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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Page 141
... Lethality Data in Drug Development : The Minimum Lethal Dosage Range - finding data are often used early in drug development to make preliminary safety estimates . The LD50 is simply a calculated point on a curve . The shape or slope of ...
... Lethality Data in Drug Development : The Minimum Lethal Dosage Range - finding data are often used early in drug development to make preliminary safety estimates . The LD50 is simply a calculated point on a curve . The shape or slope of ...
Page 144
... lethality , there is seldom any need to include control animals . If the projected human dosage is 4 mg kg ' , for example , the initial dosage in an MLD range finder in dogs will be 20 mg kg and succeeding dosages will increase ...
... lethality , there is seldom any need to include control animals . If the projected human dosage is 4 mg kg ' , for example , the initial dosage in an MLD range finder in dogs will be 20 mg kg and succeeding dosages will increase ...
Page 147
... lethality testing : 1. There is little to be gained from testing dosages that are so high that the physical rather ... lethality . Because it is rare that an extensive acute protocol would be attempted without preliminary lethality data ...
... lethality testing : 1. There is little to be gained from testing dosages that are so high that the physical rather ... lethality . Because it is rare that an extensive acute protocol would be attempted without preliminary lethality data ...
Contents
Regulation of Human Pharmaceutical Safety | 30 |
Building and Maintaining Data | 99 |
Screens in Safety and Hazard Assessment | 112 |
Copyright | |
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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