Analysis of Drug-Drug Interaction Labeling Language and Clinical Recommendations for Newly Approved Drugs Evaluated With Digoxin, Midazolam, and S-Warfarin was written by Henderson, Lindsay M.;Steinbronn, Claire E.;Yu, Jingjing;Yeung, Catherine K.;Ragueneau-Majlessi, Isabelle. And the article was included in Clinical Therapeutics in 2021.Reference of 1211441-98-3 This article mentions the following:
To best promote drug tolerability and efficacy in the clinic, data from drug-drug interaction (DDI) evaluations and subsequent translation of the results to DDI prevention and/or management strategies must be incorporated into the US Food and Drug Administration (FDA) product labeling in a consistent manner because differences in language might result in varied interpretations. This anal. aimed to assess the consistency in DDI labeling language in New Drug Applications (NDAs). NDAs of recently approved drugs (2012-2020) that increase the exposure of digoxin, midazolam, and S-warfarin, index substrates of P-glycoprotein, cytochrome P 450 (CYP) 3A, and CYP2C9 activity, resp., were fully reviewed. Noninhibitors were also evaluated to appreciate the extent of mechanistic extrapolation in case of neg. index studies. After a systematic review of the DDI studies available in NDAs, FDA-approved labeling, and commonly used clin. tertiary resources, differences in DDI results presentation and resulting clin. recommendations were found, even for inhibitors that affect similarly the exposure of the same index substrate. Studies with neg. results were often reported in the labels without providing mechanistic interpretation, thus limiting the possible extrapolation of this information to other known substrates. The variability in language affects how the information was presented to clinicians in tertiary resources. Strategies that aim to improve the translation of mechanistic DDI index studies into consistent labeling recommendations are briefly discussed in this review. In the experiment, the researchers used many compounds, for example, 7-Cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (cas: 1211441-98-3Reference of 1211441-98-3).
7-Cyclopentyl-N,N-dimethyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide (cas: 1211441-98-3) belongs to piperazine derivatives. Piperazine is a fairly basic compound and is an amine solvent. Piperazine and its salts did not induce point mutations in a bacterial test. A series of mutagenicity studies in cells, both in vitro and in vivo, has been completed and showed no evidence of mutagenic effect.Reference of 1211441-98-3
Referemce:
Piperazine – Wikipedia,
Piperazines – an overview | ScienceDirect Topics