By Franz J. Hock (auth.), H. Gerhard Vogel Prof., Franz Jakob Hock Dr., Jochen Maas Dr., Dieter Mayer Prof. (eds.)
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Extra info for Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays
Sample text
It first appeared in drafts of the ICH guidelines “Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals”, Topic M3, and “Preclinical Safety Evaluation of Biotechnologyderived Pharmaceuticals”, Topic S6 (see Table 3). , cardiovascular, respiratory, renal, and central nervous system)”. The ICH Topic S7 Expert Working Group began their work in the first quarter of 1999, and a harmonized safety pharmacology guideline was finalized and adopted by the regional regulatory authorities over 2000–2001 (ICH S7A).
Hock The adverse effects of new drug entities in animals and humans can be manifested by changes in the structural, biochemical or physiological status of the organism. In the preclinical safety assessment process, toxicological procedures have traditionally focused on the structural and biochemical consequences of drug actions. As a result, there has been a reliance on histopathological evaluation of organs and clinical pathology measures in the toxicological assessment of new drug candidates.
Radial Maze Test . . . . . . . . . Social Recognition Test . . . . . . Delayed Alternation Test. . . . . . EEG Studies . . . . . . . . . . . QEEG . . . . . . . . . . . . . . Sleep/Wake Cycle . . . . . . . . . Drug Dependence and Abuse. . . . Drug Dependence . . . . . . . . . Non-Precipitated Withdrawal Test . Drug Abuse . . . . . . . . . . . . Conditioned Place Preference Test . Drug Discrimination .