Cardiovascular Safety in Drug Development and Therapeutic Use
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Cardiovascular Safety in Drug Development and Therapeutic Use
New Methodologies and Evolving Regulatory Landscapes
Turner, J. Rick; Kothari, Snehal; Karnad, Dilip R.
Springer International Publishing AG
06/2018
342
Mole
Inglês
9783319820859
15 a 20 dias
757
Descrição não disponível.
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.
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Proarrhythmic liability;QT interval prolongation;hERG channel blockade;Thorough QT/QTc Study;Regulatory science;Exposure-response modeling;CiPA;Cardio-oncology;Type 2 diabetes;Meta-analysis;Postmarketing surveillance;Reporting clinical trials
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.
Este título pertence ao(s) assunto(s) indicados(s). Para ver outros títulos clique no assunto desejado.
