Titlebook: Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays; Franz J. Hock,Michael K. Pugsley Reference work 2024Latest edition Sprin

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays978-3-031-35529-5

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Status of Safety Pharmacology and Present Guidelinesin detail. A detailed guideline development after the more frequently observed QT-time prolongation is also described. The different strategies prior to the implementation of the ICH Guidelines are also discussed.

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Overview of the ICH E14/S7B: Questions and Answerstes (TdP) has remained a significant burden in pharmaceutical drug development, leading to drug withdrawal from the marketplace and late-stage attrition in research and development. This chapter provides an overview of the regulatory guidance that emerged to address this issue with an emphasis on th

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Central Nervous System (CNS) Safety Pharmacology Studiesrvous system (CNS) is one of the vital systems which need to be protected against the potential harmful effects of test items. The present chapter includes some guidance for the selection and the realization of preclinical tests used in the context of CNS safety pharmacology. In contrast with a tren

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In Vivo Methods in Cardiovascular Safety Pharmacologyon the heart and peripheral vasculature as well as assess any other effect that may secondarily lead to an activation or depression of cardiovascular performance. According to the cardiovascular SP guidelines, telemetry studies in conscious large animals are preferred for evaluation of drug-induced