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Cardiovascular Safety in Drug Development and Therapeutic Use : New Methodologies and Evolving Regulatory Landscapes / / by J. Rick Turner, Dilip R. Karnad, Snehal Kothari
Cardiovascular Safety in Drug Development and Therapeutic Use : New Methodologies and Evolving Regulatory Landscapes / / by J. Rick Turner, Dilip R. Karnad, Snehal Kothari
Autore Turner J. Rick
Edizione [1st ed. 2017.]
Pubbl/distr/stampa Cham : , : Springer International Publishing : , : Imprint : Adis, , 2017
Descrizione fisica 1 online resource (XXVI, 333 p. 2 illus. in color.)
Disciplina 353.998
Soggetto topico Pharmacy
Cardiology
Drug Safety and Pharmacovigilance
ISBN 3-319-40347-8
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto The Central Importance of Cardiovascular Safety in Contemporary New Drug Development -- The Biological Basis of Drug Responses -- Cardiovascular Structure, Function, Pathophysiology, & Disease -- The Current Regulatory Landscape -- The "Comprehensive In Vitro Proarrhythmia Assay" Initiative -- The "Early ECG Assessment" Initiative -- The "Submission of Extended Digital ECG Data" Initiative -- Meta-analysis and Meta-methodology -- Current Regulatory Landscapes and their Potential Evolution -- Off-target Blood Pressure Responses to Non-cardiovascular Drugs -- Oncology Drug Development and Therapeutics: Cardiotoxicity Considerations -- Postmarketing Surveillance -- Regulatory Perspectives on General Drug Safety -- Future Directions in Cardiovascular Safety -- References.
Record Nr. UNINA-9910254496803321
Turner J. Rick  
Cham : , : Springer International Publishing : , : Imprint : Adis, , 2017
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui
Integrated cardiac safety : assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance / / J. Rick Turner, Todd A. Durham
Integrated cardiac safety : assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance / / J. Rick Turner, Todd A. Durham
Autore Turner J. Rick
Edizione [1st ed.]
Pubbl/distr/stampa Hoboken, N.J., : John Wiley & Sons, c2009
Descrizione fisica 1 online resource (500 p.)
Disciplina 616.1/23061
Altri autori (Persone) DurhamTodd A
Soggetto topico Cardiovascular toxicology
Heart - Effect of drugs on
Drugs - Side effects - Testing
Drugs - Safety measures
ISBN 1-282-00206-6
9786612002069
0-470-41129-5
0-470-41128-7
Formato Materiale a stampa
Livello bibliografico Monografia
Lingua di pubblicazione eng
Nota di contenuto The importance of cardiac safety assessments -- The biological basis of adverse drug reactions -- Cardiac structure and function -- Cardiac pathophysiology and disease -- Drug discovery and drug design -- Nonclinical development -- The thorough QT/QTc trial -- General safety assessments -- Therapeutic use trials and meta-analyses -- Assessment methodologies in nonexperimental postmarketing surveillance -- Postmarketing proarrhythmic cardiac safety assessments -- Generalized cardiac safety -- Medication errors, adherence, and concordance -- Future directions in drug safety.
Record Nr. UNINA-9910144409203321
Turner J. Rick  
Hoboken, N.J., : John Wiley & Sons, c2009
Materiale a stampa
Lo trovi qui: Univ. Federico II
Opac: Controlla la disponibilità qui