(Q47773717)

5 February 2018

title

Methodology used in safety pharmacology: appraisal of the state-of-the-art, the regulatory issues and new directions (English)

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5 February 2018

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Michael K Pugsley

1

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5 February 2018

publication date

1 July 2005

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5 February 2018

Journal of Pharmacological and Toxicological Methods

published in

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5 February 2018

volume

52

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5 February 2018

issue

1

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5 February 2018

page(s)

1-5

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5 February 2018

Origins, practices and future of safety pharmacology

cites work

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Drugs effects on ventricular repolarization: a critical evaluation of the strengths and weaknesses of current methodologies and regulatory practices

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ICH S7B draft guideline on the non-clinical strategy for testing delayed cardiac repolarisation risk of drugs: a critical analysis

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Additive effects of ziprasidone and D,L-sotalol on the action potential in rabbit Purkinje fibres and on the hERG potassium current

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Assessment of renal injury in vivo

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Non-clinical evaluation of ventricular repolarization (ICH S7B): results of an interim survey of international pharmaceutical companies

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Automated electrophysiology in the preclinical evaluation of drugs for potential QT prolongation

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Respiratory function in rats restrained for extended periods: assessment of the effects of bethanecol

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Gastrointestinal-tract models and techniques for use in safety pharmacology.

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Cardiovascular parameters in anaesthetized guinea pigs: a safety pharmacology screening model

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New preclinical guidelines on drug effects on ventricular repolarization: safety pharmacology comes of age.

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Nonclinical proarrhythmia models: predicting Torsades de Pointes

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Choice of cardiac tissue plays an important role in the evaluation of drug-induced prolongation of the QT interval in vitro in rabbit

7 January 2021

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Effects of fasting on evaluation of gastrointestinal transit with charcoal meal

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Validation of a motor activity system by a robotically controlled vehicle and using standard reference compounds

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Safety pharmacology matures into a unique pharmacological discipline

7 January 2021

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Spectrum of effects detected in the rat functional observational battery following oral administration of non-CNS targeted compounds

7 January 2021

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Relationship between prolongation of QTc and prolongation of the peak of T (Tp) to the end of T (Te)

7 January 2021

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Evaluation of cardiac function in primates using real-time three-dimensional echocardiography as applications to safety assessment

7 January 2021

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Challenges and lessons learned since implementation of the safety pharmacology guidance ICH S7A.

7 January 2021

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A new method to calculate the beat-to-beat instability of QT duration in drug-induced long QT in anesthetized dogs

7 January 2021

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HERG-Lite: a novel comprehensive high-throughput screen for drug-induced hERG risk

7 January 2021

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Estimation of potency of HERG channel blockers: impact of voltage protocol and temperature

7 January 2021

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10.1016/J.VASCN.2005.05.002

7 January 2021

Identifiers

DOI

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5 February 2018

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5 February 2018