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 92
Page 300
... rodent bioassays . The FDA looked at rat and mouse studies for 282 human pharmaceuticals , resulting in the conclusion that " sufficient evidence is now available for some alternative in vivo carcinogenicity models to support their ...
... rodent bioassays . The FDA looked at rat and mouse studies for 282 human pharmaceuticals , resulting in the conclusion that " sufficient evidence is now available for some alternative in vivo carcinogenicity models to support their ...
Page 595
... rodent data . In addition to rodent studies , regulatory guidelines for pharmaceuticals require that repeated dose safety studies of up to nine months ( in the United States , six months elsewhere ) in duration be conducted in a ...
... rodent data . In addition to rodent studies , regulatory guidelines for pharmaceuticals require that repeated dose safety studies of up to nine months ( in the United States , six months elsewhere ) in duration be conducted in a ...
Page 596
Shayne C. Gad. 16.2 . COMPARISON BETWEEN RODENT AND NONRODENT EXPERIMENTAL DESIGN 16.2.1 . Number of Animals One of the main differences in experimental design between rodent and nonrodent safety studies is the number of animals used ...
Shayne C. Gad. 16.2 . COMPARISON BETWEEN RODENT AND NONRODENT EXPERIMENTAL DESIGN 16.2.1 . Number of Animals One of the main differences in experimental design between rodent and nonrodent safety studies is the number of animals used ...
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