Matches in SemOpenAlex for { <https://semopenalex.org/work/W3082015220> ?p ?o ?g. }
Showing items 1 to 84 of
84
with 100 items per page.
- W3082015220 endingPage "1410" @default.
- W3082015220 startingPage "1401" @default.
- W3082015220 abstract "Aims Dose adjustment for drugs eliminated by the kidneys generally assume a linear relationship between renal drug clearance ( CL R ) and glomerular filtration rate ( GFR ). This assumption may not hold for drugs that undergo extensive tubular secretion where nonlinearity in drug handling is expected. The aim of this study is to determine if renal drug study designs recommended by the European Medicines Agency (EMA) and Food and Drug Administration (FDA) could distinguish linear from nonlinear renal drug handling. Methods In this simulation and estimation study, the study designs based on the EMA and FDA guidelines for Phase I renal drug studies were evaluated for their ability to discriminate a linear from a nonlinear relationship between CL R and GFR . The number of subjects for each simulated study ranged from 4 to 960. Power, relative standard error and bias were calculated. Results Study designs under the EMA and FDA guidelines required ≥8 and ≥48 subjects, respectively, to achieve ≥80% power to discriminate a linear from nonlinear relationship between CL R and GFR . The relative standard error of estimated parameters were 13–37 and 17–44% for the designs with 24 subjects under the EMA and FDA guidelines, respectively. The bias in parameter estimates under the EMA designs were not evident, however, they were biased (13–21%) under the FDA designs. Conclusion The EMA design was found to require fewer subjects ( n = 8) compared to the FDA ( n = 48) to discriminate linear from nonlinear drug renal handling at ≥80% study power while both the designs perform poorly for the parameter precision." @default.
- W3082015220 created "2020-09-08" @default.
- W3082015220 creator A5010082120 @default.
- W3082015220 creator A5037203487 @default.
- W3082015220 creator A5068008476 @default.
- W3082015220 date "2020-09-13" @default.
- W3082015220 modified "2023-09-24" @default.
- W3082015220 title "Evaluation of designs for renal drug studies based on the European Medicines Agency and Food and Drug Administration guidelines for drugs that are predominantly secreted" @default.
- W3082015220 cites W1512243736 @default.
- W3082015220 cites W1550111394 @default.
- W3082015220 cites W1930701989 @default.
- W3082015220 cites W1980716932 @default.
- W3082015220 cites W1982536422 @default.
- W3082015220 cites W2002731116 @default.
- W3082015220 cites W2003024054 @default.
- W3082015220 cites W2032303410 @default.
- W3082015220 cites W2055864845 @default.
- W3082015220 cites W2067179861 @default.
- W3082015220 cites W2068702532 @default.
- W3082015220 cites W2091740808 @default.
- W3082015220 cites W2092566765 @default.
- W3082015220 cites W2112353268 @default.
- W3082015220 cites W2114473025 @default.
- W3082015220 cites W2125832891 @default.
- W3082015220 cites W2150791618 @default.
- W3082015220 cites W2155965977 @default.
- W3082015220 cites W2466256222 @default.
- W3082015220 cites W2488685184 @default.
- W3082015220 cites W2560004549 @default.
- W3082015220 cites W2561809746 @default.
- W3082015220 cites W2607183150 @default.
- W3082015220 cites W2729565015 @default.
- W3082015220 cites W2738697628 @default.
- W3082015220 cites W2897182021 @default.
- W3082015220 cites W4242289937 @default.
- W3082015220 cites W2028499836 @default.
- W3082015220 doi "https://doi.org/10.1111/bcp.14536" @default.
- W3082015220 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/32857419" @default.
- W3082015220 hasPublicationYear "2020" @default.
- W3082015220 type Work @default.
- W3082015220 sameAs 3082015220 @default.
- W3082015220 citedByCount "2" @default.
- W3082015220 countsByYear W30820152202021 @default.
- W3082015220 countsByYear W30820152202023 @default.
- W3082015220 crossrefType "journal-article" @default.
- W3082015220 hasAuthorship W3082015220A5010082120 @default.
- W3082015220 hasAuthorship W3082015220A5037203487 @default.
- W3082015220 hasAuthorship W3082015220A5068008476 @default.
- W3082015220 hasBestOaLocation W30820152201 @default.
- W3082015220 hasConcept C126322002 @default.
- W3082015220 hasConcept C126894567 @default.
- W3082015220 hasConcept C159641895 @default.
- W3082015220 hasConcept C2780035454 @default.
- W3082015220 hasConcept C3018890749 @default.
- W3082015220 hasConcept C71924100 @default.
- W3082015220 hasConcept C98274493 @default.
- W3082015220 hasConceptScore W3082015220C126322002 @default.
- W3082015220 hasConceptScore W3082015220C126894567 @default.
- W3082015220 hasConceptScore W3082015220C159641895 @default.
- W3082015220 hasConceptScore W3082015220C2780035454 @default.
- W3082015220 hasConceptScore W3082015220C3018890749 @default.
- W3082015220 hasConceptScore W3082015220C71924100 @default.
- W3082015220 hasConceptScore W3082015220C98274493 @default.
- W3082015220 hasIssue "3" @default.
- W3082015220 hasLocation W30820152201 @default.
- W3082015220 hasOpenAccess W3082015220 @default.
- W3082015220 hasPrimaryLocation W30820152201 @default.
- W3082015220 hasRelatedWork W1973741567 @default.
- W3082015220 hasRelatedWork W2010711991 @default.
- W3082015220 hasRelatedWork W2039736044 @default.
- W3082015220 hasRelatedWork W2067628361 @default.
- W3082015220 hasRelatedWork W2093874596 @default.
- W3082015220 hasRelatedWork W2392413698 @default.
- W3082015220 hasRelatedWork W2418407361 @default.
- W3082015220 hasRelatedWork W2994250685 @default.
- W3082015220 hasRelatedWork W4296385806 @default.
- W3082015220 hasRelatedWork W4380738392 @default.
- W3082015220 hasVolume "87" @default.
- W3082015220 isParatext "false" @default.
- W3082015220 isRetracted "false" @default.
- W3082015220 magId "3082015220" @default.
- W3082015220 workType "article" @default.