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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
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| Cham : , : Springer International Publishing : , : Imprint : Adis, , 2017 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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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 |
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Turner J. Rick
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| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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