EMA tackling antibiotics
September 29, 2015
THE European Medicines Agency
overnight released a draft guideline
on the use of pharmacokinetics and
pharmacodynamics analyses in the
development of antibiotics.
Open for public consultation, the
document aims to help facilitate
and speed up the development
of new antibiotics - particularly
those targeting multi-drug resistant
bacteria.
“The increasing emergence of
bacteria that have become resistant
to a wide range of antibiotics is
a major and global public health
issue,” the EMA said.
“New antibiotics are urgently
needed for the treatment of serious
infectious diseases, in particular
when patients have very limited or
no remaining treatment options”.
The EMA says a central pillar in
its strategy to fight antimicrobial
resistance is to “offer an
environment that stimulates
and facilitates development of
innovative antibiotics”.
The new document provides
guidance for the conduct of
robust pharmacokinetics and
pharmacodynamics analyses,
with modelling and simulation
methods conducted prior to
the start of human clinical trials
providing evidence about the
appropriateness of dose and
frequency of administration that
should be used in patients to
achieve optimal risk-benefit results.
If these analyses are conducted
in a robust manner they “have the
potential to reduce the size of the
clinical development program,” the
EMA said.
The draft guideline, which can be
viewed at www.ema.europa.eu, is
now open for public comment until
31 Mar 2016.
The above article was sent to subscribers in Pharmacy Daily's issue from 29 Sep 15To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 29 Sep 15
