Drug toxicological effects

TOXLINE (non-royalty based) Toxicology Information Online National Library of Medicine 8600 Roekville Pike Bethesda, MD 20894 (301) 496-1131 On-line bibliographic database covering the pharmacological, physiological, and toxicological effects of drugs and chemicals. Information is taken from eleven secondary sources. 

Colburn, W.A. Specific antibodies and Fab fragments to alter the pharmacokinetics and reverse the pharmacological/toxicological effects of drugs. Drug Metab Rev 11(2) 223-262, 1980. 

Toxicology Test drug-treated tissue samples for toxicological effects These studies help drug companies eliminate from their pipelines - at an early stage of development - drugs that are likely to have poor side-effect profiles. This approach will make drug development more efficient and cost effective. 

Ratio impurity/drug substance and its toxicological effects... 

J. R. Gillette, Effects of induction of cytochrome P-450 enzymes on the concentration of foreign compounds and their metabolites and on the toxicological effects of these compounds. Drug Metab. Rev. 10 59 (1979). 

Description of drug substance and formulation Summaries of pharmacological and toxicological effects Summaries of pharmacokinetics and biological disposition Summary of safety and efficacy data in humans Description of possible risks and side effects. 

Toxicology, including an integrated summary of toxicological effects of the drug, including results from acute, subacute, chronic, and in vitro toxicity tests, the effects on reproduction and the fetus and special toxicity tests. A detailed tabulation of toxicity data for each study should be included. 

Immunotoxicology Evaluation of IND (PDF) (Issued October 2002, Posted October 31,2002).This guidance makes recommendations to sponsors of INDs on (1) the parameters that should be routinely assessed in toxicology studies to determine the effects of a drug on immune function (2) when additional immunotoxicity studies should be conducted and (3) when additional mechanistic information could help characterize the significance of a given drug s effect on the immune system. 

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