bio-prospecting has yielded a
considerable number of drug candidates.
 Research into the ecology of marine natural products has shown that
many of these compounds function as chemical weapons and have evolved
into highly potent inhibitors of physiological processes in the competitors
of the marine organisms that use them.
 Most of these molecules are still in preclinical or early clinical
development but some are already on the market.
5/16/2014
 Some of the natural products isolated from marine
invertebrates have been shown to be microbial origin and
this is the case for the majority of such molecules.
 Marine microorganisms, whose immense genetic and
biochemical diversity is only beginning to be appreciated,
look likely to become a rich source of novel chemical
entities for the discovery of more effective drugs.
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