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

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ribed with subsequent considerations relevant for developing an integrated risk assessment considering the early phase I clinical data. In addition, current challenges and future directions of the regulatory process are discussed.

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ictive values, etc. Currently available, systematic translation analyses for safety pharmacology studies are also discussed. Overall, robust data is available for establishing translation of cardiovascular assays, especially assays for assessing the risk of delayed ventricular repolarization, QT pro

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y studies is that they are performed under unstressed and physiological conditions. Despite the preference for the use of conscious animals, SP studies are also performed using anesthetized animal models. Anesthetized animal studies allow for a more in-depth evaluation of possible drug effects on th

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jury potential. We present pharmacological methods aiming to elucidate the potential undesirable effect of compounds on intermediary carbohydrate and lipid metabolism resulting in hypo- or hyperglycemia, hyperlipidemia, and insulin resistance, which can ultimately provoke life-threatening hypoglycem

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