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. |
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Results 1-3 of 69
Page 75
... Table 2.11 . So far , ICH has proposed or adopted over 40 safety , efficacy , and quality guidelines ( listed in Table 2.12 ) for use by the drug- TABLE 2.11 . Steps in ICH Guideline Development and Implementation Step Action 2 12 345 ...
... Table 2.11 . So far , ICH has proposed or adopted over 40 safety , efficacy , and quality guidelines ( listed in Table 2.12 ) for use by the drug- TABLE 2.11 . Steps in ICH Guideline Development and Implementation Step Action 2 12 345 ...
Page 491
... Table 13.11 . These are sufficient , however , only for those excipients intended for use for up to two weeks in humans . If exposure to the new pharmaceutical excipient is expected to occur for longer than two but no more than six ...
... Table 13.11 . These are sufficient , however , only for those excipients intended for use for up to two weeks in humans . If exposure to the new pharmaceutical excipient is expected to occur for longer than two but no more than six ...
Page 926
... table . The probability table is set up as before except that instead of multiplying the appropriate table values by SEM , SEM2 is used . This is equal to MSwg - For the desired comparison of two groups at a time , either the ( 772 ) ...
... table . The probability table is set up as before except that instead of multiplying the appropriate table values by SEM , SEM2 is used . This is equal to MSwg - For the desired comparison of two groups at a time , either the ( 772 ) ...
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