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)
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.