Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions:
Gespeichert in:
1. Verfasser: | |
---|---|
Format: | Abschlussarbeit Buch |
Sprache: | English |
Veröffentlicht: |
Aachen
Apprimus Verlag
2023
|
Ausgabe: | 1. Auflage |
Schriftenreihe: | Applied microbiology
Volume 29 |
Schlagworte: | |
Online-Zugang: | kostenfrei Inhaltsverzeichnis Inhaltsverzeichnis |
Beschreibung: | 160 Seiten Illustrationen, Diagramme 21 cm, 250 g |
ISBN: | 9783985551354 3985551359 |
DOI: | 10.18154/RWTH-2023-00622 |
Internformat
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100 | 1 | |a Baier, Vanessa |d 1989- |e Verfasser |0 (DE-588)1279555629 |4 aut | |
245 | 1 | 0 | |a Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |c Vanessa Baier |
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264 | 1 | |a Aachen |b Apprimus Verlag |c 2023 | |
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776 | 0 | 8 | |i Erscheint auch als |a Baier, Vanessa, 1989- |t Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |d Aachen : Universitätsbibliothek der RWTH Aachen, 2023 |h Online-Ressource |n Online-Ausgabe |
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Datensatz im Suchindex
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adam_text | CONTENTS
EIDESSTATTLICHE
ERKLARUNG
......................................................................................................................
I
FUNDING
...................................................................................................................................................
III
ACKNOWLEDGEMENTS
................................................................................................................................
ABSTRACT
.................................................................................................................................................VII
ZUSAMMENFASSUNG
...............................................................................................................................
LIST
OF
FIGURES
......................................................................................................................................
XIII
LIST
OF
TABLES
.........................................................................................................................................
XV
LIST
OF
ABBREVIATIONS
.........................................................................................................................XVII
GENERAL
INTRODUCTION
.........................................................................................................................
19
PART
I:
BACKGROUND
...............................................................................................................................
25
1
D
RUG
-
INDUCED
ADVERSE
REACTIONS
......................................................................................................................
27
2
D
RUG
-
INDUCED
LIVER
INJURY
..................................................................................................................................
31
3
P
HARMACOKINETICS
................................................................................................................................................
33
4
P
HARMACOGENOMICS
..............................................................................................................................................
36
5
P
HARMACODYNAMICS
..............................................................................................................................................
37
6
C
OMPUTATIONAL
MODELLING
IN
PHARMACOMETRICS
...........................................................................................
39
6.1
PBPK
MODELLING
...............................................................................................................................................
40
6.2
POPULATION
PBPK
MODELLING
............................................................................................................................
43
6.3
PD
AND
QSP
MODELLING
....................................................................................................................................
43
PART
II:
MATERIALS
&
METHODS
.......
...................................................................................................
45
7
SOFTWARE
...............................................................................................................................................................
47
8
M
ATERIALSAND
M
ETHODS
USED
IN
C
HAPTER
11
..................................................................................................
47
8.1
MODEL
BUILDING
................................................................................................................................................
47
8.2
COMPETITIVE
INHIBITION
OF
BSEP
TRANSPORT
BY
CYCLOSPORINE
A
....................................................................
48
8.3
OBSERVED
DATA
................................................................................................................................................
49
8.4
DATA
NORMALISATION
.........................................................................................................................................
49
8.5
GOODNESS
OF
FIT
...............................................................................................................................................
49
9
M
ATERIALS
AND
M
ETHODS
USED
IN
C
HAPTER
12
..................................................................................................
50
9.1
DRUG-SPECIFIC
PBPK
MODELS
............................................................................................................................
50
9.2
MODEL-BASED
IN
VITRO
ASSAY
............................................................................................................................
50
9.3
INTEGRATION
OF
EXPRESSION
DATA
INTO
THE
PBBA
MODEL
..................................................................................50
9.4
POPULATION
SIMULATIONS
..................................................................................................................................
51
9.5
CHOLESTATIC
POTENTIAL
.......................................................................................................................................51
10
M
ATERIALSAND
M
ETHODS
USED
IN
C
HAPTER
13
................................................................................................
51
10.1
PBPK
MODEL
BUILDING
....................................................................................................................................
51
10.2
LITERATURE
PKDATA
.........................................................................................................................................
51
10.3
VIRTUAL
POPULATIONS
........................................................................................................................................
53
CONTENTS
PART
III
:
RESULTS
......................................................................................................................................
55
11
A
P
HYSIOLOGY
-B
ASED
M
ODEL
OF
H
UMAN
B
ILE
A
CID
M
ETABOLISM
FOR
P
REDICTING
B
ILE
A
CID
T
ISSUE
L
EVELS
AFTER
D
RUG
A
DMINISTRATION
IN
H
EALTHY
S
UBJECTSAND
BRIC
T
YPE
2
P
ATIENTS
...................................
57
11.1
INTRODUCTION
....................................................................................................................................................
58
11.2
RESULTS
.............................................................................................................................................................60
11.3
DISCUSSION
AND
CONCLUSION
............................................................................................................................
65
12
A
M
ODEL
-B
ASED
W
ORKFLOW
TO
B
ENCHMARK
THE
C
LINICAL
C
HOLESTASIS
R
ISK
OF
D
RUGS
.............................
69
12.1
INTRODUCTION
....................................................................................................................................................70
12.2
RESULTS
.............................................................................................................................................................
70
12.3
DISCUSSION
.......................................................................................................................................................
77
13
PBPK
GUIDED
ASSESSMENT
OF
A
LIVER
FUNCTION
TEST
.......................................................................................
79
13.1
INTRODUCTION
....................................................................................................................................................
80
13.2
RESULTS
.............................................................................................................................................................81
13.3
DISCUSSION
.......................................................................................................................................................
95
GENERAL
CONCLUSION
AND
OUTLOOK
.....................................................................................................
99
REFERENCES
...........................................................................................................................................
103
PART
IV:
APPENDICES
...........................................................................................................................
121
APPENDIX
A
...........................................................................................................................................
123
A.1
M
ETHODS
.........................................................................................................................................................
123
A.1.1
BUILD
A
BASIC
PBPK
MODEL
FOR
GCDCA
IN
PK-SIM
...................................................................................
124
A.1.2
EXTEND
THE
PBPK
MODEL
FOR
GCDCA
IN
MOBI
.........................................................................................
125
A.2
F
IGURES
.............................................................................................................................................................
126
A.3
T
ABLES
..............................................................................................................................................................
126
APPENDIX
B
...........................................................................................................................................
127
B.1
M
ETHODS
.........................................................................................................................................................
127
B.1.1
PBPK-ASSISTED
LIVER
SPHEROID
IN
VITRO
ASSAY
...........................................................................................
127
B.1.2
CLINICAL
DATA
..............................................................................................................................................
127
B.1.3
TRANSCRIPTOME
ANALYSIS
...........................................................................................................................
128
B.2
F
IGURES
............................................................................................................................................................
129
B.3
T
ABLES
.............................................................................................................................................................
140
APPENDIX
C
...........................................................................................................................................
145
C.1
F
IGURES
............................................................................................................................................................
145
C.2
T
ABLES
.............................................................................................................................................................
149
APPENDIX
D
.........................................................................................................................................
157
D.1
C
URRICULUM
V
ITAE
..........................................................................................................................................
157
D.2
P
UBLICATIONS
....................................................................................................................................................
159
|
adam_txt |
CONTENTS
EIDESSTATTLICHE
ERKLARUNG
.
I
FUNDING
.
III
ACKNOWLEDGEMENTS
.
ABSTRACT
.VII
ZUSAMMENFASSUNG
.
LIST
OF
FIGURES
.
XIII
LIST
OF
TABLES
.
XV
LIST
OF
ABBREVIATIONS
.XVII
GENERAL
INTRODUCTION
.
19
PART
I:
BACKGROUND
.
25
1
D
RUG
-
INDUCED
ADVERSE
REACTIONS
.
27
2
D
RUG
-
INDUCED
LIVER
INJURY
.
31
3
P
HARMACOKINETICS
.
33
4
P
HARMACOGENOMICS
.
36
5
P
HARMACODYNAMICS
.
37
6
C
OMPUTATIONAL
MODELLING
IN
PHARMACOMETRICS
.
39
6.1
PBPK
MODELLING
.
40
6.2
POPULATION
PBPK
MODELLING
.
43
6.3
PD
AND
QSP
MODELLING
.
43
PART
II:
MATERIALS
&
METHODS
.
.
45
7
SOFTWARE
.
47
8
M
ATERIALSAND
M
ETHODS
USED
IN
C
HAPTER
11
.
47
8.1
MODEL
BUILDING
.
47
8.2
COMPETITIVE
INHIBITION
OF
BSEP
TRANSPORT
BY
CYCLOSPORINE
A
.
48
8.3
OBSERVED
DATA
.
49
8.4
DATA
NORMALISATION
.
49
8.5
GOODNESS
OF
FIT
.
49
9
M
ATERIALS
AND
M
ETHODS
USED
IN
C
HAPTER
12
.
50
9.1
DRUG-SPECIFIC
PBPK
MODELS
.
50
9.2
MODEL-BASED
IN
VITRO
ASSAY
.
50
9.3
INTEGRATION
OF
EXPRESSION
DATA
INTO
THE
PBBA
MODEL
.50
9.4
POPULATION
SIMULATIONS
.
51
9.5
CHOLESTATIC
POTENTIAL
.51
10
M
ATERIALSAND
M
ETHODS
USED
IN
C
HAPTER
13
.
51
10.1
PBPK
MODEL
BUILDING
.
51
10.2
LITERATURE
PKDATA
.
51
10.3
VIRTUAL
POPULATIONS
.
53
CONTENTS
PART
III
:
RESULTS
.
55
11
A
P
HYSIOLOGY
-B
ASED
M
ODEL
OF
H
UMAN
B
ILE
A
CID
M
ETABOLISM
FOR
P
REDICTING
B
ILE
A
CID
T
ISSUE
L
EVELS
AFTER
D
RUG
A
DMINISTRATION
IN
H
EALTHY
S
UBJECTSAND
BRIC
T
YPE
2
P
ATIENTS
.
57
11.1
INTRODUCTION
.
58
11.2
RESULTS
.60
11.3
DISCUSSION
AND
CONCLUSION
.
65
12
A
M
ODEL
-B
ASED
W
ORKFLOW
TO
B
ENCHMARK
THE
C
LINICAL
C
HOLESTASIS
R
ISK
OF
D
RUGS
.
69
12.1
INTRODUCTION
.70
12.2
RESULTS
.
70
12.3
DISCUSSION
.
77
13
PBPK
GUIDED
ASSESSMENT
OF
A
LIVER
FUNCTION
TEST
.
79
13.1
INTRODUCTION
.
80
13.2
RESULTS
.81
13.3
DISCUSSION
.
95
GENERAL
CONCLUSION
AND
OUTLOOK
.
99
REFERENCES
.
103
PART
IV:
APPENDICES
.
121
APPENDIX
A
.
123
A.1
M
ETHODS
.
123
A.1.1
BUILD
A
BASIC
PBPK
MODEL
FOR
GCDCA
IN
PK-SIM
.
124
A.1.2
EXTEND
THE
PBPK
MODEL
FOR
GCDCA
IN
MOBI
.
125
A.2
F
IGURES
.
126
A.3
T
ABLES
.
126
APPENDIX
B
.
127
B.1
M
ETHODS
.
127
B.1.1
PBPK-ASSISTED
LIVER
SPHEROID
IN
VITRO
ASSAY
.
127
B.1.2
CLINICAL
DATA
.
127
B.1.3
TRANSCRIPTOME
ANALYSIS
.
128
B.2
F
IGURES
.
129
B.3
T
ABLES
.
140
APPENDIX
C
.
145
C.1
F
IGURES
.
145
C.2
T
ABLES
.
149
APPENDIX
D
.
157
D.1
C
URRICULUM
V
ITAE
.
157
D.2
P
UBLICATIONS
.
159 |
any_adam_object | 1 |
any_adam_object_boolean | 1 |
author | Baier, Vanessa 1989- |
author_GND | (DE-588)1279555629 |
author_facet | Baier, Vanessa 1989- |
author_role | aut |
author_sort | Baier, Vanessa 1989- |
author_variant | v b vb |
building | Verbundindex |
bvnumber | BV049035447 |
collection | ebook |
ctrlnum | (OCoLC)1366294730 (DE-599)DNB1278363092 |
doi_str_mv | 10.18154/RWTH-2023-00622 |
edition | 1. Auflage |
format | Thesis Book |
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genre | (DE-588)4113937-9 Hochschulschrift gnd-content |
genre_facet | Hochschulschrift |
id | DE-604.BV049035447 |
illustrated | Illustrated |
index_date | 2024-07-03T22:17:35Z |
indexdate | 2024-07-10T09:53:25Z |
institution | BVB |
institution_GND | (DE-588)1068101474 |
isbn | 9783985551354 3985551359 |
language | English |
oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-034298081 |
oclc_num | 1366294730 |
open_access_boolean | 1 |
owner | DE-29T |
owner_facet | DE-29T |
physical | 160 Seiten Illustrationen, Diagramme 21 cm, 250 g |
psigel | ebook |
publishDate | 2023 |
publishDateSearch | 2023 |
publishDateSort | 2023 |
publisher | Apprimus Verlag |
record_format | marc |
series | Applied microbiology |
series2 | Applied microbiology |
spelling | Baier, Vanessa 1989- Verfasser (DE-588)1279555629 aut Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions Vanessa Baier 1. Auflage Aachen Apprimus Verlag 2023 160 Seiten Illustrationen, Diagramme 21 cm, 250 g txt rdacontent n rdamedia nc rdacarrier Applied microbiology Volume 29 Dissertation RWTH Aachen University 2022 Nebenwirkung (DE-588)4317914-9 gnd rswk-swf Risikoanalyse (DE-588)4137042-9 gnd rswk-swf Pharmakokinetik (DE-588)4115557-9 gnd rswk-swf Arzneimittel (DE-588)4003115-9 gnd rswk-swf Modellierung (DE-588)4170297-9 gnd rswk-swf Hepatose (DE-588)4159555-5 gnd rswk-swf Mikrobiologie adverse drug reactions microbiology pharmacokinetic model (DE-588)4113937-9 Hochschulschrift gnd-content Pharmakokinetik (DE-588)4115557-9 s Modellierung (DE-588)4170297-9 s Nebenwirkung (DE-588)4317914-9 s Arzneimittel (DE-588)4003115-9 s Hepatose (DE-588)4159555-5 s Risikoanalyse (DE-588)4137042-9 s DE-604 Apprimus Verlag (DE-588)1068101474 pbl Erscheint auch als Online-Ausgabe, PDF https://doi.org/10.18154/RWTH-2023-00622 Erscheint auch als Baier, Vanessa, 1989- Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions Aachen : Universitätsbibliothek der RWTH Aachen, 2023 Online-Ressource Online-Ausgabe Applied microbiology Volume 29 (DE-604)BV042644516 29 https://doi.org/10.18154/RWTH-2023-00622 Resolving-System kostenfrei Volltext B:DE-101 application/pdf https://d-nb.info/1278363092/04 Inhaltsverzeichnis DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034298081&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p dnb 20230503 DE-101 https://d-nb.info/provenance/plan#dnb 2\p dnb 20230503 DE-101 https://d-nb.info/provenance/plan#dnb |
spellingShingle | Baier, Vanessa 1989- Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions Applied microbiology Nebenwirkung (DE-588)4317914-9 gnd Risikoanalyse (DE-588)4137042-9 gnd Pharmakokinetik (DE-588)4115557-9 gnd Arzneimittel (DE-588)4003115-9 gnd Modellierung (DE-588)4170297-9 gnd Hepatose (DE-588)4159555-5 gnd |
subject_GND | (DE-588)4317914-9 (DE-588)4137042-9 (DE-588)4115557-9 (DE-588)4003115-9 (DE-588)4170297-9 (DE-588)4159555-5 (DE-588)4113937-9 |
title | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |
title_auth | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |
title_exact_search | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |
title_exact_search_txtP | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |
title_full | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions Vanessa Baier |
title_fullStr | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions Vanessa Baier |
title_full_unstemmed | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions Vanessa Baier |
title_short | Physiologically-based pharmacokinetic modelling for the prediction of adverse drug reactions |
title_sort | physiologically based pharmacokinetic modelling for the prediction of adverse drug reactions |
topic | Nebenwirkung (DE-588)4317914-9 gnd Risikoanalyse (DE-588)4137042-9 gnd Pharmakokinetik (DE-588)4115557-9 gnd Arzneimittel (DE-588)4003115-9 gnd Modellierung (DE-588)4170297-9 gnd Hepatose (DE-588)4159555-5 gnd |
topic_facet | Nebenwirkung Risikoanalyse Pharmakokinetik Arzneimittel Modellierung Hepatose Hochschulschrift |
url | https://doi.org/10.18154/RWTH-2023-00622 https://d-nb.info/1278363092/04 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=034298081&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
volume_link | (DE-604)BV042644516 |
work_keys_str_mv | AT baiervanessa physiologicallybasedpharmacokineticmodellingforthepredictionofadversedrugreactions AT apprimusverlag physiologicallybasedpharmacokineticmodellingforthepredictionofadversedrugreactions |