Drug Safety EvaluationWiley, 2002 M04 18 - 1007 pages A comprehensive safety guide to all aspects of the drug development process Drug Safety Evaluation presents an all-inclusive, practical guide for those who are responsible for ensuring the safety of drugs and biologics for patients, for health care providers, for those involved in the manufacture of medicinal products, and for all those who need to understand how the safety of these products is evaluated. Individual chapters address specific approaches to evaluating hazards, including problems that are encountered and their solutions. Author Shayne Gad draws upon over twenty years of experience in toxicology, drug development, and risk assessment, explaining the scientific and philosophical bases for evaluating specific concerns (carcinogenicity, development toxicity, etc.) to provide both understanding and guidance for approaching new problems. Containing information specifically relevant to the pharmaceutical and biotechnology industries, Drug Safety Evaluation covers a wide variety of topics, including: * Acute toxicity testing in pharmaceutical safety evaluation * Genotoxicity * Safety assessment of inhalant drugs * Immunotoxicology in pharmaceutical development * Large animal studies * Evaluation of human tolerance and safety in clinical trials Drug Safety Evaluation provides a road map for safety assessment as an integral part of the development of new drugs and therapeutics. |
From inside the book
Results 1-3 of 73
Page 16
... compounds . The frequency is related to the probability of discovery and to the degree of risk ( hazard to health ) associated with an active compound passing a screen undetected . These two factors in turn depend on the distribution of ...
... compounds . The frequency is related to the probability of discovery and to the degree of risk ( hazard to health ) associated with an active compound passing a screen undetected . These two factors in turn depend on the distribution of ...
Page 115
... compounds will be tested . It is unlikely that one will stand out so much as to have greater statistical significance than all the other compounds ( Bergman and Gittins , 1985 ) . A more or less continuous range of activities will be ...
... compounds will be tested . It is unlikely that one will stand out so much as to have greater statistical significance than all the other compounds ( Bergman and Gittins , 1985 ) . A more or less continuous range of activities will be ...
Page 120
... compound meets this criterion , the compound is " active " and handled accord- ingly . Such a criterion could have a statistical basis ( e.g. , all compounds with observed activities significantly greater than the control at the 5 ...
... compound meets this criterion , the compound is " active " and handled accord- ingly . Such a criterion could have a statistical basis ( e.g. , all compounds with observed activities significantly greater than the control at the 5 ...
Contents
Regulation of Human Pharmaceutical Safety | 30 |
Building and Maintaining Data | 99 |
Screens in Safety and Hazard Assessment | 112 |
Copyright | |
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Common terms and phrases
absorption activity administration adverse aerosols agents analysis and/or antibody antigen appropriate assay biological blood body weight carcinogenicity carcinogenicity studies cells chemical chromosome clinical trials concentration culture dermal detect determine developmental toxicity disease dosage drug effects endpoints evaluation example excipients exposure factors function gene genotoxicity guidelines hepatocytes human immune immunotoxicity increase inhalation injection irritation laboratory lethality liver macrophages measure metabolism metabolites methods mice minipigs molecules monoclonal antibodies mouse mutagenicity mutation nonrodent normal number of animals observed oral organ parameters patients pharmaceutical pharmacokinetic pharmacological Phase plasma potential preclinical protein protocol rabbits rats regulations regulatory renal response rodent route route of administration safety assessment sample screen selection sensitivity significant skin specific statistical substance Table techniques teratogenicity Teratology test article therapeutic tissue toxicity toxicity studies toxicity testing Toxicol toxicology treatment tumor variables vitro vivo xenobiotic