Safety aspects have become an outstanding issue in the process of drug discovery and development. Until 15 years ago, drug discovery and evaluation was a sequential process starting with the selection of the most active compound from a series of newly synthesized compounds by means of special pharmacological assays.
This book is a landmark in the continuously changing world of drugs. As such it is important reading for many groups: not only for all students of pharmacology and toxicology but also for physicians, especially those involved in clinical trials of drugs, and for pharmacists who have to know the safety requirements of drugs.
The book is absolutely essential for scientists and managers in the pharmaceutical industry who are involved in drug finding, drug development and decision making in the development process.
In particular, the book will be of use for government institutions and committees working on official guidelines for drug evaluation worldwide.
General Introduction: Section I Safety Pharmacology: Introduction for Section I Safety Pharmacology.- Status of Safety Pharmacology and present Guidelines.- Central Nervous System Safety Pharmacology Studies.- Methods in Cardiovascular Safety Pharmacology.- Safety Pharmacology for Renal System Drugs.- Respiratory Function Assays in Safety Pharmacology.- Safety Tests in Metabolism Pharmacology.- Safety Pharmacology in Peripheral Nervous System Drugs.- Safety Pharmacology for Intravenous and Inhalation Anesthetics.- Side effects of central analgesic drugs.- Safety Pharmacology of Anti-inflammatory drugs.- Safety Pharmacology of Drugs with Osteoarthritis-related activity.- Safety Pharmacology of Blood Constituents.- Safety Assessment of Drugs Used in Ophthalmology.- Safety Assays in Endocrine Pharmacology.- Safety Assays in Skin Pharmacology.- Safety Pharmacology in Biologics.- Magnetic Resonance Imaging in Pharmaceutical Safety Assessment.- Perspectives of Safety Pharmacology, Ongoing Initiatives and Activities, Pharmaceuticals in the Environment.- Section II Safety Pharmacokinetics: Introduction.- Absorption-ex vivo tests.- Absorption-in vitro tests-cell based.- Absorption-in vitro tests-non cell based.- Absorption-in vivo tests (radiolabeled).- Bioanalytical assays-GC.- Bioanalytical assays-LC-MS/MS.- Bioanalytical assays-RIA/ELISA.- Bioanalytical assays-Toxicokinetics.- Clinical studies—typical designs.- Distribution-across barriers.- Distribution-in vitro tests-protein binding.- Distribution-in vivo-other methods.- Distribution-in vivo-perfused organs.- Distribution-in vivo-QWBA.- Drug-drug interaction-enzyme induction.- Drug-drug interaction-enzyme inhibition.- In-silico ADME Modeling.- Metabolism-enzyme mapping.- Metabolism-in vitro stability/profiling.- Metabolism-in vivo profiling.- Pharmacogenomics in DME.- Physicochemical properties.- Population kinetics.- Typical PK/PD approaches.- Section III Safety toxicology: Introduction.- International Guidelines.- General toxicity (acute, subchronic, chronic, carcinogenicity).- In silico methods.- Alternative methods for carcinogenicity testing.- Drug Addiction in monkeys.- Genotoxicity.- Pathology.- Reproductive Toxicology.- Toxicogenomics.- Toxicoproteomics