Read e-book online Drug Discovery and Evaluation: Safety and Pharmacokinetic PDF

By Franz J. Hock (auth.), H. Gerhard Vogel Prof., Franz Jakob Hock Dr., Jochen Maas Dr., Dieter Mayer Prof. (eds.)

ISBN-10: 3540256385

ISBN-13: 9783540256380

ISBN-10: 3540298045

ISBN-13: 9783540298045

ISBN-10: 3540334424

ISBN-13: 9783540334422

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Extra info for Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays

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February, 2003 S7B Revised: The Non-clinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals. Step 3, June 2004 E14: Principles for Clinical Evaluation of New Antihypertensive Drugs. Step 3, June 2004 Draft EMEA: Guideline on the Non-Clinical Investigation of the Dependence Potential of Medicinal Products (EMEA/CHMP/SWP/94227/2004) S7B (Step 5; May 2005): EU: Adapted by CHMP May 2005, issued as CHMP/ICH/423/02. Date for coming into operation: November 2005 MHLW: To be notified FDA: Published in the Federal Register, Vol 70, No 202, pages 61134–61135; October 20, 2005 EMEA Drafts: Guideline on the Nonclinical Development of Fixed Combinations of Medicinal Product (CHMP/EMEA/CHMP/SWP/258498/2005) Guideline for the Need for Nonclinical Testing in Juvenile Animals on Human Pharmaceuticals for Pediatric Indications (EMEA/CHMP/SWP/169215/2005) FDA Draft: Safety Testing of Drug Metabolites (Guidance for Industry; June 2005) 1997 2002 2003 2004 2005 current, ICa , rapid, delayed potassium rectifying current, IKr , slow, delayed potassium rectifying current, IKs , and inward rectifying potassium current, IK1 ) and cardiac cell action potential waveforms (Hammond et al.

Hot Plate Test . . . . . . . . . . . Supplementary CNS Studies . . . Cognitive Processes . . . . . . . . Passive Avoidance Test . . . . . . Morris Maze Test . . . . . . . . . Radial Maze Test . . . . . . . . . Social Recognition Test . . . . . . Delayed Alternation Test. . . . . . EEG Studies . . . . . . . . . . . QEEG . . . . . . . . . . . . . . Sleep/Wake Cycle . . . . . . . . . Drug Dependence and Abuse. .

Possible exceptions are drug effects on CNS electrophysiology, where drug effects on cerebral cells or structures can be investigated under anesthesia. On the other hand, CNS electrophysiology can also be investigated using EEG techniques in conscious animals with higher predictability for real life situations. Core Battery CNS Safety Pharmacology Studies ICH S7A distinguishes between core battery studies and supplementary or follow-up studies. Core battery CNS procedures are typically simple tests, using traditional techniques, which can be carried out rapidly in a routine fashion.

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Drug Discovery and Evaluation: Safety and Pharmacokinetic Assays by Franz J. Hock (auth.), H. Gerhard Vogel Prof., Franz Jakob Hock Dr., Jochen Maas Dr., Dieter Mayer Prof. (eds.)

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