From 1e73708fbe263d17a31ae454ced5b2ca137e6d1d Mon Sep 17 00:00:00 2001 From: Thomas Wendl Date: Fri, 20 Sep 2024 15:50:12 +0200 Subject: [PATCH 1/2] Update Digoxin-Model.json --- Digoxin-Model.json | 20755 +++++++++++++++++++++++++++++-------------- 1 file changed, 14103 insertions(+), 6652 deletions(-) diff --git a/Digoxin-Model.json b/Digoxin-Model.json index 395932e..81f8ba3 100644 --- a/Digoxin-Model.json +++ b/Digoxin-Model.json @@ -1830,6 +1830,28 @@ "Unit": "ml/kg" } ] + }, + { + "Name": "Digoxin po, Gurley '06, 0.4 mg", + "ApplicationType": "Oral", + "DosingInterval": "Single", + "Parameters": [ + { + "Name": "Start time", + "Value": 0.0, + "Unit": "h" + }, + { + "Name": "InputDose", + "Value": 0.4, + "Unit": "mg" + }, + { + "Name": "Volume of water/body weight", + "Value": 3.5, + "Unit": "ml/kg" + } + ] } ], "Simulations": [ @@ -1838,7 +1860,10 @@ "Model": "4Comp", "ObservedData": [ "Eckermann 2012 - 0.25mg po - Digoxin - PO - 250 µg - Plasma - agg. 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(n=10)" ] }, { "Name": "0,25 / 0,5 mg", "Classifiables": [ - "Sanofi-Aventis 2009 - 0.25mg md QD - Digoxin - PO - 0,25 / 0,5 mg - Plasma - agg. (n=20)", - "Sanofi-Aventis 2009 - 0.25mg md QD with dronedarone 400mg bid - Digoxin - PO - 0,25 / 0,5 mg - Plasma - agg. (n=20)", - "Kirch 1986 - 2x0.25mg po md with nifedipine - Digoxin - PO - 0,25 / 0,5 mg - Plasma - agg. (n=7)" + "Sanofi-Aventis 2009 - 0.25mg md QD - Digoxin - PO - 0,25 / 0,5 mg - Plasma - agg. (n=20)" ] }, { "Name": "0.25 mg", "Classifiables": [ + "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", "Eckermann 2012 - 0.25mg po - Digoxin - PO - 250 µg - Plasma - agg. (n=16)", "Friedrich 2011 - 0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=20)", "Johne 1999 - 0.25mg po md with placebo day 6 - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", "Johne 1999 - 0.25mg po md with placebo day 15 - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", "Kirch 1986 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=7)", - "Vaidyanathan 2008 - 0.25mg po pd - Digoxin - PO - 0.25 mg - Plasma - agg. (n=22)", - "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", - "Gurley 2008b - with Perpetrator (Rifampicin) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", - "Gurley 2008b - with Perpetrator (Clarithomycin) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", - "Eckermann 2012 - 0.25mg po with roflumilast - Digoxin - PO - 250 µg - Plasma - agg. (n=16)", - "Friedrich 2011 - 0.25mg po md with linagliptin - Digoxin - PO - 0.25 mg - Plasma - agg. (n=20)", "Rodin 1988 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=10)", - "Rodin 1988 - 2x0.25mg po md with verapamil - Digoxin - PO - 0.25 mg - Plasma - agg. (n=10)", - "Rodin 1988 - 2x0.25mg po md with isradipine - Digoxin - PO - 0.25 mg - Plasma - agg. (n=9)", - "Vaidyanathan 2008 - 0.25mg po pd with aliskiren - Digoxin - PO - 0.25 mg - Plasma - agg. (n=22)", - "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", - "Gurley 2008 - with Perpetrator (Echinacea) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", - "Gurley 2008 - with Perpetrator (St. John's wort) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)" + "Vaidyanathan 2008 - 0.25mg po pd - Digoxin - PO - 0.25 mg - Plasma - agg. (n=22)" ] }, { "Name": "0.5 mg", "Classifiables": [ - "Verstuyft 2003 - 0.5mg with Placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", - "Verstuyft 2003 - 0.5mg with placebo - Digoxin - PO - 0.5 mg - Urine - agg. (n=12)", - "Tayrouz 2003 - 0.5mg po with placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", - "Westphal 2000 - 0.5mg po - Digoxin - PO - 0.5 mg - Plasma - agg. (n=10)", "Jalava 1997 - po Control (Perpetrator Placebo) - Digoxin - PO - 0.5 mg - Serum - agg. (n=10)", - "Jalava 1997 - po with Perpetrator (Itraconazole) - Digoxin - PO - 0.5 mg - Serum - agg. (n=10)", "Jalava 1997 - po Control (Perpetrator Placebo) - Digoxin - PO - 0.5 mg - Urine - agg. (n=10)", - "Jalava 1997 - po with Perpetrator (Itraconazole) - Digoxin - PO - 0.5 mg - Urine - agg. (n=10)", "Kirby 2012 - Study 1 - Staggered Administration Control - Digoxin - PO - 0.5 mg - Plasma - agg. (n=16)", - "Kirby 2012 - Study 1 - Staggered Administration with RIF - Digoxin - PO - 0.5 mg - Plasma - agg. (n=16)", "Kirby 2012 - Study 2 - Simultaneous Administration Control - Digoxin - PO - 0.5 mg - Plasma - agg. (n=9)", - "Kirby 2012 - Study 2 - Simultaneous Administration with RIF - Digoxin - PO - 0.5 mg - Plasma - agg. (n=9)", "Larsen 2007 - Control (Perpetrator Placebo) - Digoxin - PO - 0.5 mg - Serum - typical (n=10)", - "Larsen 2007 - with Perpetrator (Rifampicin) - Digoxin - PO - 0.5 mg - Serum - typical (n=10)", - "Larsen 2007 - with Perpetrator (Ketoconazole) - Digoxin - PO - 0.5 mg - Serum - typical (n=10)", - "Reitman 2011 - Week 0 after Perpetrator (Rifampicin) - Digoxin - PO - 0.5 mg - Plasma - agg. (n=11)", - "Reitman 2011 - Week 1 after Perpetrator (Rifampicin) - Digoxin - PO - 0.5 mg - Plasma - agg. (n=11)", - "Reitman 2011 - Week 2 after Perpetrator (Rifampicin) - Digoxin - PO - 0.5 mg - Plasma - agg. (n=11)", "Reitman 2011 - Week 4 after Perpetrator (Rifampicin) - Digoxin - PO - 0.5 mg - Plasma - agg. (n=11)", - "Verstuyft 2003 - 0.5mg with dipyridamole - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", - "Verstuyft 2003 - 0.5mg with dipyridamole - Digoxin - PO - 0.5 mg - Urine - agg. (n=12)", + "Verstuyft 2003 - 0.5mg with Placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", + "Verstuyft 2003 - 0.5mg with placebo - Digoxin - PO - 0.5 mg - Urine - agg. (n=12)", "Wagner 1981 - 0.5mg po - Digoxin - PO - 0.5 mg - Urine - agg. (n=6)", "Wagner 1981 - 0.5mg po - Digoxin - PO - 0.5 mg - Plasma - agg. (n=6)", "Becquemont 2001 - 0.5mg po - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", - "Becquemont 2001 - 0.5mg po with grapefruit juice - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", "Ragueneau 1999 - 0.5mg po with placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=18)", - "Ragueneau 1999 - 0.5mg po with clarithromycin - Digoxin - PO - 0.5 mg - Plasma - agg. (n=18)", - "Tayrouz 2003 - 0.5mg po with Cremophor RH40 - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", - "Westphal 2000 - 0.5mg po with talinolol p.o. - Digoxin - PO - 0.5 mg - Plasma - agg. (n=10)", - "Westphal 2000 - 0.5mg po with talinolol i.v. - Digoxin - PO - 0.5 mg - Plasma - agg. (n=10)" + "Tayrouz 2003 - 0.5mg po with placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", + "Westphal 2000 - 0.5mg po - Digoxin - PO - 0.5 mg - Plasma - agg. (n=10)", + "Verstuyft 2003 - 0.5mg with dipyridamole - Digoxin - PO - 0.5 mg - Urine - agg. (n=12)" ] }, { "Name": "0.75 mg", "Classifiables": [ - "Rengelshausen 2003 - 0.75mg/kg po with placebo - Digoxin - PO - 0.75 mg - Plasma - agg. (n=12)", - "Rengelshausen 2003 - 0.75mg/kg po with clarithromycin - Digoxin - PO - 0.75 mg - Plasma - agg. (n=12)" + "Rengelshausen 2003 - 0.75mg/kg po with placebo - Digoxin - PO - 0.75 mg - Plasma - agg. (n=12)" ] }, { "Name": "0.6 mg", "Classifiables": [ - "Martin 1997 - 0.6mg po - Digoxin - PO - 0.6 mg - Plasma - agg. (n=12)", - "Martin 1997 - 0.6mg po with Eprosartan - Digoxin - PO - 0.6 mg - Plasma - agg. (n=12)" + "Martin 1997 - 0.6mg po - Digoxin - PO - 0.6 mg - Plasma - agg. (n=12)" ] }, { "Name": "0.125 mg", "Classifiables": [ - "Qiu 2010 - 0.125mg md QD placebo - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", - "Qiu 2010 - 0.125mg md QD with dimebon 20mg TID - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)" + "Qiu 2010 - 0.125mg md QD placebo - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)" ] } ] @@ -28364,41 +35817,39 @@ { "Name": "0.5 mg", "Classifiables": [ - "Ochs 1978 - 0.5mg - Digoxin - IV - 0.5 mg - Urine - agg. (n=9)", - "Ochs 1975 - 0.5mg Patients with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Urine - agg. (n=8)", "Ochs 1975 - 0.5mg Patient 1 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ding 2004 - 0.5mg iv placebo - Digoxin - IV - 0.5 mg - Plasma - agg. (n=12)", - "Ochs 1975 - 0.5mg Patient 2 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 3 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 4 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 5 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 6 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 7 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 8 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1978 - 0.5mg - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", "Wagner 1981 - 0.5mg iv 1h - Digoxin - IV - 0.5 mg - Urine - agg. (n=6)", "Wagner 1981 - 0.5mg iv 3h - Digoxin - IV - 0.5 mg - Urine - agg. (n=6)", "Wagner 1981 - 0.5mg iv bolus - Digoxin - IV - 0.5 mg - Urine - agg. (n=6)", "Wagner 1981 - 0.5mg iv 1h - Digoxin - IV - 0.5 mg - Plasma - agg. (n=6)", "Wagner 1981 - 0.5mg iv 3h - Digoxin - IV - 0.5 mg - Plasma - agg. (n=6)", "Wagner 1981 - 0.5mg iv bolus - Digoxin - IV - 0.5 mg - Plasma - agg. (n=6)", - "Ding 2004 - 0.5mg iv with ritonavir - Digoxin - IV - 0.5 mg - Plasma - agg. (n=12)", + "Ding 2004 - 0.5mg iv placebo - Digoxin - IV - 0.5 mg - Plasma - agg. (n=12)", + "Tsutsumi 2002 - 0.5mg iv - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", + "Tsutsumi 2002 - 0.5mg iv with erythromycin - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", + "Tsutsumi 2002 - 0.5mg iv with clarithromycin - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", "Tsutsumi 2002 - 0.5mg iv - Digoxin - IV - 0.5 mg - Urine - agg. (n=9)", "Tsutsumi 2002 - 0.5mg iv with erythromycin - Digoxin - IV - 0.5 mg - Urine - agg. (n=9)", "Tsutsumi 2002 - 0.5mg iv with clarithromycin - Digoxin - IV - 0.5 mg - Urine - agg. (n=9)", - "Ochs 1978 - 0.5mg - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", - "Tsutsumi 2002 - 0.5mg iv - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", - "Tsutsumi 2002 - 0.5mg iv with erythromycin - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)", - "Tsutsumi 2002 - 0.5mg iv with clarithromycin - Digoxin - IV - 0.5 mg - Plasma - agg. (n=9)" + "Ochs 1975 - 0.5mg Patients with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Urine - agg. (n=8)", + "Ochs 1978 - 0.5mg - Digoxin - IV - 0.5 mg - Urine - agg. (n=9)", + "Ochs 1975 - 0.5mg Patient 2 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1975 - 0.5mg Patient 3 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1975 - 0.5mg Patient 4 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1975 - 0.5mg Patient 5 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1975 - 0.5mg Patient 6 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1975 - 0.5mg Patient 7 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Ochs 1975 - 0.5mg Patient 8 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv." ] }, { "Name": "1 mg", "Classifiables": [ - "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Urine - agg. (n=9)", "Greiner 1999 - iv Control (Perpetrator Placebo) - Digoxin - IV - 1 mg - Plasma - agg. (n=8)", - "Greiner 1999 - iv with Perpetrator (Rifampicin) - Digoxin - IV - 1 mg - Plasma - agg. (n=8)", "Kramer 1979 - 1mg iv bolus - Digoxin - IV - 1 mg - Plasma - agg. (n=12)", - "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Plasma - agg. (n=9)" + "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Plasma - agg. (n=9)", + "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Urine - agg. (n=9)" ] }, { @@ -28418,9 +35869,8 @@ { "Name": "1.5 mg", "Classifiables": [ - "Ochs 1978 - 1.5mg - Digoxin - IV - 1.5 mg - Urine - agg. (n=9)", "Ochs 1978 - 1.5mg - Digoxin - IV - 1.5 mg - Plasma - agg. (n=9)", - "Ochs 1978 - 1.5mg - Digoxin - IV - 1.5 mg - Plasma - agg. (n=9) 1" + "Ochs 1978 - 1.5mg - Digoxin - IV - 1.5 mg - Urine - agg. (n=9)" ] } ] @@ -28458,7 +35908,8 @@ "Digoxin po, 0.5 mg", "Digoxin po, 0.6 mg", "Digoxin po, 0.75 mg", - "Digoxin po, 1.0 mg" + "Digoxin po, 1.0 mg", + "Digoxin po, 0.4 mg" ] }, { From caded1d8f417c955a6bc4e646ac5626b748efffe Mon Sep 17 00:00:00 2001 From: Thomas Wendl Date: Fri, 20 Sep 2024 17:32:36 +0200 Subject: [PATCH 2/2] 0.4 mg PO simulation added and evaluation plan adjusted --- Digoxin-Model.json | 315 +++++++++++--------------- Evaluation/Input/evaluation_plan.json | 63 +++++- 2 files changed, 195 insertions(+), 183 deletions(-) diff --git a/Digoxin-Model.json b/Digoxin-Model.json index 81f8ba3..ed10dba 100644 --- a/Digoxin-Model.json +++ b/Digoxin-Model.json @@ -9970,181 +9970,6 @@ "Unit": "h" } }, - { - "Name": "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", - "ExtendedProperties": [ - { - "Name": "DB Version", - "Value": "OSP DATABASE", - "Type": "String" - }, - { - "Name": "ID", - "Value": 226.0, - "Type": "Double" - }, - { - "Name": "Study Id", - "Value": "Gurley 2008b", - "Type": "String" - }, - { - "Name": "Reference", - "Value": "https://www.ncbi.nlm.nih.gov/pubmed/18214850", - "Type": "String" - }, - { - "Name": "Source", - "Value": "Fig. 1", - "Type": "String" - }, - { - "Name": "Grouping", - "Value": "Control (Perpetrator Placebo)", - "Type": "String" - }, - { - "Name": "Data type", - "Value": "aggregated", - "Type": "String" - }, - { - "Name": "N", - "Value": 18.0, - "Type": "Double" - }, - { - "Name": "Molecule", - "Value": "Digoxin", - "Type": "String" - }, - { - "Name": "Species", - "Value": "Human", - "Type": "String" - }, - { - "Name": "Organ", - "Value": "Peripheral Venous Blood", - "Type": "String" - }, - { - "Name": "Compartment", - "Value": "Plasma", - "Type": "String" - }, - { - "Name": "Route", - "Value": "PO", - "Type": "String" - }, - { - "Name": "Dose", - "Value": "0.25 mg", - "Type": "String" - }, - { - "Name": "Times of Administration [h]", - "Value": 0.0, - "Type": "Double" - }, - { - "Name": "Formulation", - "Value": "0.25 mg, Lanoxin®, GlaxoSmithKline", - "Type": "String" - }, - { - "Name": "Food state", - "Value": "Fasted", - "Type": "String" - }, - { - "Name": "Comment", - "Value": ".", - "Type": "String" - } - ], - "Columns": [ - { - "Name": "Avg", - "RelatedColumns": [ - { - "Name": "Var", - "QuantityInfo": { - "Path": "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)|ObservedData|Peripheral Venous Blood|Plasma|Digoxin|ArithmeticStdDev" - }, - "DataInfo": { - "Origin": "ObservationAuxiliary", - "AuxiliaryType": "ArithmeticStdDev", - "MolWeight": 780.93 - }, - "Values": [ - "NaN", - 0.0001054546, - 0.00037818178, - 0.000316363818, - 0.0003054546, - 0.0003054546, - 0.0002654545, - 0.0002763636, - 0.0001781818, - 0.0001127273 - ], - "Dimension": "Concentration (mass)", - "Unit": "mg/l" - } - ], - "QuantityInfo": { - "Path": "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)|ObservedData|Peripheral Venous Blood|Plasma|Digoxin|ArithmeticMean" - }, - "DataInfo": { - "Origin": "Observation", - "AuxiliaryType": "Undefined", - "MolWeight": 780.93, - "LLOQ": 1E-10 - }, - "Values": [ - 0.05, - 0.1854545, - 0.76, - 1.101818, - 1.090909, - 0.8836364, - 0.7927273, - 0.7236364, - 0.5127273, - 0.32 - ], - "Dimension": "Concentration (mass)", - "Unit": "µg/l" - } - ], - "BaseGrid": { - "Name": "Time", - "QuantityInfo": { - "Path": "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)|Time", - "Type": "Time" - }, - "DataInfo": { - "Origin": "BaseGrid", - "AuxiliaryType": "Undefined" - }, - "Values": [ - 0.0, - 0.33, - 0.67, - 1.0, - 1.5, - 2.0, - 2.5, - 3.0, - 4.0, - 6.0 - ], - "Dimension": "Time", - "Unit": "h" - } - }, { "Name": "Jalava 1997 - po Control (Perpetrator Placebo) - Digoxin - PO - 0.5 mg - Serum - agg. (n=10)", "ExtendedProperties": [ @@ -35761,14 +35586,41 @@ { "Name": "0.25 mg", "Classifiables": [ - "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", "Eckermann 2012 - 0.25mg po - Digoxin - PO - 250 µg - Plasma - agg. (n=16)", "Friedrich 2011 - 0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=20)", "Johne 1999 - 0.25mg po md with placebo day 6 - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", "Johne 1999 - 0.25mg po md with placebo day 15 - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", "Kirch 1986 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=7)", "Rodin 1988 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=10)", - "Vaidyanathan 2008 - 0.25mg po pd - Digoxin - PO - 0.25 mg - Plasma - agg. (n=22)" + "Rodin 1988 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Plasma - agg. (n=9)", + "Vaidyanathan 2008 - 0.25mg po pd - Digoxin - PO - 0.25 mg - Plasma - agg. (n=22)", + "Wiebe 2020 - Control digoxin - plasma - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", + "Wiebe 2020 - Control digoxin - urine - Digoxin - PO - 0.25 mg - Urine - agg. (n=12)", + "Wiebe 2020 - DDI digoxin + verapamil - plasma - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", + "Wiebe 2020 - DDI digoxin + verapamil - urine - Digoxin - PO - 0.25 mg - Urine - agg. (n=12)", + "Klein et al. 1982 - Digoxin and Verapamil in MD setting - Digoxin - PO - 0.25 mg - Serum - agg. (n=7)", + "Wiebe 2020 - Digoxin (Cocktail) + Rifampin - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", + "Wiebe 2020 - Digoxin (Cocktail) + Rifampin - Digoxin - PO - 0.25 mg - Urine - agg. (n=12)", + "Wiebe 2020 - Digoxin + Placebo - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", + "Wiebe 2020 - Digoxin + Placebo - Digoxin - PO - 0.25 mg - Urine - agg. (n=12)", + "Kurata 2002 - G/G2677C/C3435_Digoxin day 16 + Clarithromycin - Digoxin - PO - 0.25 mg - serum - agg. (n=5)", + "Kurata 2002 - T/T2677T/T3435_Digoxin day 16 + Clarithromycin - Digoxin - PO - 0.25 mg - serum - agg. (n=5)", + "Kurata 2002 - G/T2677C/T3435_Digoxin day 16 + Clarithromycin - Digoxin - PO - 0.25 mg - serum - agg. (n=5)", + "Partanen 1995 - Digoxin + Itraconazol in Part 1 - Digoxin - PO - 0.25 mg - serum - agg. (n=10)", + "Partanen 1995 - Digoxin + Itraconazol in Part 2 - Digoxin - PO - 0.25 mg - serum - agg. (n=10)", + "Gurley 2008b - Digoxin without Hyperforin - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Gurley 2008b - Digoxin with Hyperforin - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Johne 1999 - Digoxin MD with placebo - Digoxin - PO - 0.25 mg - Plasma - agg. (n=12)", + "Johne 1999 - Digoxin after SD St John's Wort - Digoxin - PO - 0.25 mg - Plasma - agg. (n=13)", + "Johne 1999 - Digoxin after MD St John's Wort - Digoxin - PO - 0.25 mg - Plasma - agg. (n=13)", + "Rodin 1988 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Urine - agg. (n=10)", + "Rodin 1988 - 2x0.25mg po md with verapamil - Digoxin - PO - 0.25 mg - Urine - agg. (n=10)", + "Rodin 1988 - 2x0.25mg po md - Digoxin - PO - 0.25 mg - Urine - agg. (n=9)", + "Rodin 1988 - 2x0.25mg po md with isradipine - Digoxin - PO - 0.25 mg - Urine - agg. (n=9)", + "Gurley 2008b - with Perpetrator (Echinacea) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Gurley 2008b - Control to Perpetrator Rifampicin - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Gurley 2008b - Control to Perpetrator Clarithromycin - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Gurley 2008b - Control to Perpetrator Echinacea - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)" ] }, { @@ -35788,7 +35640,14 @@ "Ragueneau 1999 - 0.5mg po with placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=18)", "Tayrouz 2003 - 0.5mg po with placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=12)", "Westphal 2000 - 0.5mg po - Digoxin - PO - 0.5 mg - Plasma - agg. (n=10)", - "Verstuyft 2003 - 0.5mg with dipyridamole - Digoxin - PO - 0.5 mg - Urine - agg. (n=12)" + "Verstuyft 2003 - 0.5mg with dipyridamole - Digoxin - PO - 0.5 mg - Urine - agg. (n=12)", + "Kurata 2002 - G/G2677C/C3435_Digoxin day 1 - Digoxin - PO - 0.5 mg - Serum - agg. (n=5)", + "Kurata 2002 - T/T2677T/T3435_Digoxin day 1 - Digoxin - PO - 0.5 mg - serum - agg. (n=5)", + "Kurata 2002 - G/T2677C/T3435_Digoxin day 1 - Digoxin - PO - 0.5 mg - serum - agg. (n=5)", + "Gurley 2007 - Digoxin + Rifampicin - Digoxin - PO - 0.5 mg - serum - agg. (n=20)", + "Gurley 2007 - Digoxin + Clarithromycin - Digoxin - PO - 0.5 mg - serum - agg. (n=20)", + "Gurley 2007 - control to Rifampicin - Digoxin - PO - 0.5 mg - serum - agg. (n=20)", + "Gurley 2007 - control to Clarithromycin - Digoxin - PO - 0.5 mg - serum - agg. (n=20)" ] }, { @@ -35806,7 +35665,80 @@ { "Name": "0.125 mg", "Classifiables": [ - "Qiu 2010 - 0.125mg md QD placebo - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)" + "Qiu 2010 - 0.125mg md QD placebo - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Belz et al. 1983 - Digoxin + 80mg Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Belz et al. 1983 - Digoxin + 120mg Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Doering et al. 1983 - Digoxin control - Digoxin - PO - 0.125 mg - Serum - agg. (n=9)", + "Doering et al. 1983 - Digoxin+ 80mg Verapamil - Digoxin - PO - 0.125 mg - Serum - agg. (n=9)", + "Belz 1981 - Digoxin + Placebo - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Belz 1981 - Digoxin + Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Belz et al. 1983 - Digoxin control to 80mg Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Belz et al. 1983 - Digoxin control to 120mg Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)" + ] + }, + { + "Name": "1/0.0625/0.125 mg", + "Classifiables": [ + "Pedersen et al. 1982 - Digoxin and Verapamil in MD setting - Digoxin - PO - 1/0.0625/0.125 mg - Plasma - agg. (n=7)" + ] + }, + { + "Name": "0.46 mg", + "Classifiables": [ + "Schwartz et al. 1982 - Digoxin and Verapamil in MD setting - Digoxin - PO - 0.46 mg - Serum - agg. (n=10)" + ] + }, + { + "Name": "0.4 mg", + "Classifiables": [ + "Gurley 2006 - day 7 plasma + Rifampin - Digoxin - PO - 0.4 mg - serum - agg. (n=16)", + "Gurley 2006 - day 7 plasma + Clarithromycin - Digoxin - PO - 0.4 mg - serum - agg. (n=16)", + "Gurley 2006 - day 1 plasma before Rifampicin - Digoxin - PO - 0.4 mg - serum - agg. (n=16)", + "Gurley 2006 - day 1 plasma before Clarithromycin - Digoxin - PO - 0.4 mg - serum - agg. (n=16)" + ] + }, + { + "Name": "0.75 (day 1 and 2); 0.25 days 3 (sampling day) mg", + "Classifiables": [ + "Arold 2005 - Study B - Digoxin without Hyperforin (Day 1) - Digoxin - PO - 0.75 (day 1 and 2); 0.25 days 3 (sampling day) mg - Plasma - agg. (n=28)" + ] + }, + { + "Name": "0.75 (day 1 and 2); 0.25 days 3 to 13 mg", + "Classifiables": [ + "Arold 2005 - Study B - Digoxin with Hyperforin - Digoxin - PO - 0.75 (day 1 and 2); 0.25 days 3 to 13 mg - Plasma - agg. (n=16)", + "Arold 2005 - Study B - Digoxin with Placebo - Digoxin - PO - 0.75 (day 1 and 2); 0.25 days 3 to 13 mg - Plasma - agg. (n=12)" + ] + }, + { + "Name": "unknown, see comment ", + "Classifiables": [ + "Mueller 2004 - study part 1 - Placebo - before - Digoxin - PO - unknown, see comment - Plasma - agg. (n=5)", + "Mueller 2004 - study part 1 - Placebo - after - Digoxin - PO - unknown, see comment - Plasma - agg. (n=5)", + "Mueller 2004 - study part 1 - LI160 (~28.9mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=6)", + "Mueller 2004 - study part 1 - LI160 (~28.9mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=6)", + "Mueller 2004 - study part 1 - Hypericum powder type A, 4 g/d (~21.1mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=5)", + "Mueller 2004 - study part 1 - Hypericum powder type A, 4 g/d (~21.1mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=5)", + "Mueller 2004 - study part 1 - Hypericum powder type A, 2 g/d (~10.6mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=6)", + "Mueller 2004 - study part 1 - Hypericum powder type A, 2 g/d (~10.6mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=6)", + "Mueller 2004 - study part 2 - Placebo - before - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - study part 2 - Placebo - after - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Hypericum powder type A, 1 g/d (~5.3mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Hypericum powder type A, 1 g/d (~5.3mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Hypericum powder type A, 0.5 g/d (~2.6mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Hypericum powder type A, 0.5 g/d (~2.6mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Hypericum oil extract (~0.13mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Hypericum oil extract (~0.13mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Tea (~0.04mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - Tea (~0.04mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - study part 3 - Placebo - before - Digoxin - PO - unknown, see comment - Plasma - agg. (n=9)", + "Mueller 2004 - study part 3 - Placebo - after - Digoxin - PO - unknown, see comment - Plasma - agg. (n=9)", + "Mueller 2004 - Hypericum powder type B, 2 g/d (~0.3mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=10)", + "Mueller 2004 - Hypericum powder type B, 2 g/d (~0.3mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=10)", + "Mueller 2004 - Fresh plant juice (~3.56mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=10)", + "Mueller 2004 - Fresh plant juice (~3.56mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=10)", + "Mueller 2004 - ZE 117 (~ca-0.38mg/d hyperforin) - without hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)", + "Mueller 2004 - ZE 117 (~ca-0.38mg/d hyperforin) - with hyperforin - Digoxin - PO - unknown, see comment - Plasma - agg. (n=7)" ] } ] @@ -35840,7 +35772,10 @@ "Ochs 1975 - 0.5mg Patient 5 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", "Ochs 1975 - 0.5mg Patient 6 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", "Ochs 1975 - 0.5mg Patient 7 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", - "Ochs 1975 - 0.5mg Patient 8 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv." + "Ochs 1975 - 0.5mg Patient 8 with normal colon mucosa - Digoxin - Intracolonic - 0.5 mg - Plasma - indiv.", + "Kurata 2002 - G/G2677C/C3435_Digoxin day 1 - Digoxin - IV - 0.5 mg - serum - agg. (n=5)", + "Kurata 2002 - T/T2677T/T3435_Digoxin day 1 - Digoxin - IV - 0.5 mg - serum - agg. (n=5)", + "Kurata 2002 - G/T2677C/T3435_Digoxin day 1 - Digoxin - IV - 0.5 mg - serum - agg. (n=5)" ] }, { @@ -35849,13 +35784,21 @@ "Greiner 1999 - iv Control (Perpetrator Placebo) - Digoxin - IV - 1 mg - Plasma - agg. (n=8)", "Kramer 1979 - 1mg iv bolus - Digoxin - IV - 1 mg - Plasma - agg. (n=12)", "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Plasma - agg. (n=9)", - "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Urine - agg. (n=9)" + "Ochs 1978 - 1mg - Digoxin - IV - 1 mg - Urine - agg. (n=9)", + "Johnson et al. 1987 - Digoxin IV control - Digoxin - IV - 1 mg - Serum - agg. (n=12)", + "Johnson et al. 1987 - Digoxin IV control - Digoxin - IV - 1 mg - Urine - agg. (n=12)", + "Johnson et al. 1987 - Digoxin IV + Verapamil - Digoxin - IV - 1 mg - Serum - agg. (n=12)", + "Johnson et al. 1987 - Digoxin IV + Verapamil - Digoxin - IV - 1 mg - Urine - agg. (n=12)", + "Pedersen et al. 1983 - Digoxin IV control - Digoxin - IV - 1 mg - Plasma - indiv.", + "Pedersen et al. 1983 - Digoxin IV + Verapamil - Digoxin - IV - 1 mg - Plasma - indiv.", + "Pedersen 1981 - Digoxin without Verapamil - Digoxin - IV - 1 mg - Urine - agg. (n=7)" ] }, { "Name": "0.75 mg", "Classifiables": [ - "Koup 1975 - 0.75mg iv h - Digoxin - IV - 0.75 mg - Plasma - indiv." + "Koup 1975 - 0.75mg iv h - Digoxin - IV - 0.75 mg - Plasma - indiv.", + "Pedersen 1981 - Digoxin withVerapamil - Digoxin - IV - 0.75 mg - Urine - agg. (n=7)" ] }, { @@ -35872,6 +35815,14 @@ "Ochs 1978 - 1.5mg - Digoxin - IV - 1.5 mg - Plasma - agg. (n=9)", "Ochs 1978 - 1.5mg - Digoxin - IV - 1.5 mg - Urine - agg. (n=9)" ] + }, + { + "Name": "0.25 mg", + "Classifiables": [ + "Kurata 2002 - G/G2677C/C3435_Digoxin day 16 + Clarithromycin - Digoxin - IV - 0.25 mg - serum - agg. (n=5)", + "Kurata 2002 - T/T2677T/T3435_Digoxin day 16 + Clarithromycin - Digoxin - IV - 0.25 mg - serum - agg. (n=5)", + "Kurata 2002 - G/T2677C/T3435_Digoxin day 16 + Clarithromycin - Digoxin - IV - 0.25 mg - serum - agg. (n=5)" + ] } ] } diff --git a/Evaluation/Input/evaluation_plan.json b/Evaluation/Input/evaluation_plan.json index 12d0bcf..b498e88 100644 --- a/Evaluation/Input/evaluation_plan.json +++ b/Evaluation/Input/evaluation_plan.json @@ -179,6 +179,11 @@ "Simulation": "Digoxin po, 0.25 mg", "SectionReference": "ct-profiles-model-building" }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.4 mg", + "SectionReference": "ct-profiles-model-building" + }, { "Project": "Digoxin", "Simulation": "Digoxin po, 0.5 mg", @@ -410,9 +415,37 @@ "Project": "Digoxin", "Simulation": "Digoxin po, 0.25 mg", "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", - "ObservedData": "Gurley 2008b - Control (Perpetrator Placebo) - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "ObservedData": "Gurley 2008b - Control to Perpetrator Clarithromycin - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Color": "#005295" + }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.25 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Gurley 2008b - Control to Perpetrator Echinacea - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", "Color": "#005295" }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.25 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Gurley 2008b - Control to Perpetrator Rifampicin - Digoxin - PO - 0.25 mg - Serum - agg. (n=18)", + "Color": "#005295" + }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.4 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Gurley 2006 - day 1 plasma before Clarithromycin - Digoxin - PO - 0.4 mg - serum - agg. (n=16)", + "Color": "#005295" + }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.4 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Gurley 2006 - day 1 plasma before Rifampicin - Digoxin - PO - 0.4 mg - serum - agg. (n=16)", + "Color": "#005295" + }, { "Project": "Digoxin", "Simulation": "Digoxin po, 0.5 mg", @@ -469,6 +502,20 @@ "ObservedData": "Ragueneau 1999 - 0.5mg po with placebo - Digoxin - PO - 0.5 mg - Plasma - agg. (n=18)", "Color": "#005295" }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.5 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Gurley 2007 - control to Rifampicin - Digoxin - PO - 0.5 mg - serum - agg. (n=20)", + "Color": "#005295" + }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po, 0.5 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Gurley 2007 - control to Clarithromycin - Digoxin - PO - 0.5 mg - serum - agg. (n=20)", + "Color": "#005295" + }, { "Project": "Digoxin", "Simulation": "Digoxin po, 0.6 mg", @@ -517,6 +564,20 @@ "ObservedData": "Qiu 2010 - 0.125mg md QD placebo - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", "Color": "#008000" }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po MD, 0.125 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Belz et al. 1983 - Digoxin control to 80mg Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Color": "#008000" + }, + { + "Project": "Digoxin", + "Simulation": "Digoxin po MD, 0.125 mg", + "Output": "Organism|PeripheralVenousBlood|Digoxin|Plasma (Peripheral Venous Blood)", + "ObservedData": "Belz et al. 1983 - Digoxin control to 120mg Verapamil - Digoxin - PO - 0.125 mg - Plasma - agg. (n=12)", + "Color": "#008000" + }, { "Project": "Digoxin", "Simulation": "Digoxin po MD, 0.25 mg",