Toxicity pharmacokinetics

A review discussing anthelmintic activity, pharmacokinetics, toxicity, side effects, and clinical use of niclosamide and other anthelmintic agents is reported [95],... 

Part IC2 contains an expert report on the toxicopharmacological (preclini-cal) documentation. Topics presented include pharmacodynamics, pharmacokinetics, toxicity, and information on the preclinical expert. An example is given in Exhibit 8.6. 

Zhu G, Oto E, Vaage J, et al. The effect of vincristine-polyanion complexes in STEALTH liposomes on pharmacokinetics, toxicity and anti tumor activity. Cancer Chemother Pharmacol 1996 39 138. 

Subclass Mechanism of Action Effects Clinical Applications Pharmacokinetics, Toxicities, Interactions... 

Vermes A, Guchelaar HJ, Dankert J. Flucytosine a review of its pharmacology, clinical indications, pharmacokinetics, toxicity, and drug interactions. J Antimi-crob Chemother. 2000 46 171-179. 

Relevance, an assurance that the compounds have properties that make them sufficiently drug-like to have, in the event of activity being found, a low probability of unacceptable pharmacokinetics, toxicity, or other undesired trait. 

With a compound discovery method in place that achieves high potency and specificity, all that remains for aptamers to have utility as drugs would be stability, pharmacokinetics, toxicity, and low immunogenicity of aptamers in vivo. Because the literature was clear about the major human plasma endonucleases that destroy RNA molecules, one early event in the NeXstar... 

Gokhale, PC., Zhang, C., Newsome, J., Pei, J., Ahmad, I., Rahman, A., Dritschilo, A., and Kasid, U. (2002) Pharmacokinetics, toxicity, and efficacy of ends-modified raf antisense oligodeoxyribonucleotide encapsulated in a novel cationic liposome (LErafAON). Clin. Cancer Res. 8, 3611-3621. 

Outside the EEC, the Swiss regulatory agency (Interkantonale Kon-trollstelle fur Heilmittel) has issued a brief statement on its approach to evaluating submissions on chiral drugs. The Swiss state that, for a mixture of isomers, data for each component should be available on the respective pharmacodynamics, pharmacokinetics, toxicity, and metabolism. Pharmacokinetic data, based on nonspecific analytical methods, wiU be assessed very critically. For pure isomers, other isomers, if present, are regarded as impurities. A new application fora pure isomer of a substance that is already registered as a racemate will be treated as an NCE application. 

Cyp2C8 Taxol Reduced metabolism Altered pharmacokinetics, toxicity... 

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