1.

Record Nr.

UNINA9910144409203321

Autore

Turner J. Rick

Titolo

Integrated cardiac safety : assessment methodologies for noncardiac drugs in discovery, development, and postmarketing surveillance / / J. Rick Turner, Todd A. Durham

Pubbl/distr/stampa

Hoboken, N.J., : John Wiley & Sons, c2009

ISBN

1-282-00206-6

9786612002069

0-470-41129-5

0-470-41128-7

Edizione

[1st ed.]

Descrizione fisica

1 online resource (500 p.)

Altri autori (Persone)

DurhamTodd A

Disciplina

616.1/23061

Soggetti

Cardiovascular toxicology

Heart - Effect of drugs on

Drugs - Side effects - Testing

Drugs - Safety measures

Lingua di pubblicazione

Inglese

Formato

Materiale a stampa

Livello bibliografico

Monografia

Note generali

Description based upon print version of record.

Nota di bibliografia

Includes bibliographical references (p. 397-455) and index.

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.

Sommario/riassunto

The serious nature of cardiovascular adverse drug reactions occurring in patients makes assessment of a drug's cardiac safety profile a high priority during both development and post-approval monitoring. Integrated Cardiac Safety provides necessary guidance and methodology for professionals assessing cardiac safety of drugs throughout all stages of the drug's life, from discovery and development through postmarketing research. This self-contained,



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