Cardiovascular Safety in Drug Development and Therapeutic Use

New Methodologies and Evolving Regulatory Landscapes

Nonfiction, Health & Well Being, Medical, Medical Science, Pharmacology, Specialties, Internal Medicine, Cardiology
Cover of the book Cardiovascular Safety in Drug Development and Therapeutic Use by J. Rick Turner, Dilip R. Karnad, Snehal Kothari, Springer International Publishing
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Author: J. Rick Turner, Dilip R. Karnad, Snehal Kothari ISBN: 9783319403472
Publisher: Springer International Publishing Publication: July 28, 2016
Imprint: Adis Language: English
Author: J. Rick Turner, Dilip R. Karnad, Snehal Kothari
ISBN: 9783319403472
Publisher: Springer International Publishing
Publication: July 28, 2016
Imprint: Adis
Language: English

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 *in vitro *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.

“a resource that will likely serve as a standard for years to come” 

- Dr Jonathan Seltzer

Therapeutic Innovation & Regulatory Science, 2017;51(2):180

“I have no hesitation in recommending this book as a valuable reference source” 

- Dr Rashmi Shah

Journal for Clinical Studies, 2017;9(1):62-63

View on Amazon View on AbeBooks View on Kobo View on B.Depository View on eBay View on Walmart

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 *in vitro *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.

“a resource that will likely serve as a standard for years to come” 

- Dr Jonathan Seltzer

Therapeutic Innovation & Regulatory Science, 2017;51(2):180

“I have no hesitation in recommending this book as a valuable reference source” 

- Dr Rashmi Shah

Journal for Clinical Studies, 2017;9(1):62-63

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