Cardiovascular Safety In Drug Development And Therapeutic Use: New Methodologies And Evolving Regulatory Landscapes
by J. Rick Turner /
2016 / English / PDF
3.7 MB Download
At a time when the field of cardiac safety is going through
important changes, this unique book provides the rationale for,
and cutting-edge explanations of, new regulatory landscapes that
will likely govern cardiac safety assessments globally for the
foreseeable future. Exposure-response modeling is already
being accepted by regulatory agencies in lieu of the traditional
Thorough QT/QTc Study, and the Comprehensive
At a time when the field of cardiac safety is going through
important changes, this unique book provides the rationale for,
and cutting-edge explanations of, new regulatory landscapes that
will likely govern cardiac safety assessments globally for the
foreseeable future. Exposure-response modeling is already
being accepted by regulatory agencies in lieu of the traditional
Thorough QT/QTc Study, and the Comprehensivein
vitro
in
vitroProarrhythmia Assay initiative is well under way.
Proarrhythmia Assay initiative is well under way.Developments in the field of cardiovascular safety are also
described and discussed in the book. These include the search
for more efficient ways to exonerate new drugs for type 2 diabetes
from an unacceptable cardiovascular liability, how best to address
off-target blood pressure increases induced by noncardiovascular
drugs, and the continued evolution of the discipline of
Cardio-oncology.
Developments in the field of cardiovascular safety are also
described and discussed in the book. These include the search
for more efficient ways to exonerate new drugs for type 2 diabetes
from an unacceptable cardiovascular liability, how best to address
off-target blood pressure increases induced by noncardiovascular
drugs, and the continued evolution of the discipline of
Cardio-oncology.
“a resource that will likely serve as a standard for years to
come”
“a resource that will likely serve as a standard for years to
come”
- Dr Jonathan Seltzer
- Dr Jonathan SeltzerTherapeutic Innovation & Regulatory Science
Therapeutic Innovation & Regulatory Science,
2017;51(2):180
,
2017;51(2):180
“I have no hesitation in recommending this book as a valuable
reference source”
“I have no hesitation in recommending this book as a valuable
reference source”
- Dr Rashmi Shah
- Dr Rashmi ShahJournal for Clinical Studies
Journal for Clinical Studies, 2017;9(1):62-63
, 2017;9(1):62-63
