By Guofeng You, Marilyn E. Morris, Binghe Wang

Drug-Drug Interactions in Pharmaceutical improvement comprehensively experiences the correct technology, commercial perform, and regulatory organization positions on drug-drug interactions. It makes a speciality of the evaluate of strength drug-drug interactions, permitting researchers to deal with danger components earlier than a drug is placed to industry. The ebook covers either medical and nonclinical facets for realizing drug-drug interactions in addition to in vitro and in vivo reviews to be used in learning interactions on the drug discovery degree.

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Additional info for Drug-Drug Interactions in Pharmaceutical Development (Wiley Series in Drug Discovery and Development)

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As of now, there are no examples of in vivo enzyme inhibitors that are not inhibitors in vitro. Significant inhibition observed: A practical definition of significant inhibition is that the test article is found to cause dose-dependent and >50% inhibition of one or more P450 isoforms at the concentrations evaluated. The conclusion is that the test article is a potent inhibitor. 1 or higher as possible or likely to cause in vivo drug–drug interactions. It is recommended that [I]/Ki values obtained from cell-free systems (microsomes and rCYP) are confirmed by that with intact hepatocytes to aid an accurate prediction of in vivo effects.

For mechanism-based inhibitors, Kinact is estimated by an experiment with varying inhibitor concentration and preincubation time. A typical Kinact study is as follows: . In vitro experimental system: rCYP; human liver microsomes, or hepatocytes. , 5, 10, 15, 20, and 30 min). Inhibitor concentration: 5 (ideally yielding 10–90% inhibition of activity). Substrate concentration: 1. , 5, 10, and 15 min) if time course under the experimental conditions has not been established. Kinact is determined by the following approach: – Plot activity as a percent of the solvent control versus time.

Br J Clin Pharmacol 1999;48:733–742. Li AP, Lu C, Brent JA, Pham C, Fackett A, Ruegg CE, Silber PM. Cryopreserved human hepatocytes: characterization of drug-metabolizing enzyme activities and applications in higher throughput screening assays for hepatotoxicity, metabolic stability, and drug–drug interaction potential. Chem Biol Interact 1999b;121: 17– 35. Li AP, Maurel P, Gomez-Lechon MJ, Cheng LC, Jurima-Romet M. Applications of primary human hepatocytes in the evaluation of P450 induction. Chem Biol Interact 1997;107:5–16.

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