Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries:
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Abschlussarbeit Buch |
| Sprache: | English |
| Veröffentlicht: |
Uelvesbüll
<<Der>> Andere Verlag
2012
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XIII, 193 S. graph. Darst. |
| ISBN: | 9783862473113 |
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| 245 | 1 | 0 | |a Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries |c Monika Frank |
| 264 | 1 | |a Uelvesbüll |b <<Der>> Andere Verlag |c 2012 | |
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Datensatz im Suchindex
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| adam_text | IMAGE 1
TABLE OF CONTENTS
TABLE OF CONTENTS V
ABBREVIATIONS X
1 INTRODUCTION 1
1.1 THE AIDS EPIDEMIC 1
1.1.1 DISCOVERY OF HIV AS THE CAUSATIVE AGENT FOR AIDS 1
1.1.2 HIV-1 AND HIV-2 2
1.1.3 STATUS OF THE WORLD-WIDE EPIDEMIC 2
1.1.4 ROLE OF MTCT IN RESOURCE-CONSTRAINED COUNTRIES 3
1.2 TREATMENT AND PREVENTION STRATEGIES 5
1.2.1 VACCINES 5
1.2.2 HAART 5
1.2.3 PREVENTION OF MOTHER-TO-CHILD TRANSMISSION OF HIV (PMTCT) PROGRAM
6 1.2.3.1 CHARACTERISTICS OF THE PMTCT PROGRAM 6
1.2.3.2 PMTCT PROGRAM: PROPHYLAXIS AND TREATMENT 8
1.3 HIV REPLICATION MECHANISM AND MECHANISM OF INHIBITION 9
1.3.1 HIV-1 FUNCTIONALITY 9
1.3.2 HIV REPLICATION MECHANISM 10
1.4 HIV INHIBITION MECHANISMS 12
1.4.1 ENTRY INHIBITORS: CCR5 ANTAGONISTS AND FL 12
1.4.2 INTEGRATION INHIBITORS (INL) 12
1.4.3 PROTEASE INHIBITORS (PI) 13
1.4.4 REVERSE TRANSCRIPTASE INHIBITORS: NRTI AND NNRTI 14
1.4.4.1 NUCLEOSIDE/NUCLEOTIDE REVERSE TRANSCRIPTASE INHIBITORS (NRTI) 14
1.4.4.2 NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS (NNRTI) 15
1.4.4.3 NEVIRAPINE (NVP) 16
1.5 POPULATION PHARMACOKINETICS 18
1.5.1 HISTORY 18
1.5.2 NONLINEAR MIXED-EFFECTS MODELLING 19
1.6 OBJECTIVES 20
2 STUDY POPULATIONS AND METHODS 22
2.1 POPULATION PHARMACOKINETIC ANALYSIS 22
2.1.1 NONLINEAR MIXED-EFFECTS AND POPULATION MODELS 22
2.1.1.1 STRUCTURAL SUBMODEL 23
2.1.1.2 PHARMACOSTATISTICAL SUBMODEL 23
2.1.1.3 COVARIATE MODEL 26
2.1.1.4 POPULATION MODEL 27
2.1.2 ESTIMATION METHODS OF POPULATION PHARMACOKINETIC PARAMETERS 28
2.1.3 MODEL SELECTION METHODS 29
V
HTTP://D-NB.INFO/1027506380
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TABLE OF CONTENTS
2.1.3.1 NUMERICAL AND STATISTICAL METHODS 30
2.1.3.2 GRAPHICAL METHODS 30
2.1.4 MODEL EVALUATION: VPC 31
2.2 DATA HANDLING 32
2.2.1 DEVELOPMENT OF DATASETS 32
2.2.2 MISSING OBSERVATIONS AND COVARIATES 32
2.2.3 DATA CHECKOUT 32
2.3 DESCRIPTIVE STATISTICS 33
2.4 SOFTWARE 34
2.5 CLINICAL INVESTIGATIONS 35
2.5.1 PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - PREGNANT
WOMEN/MOTHERS AND
NEWBORNS 35
2.5.1.1 RATIONALE OF INVESTIGATION 35
2.5.1.2 STUDY DESIGN 35
2.5.1.3 STUDY POPULATION 36
2.5.1.4 STUDY TREATMENT 36
2.5.1.5 SAMPLING AND DRUG ANALYSIS 36
2.5.2 PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - HEALTHY MALE
VOLUNTEERS 37 2.5.2.1 RATIONALE OF INVESTIGATION 37
2.5.2.2 STUDY DESIGN 37
2.5.2.3 STUDY POPULATION 37
2.5.2.4 STUDY TREATMENT 37
2.5.2.5 SAMPLING AND DRUG ANALYSIS 37
2.6 POPULATION PHARMACOKINETIC MODELLING STRATEGY AND MODEL
ASSESSMENT/EVALUATION 38
2.6.1 PROJECT I: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - PREGNANT
WOMEN/ MOTHERS 41
2.6.1.1 PLASMA CONCENTRATIONS 41
2.6.1.2 PLASMA AND BREAST MILK CONCENTRATIONS 41
2.6.2 PROJECT II: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - NEWBORNS
42
2.6.3 PROJECT III: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - HEALTHY
MAL
VOLUNTEERS 42
2.6.4 PROJECT IV: INTEGRATED PHARMACOKINETIC MODELS USING DATA/KNOWLEDGE
FROM THEDIFFERENT POPULATIONS 43
2.6.4.1 PREGNANT WOMAN/MOTHER AND NEWBORN CONCENTRATIONS 44
2.6.4.2 PREGNANT WOMAN/MOTHER AND NEWBORN CONCENTRATIONS WITH HEALTHY
MALE
VOLUNTEERS PK PARAMETER INFORMATION AS FIXED PRIOR 44
2.6.4.3 PREGNANT WOMAN/MOTHER AND NEWBORN CONCENTRATIONS WITH HEALTHY
MALE
VOLUNTEERS PK PARAMETERS AS PRIOR INFORMATION 44
2.6.4.4 PREGNANT WOMEN/MOTHER AND NEWBORN CONCENTRATIONS WITH MERGED
HEALTHY
MALE VOLUNTEERS PLASMA CONCENTRATIONS 46
V I
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TABLE OF CONTENTS
2.6.4.5 COMPARISON OF THE DEVELOPED INTEGRATED PK MODELS 46
3 RESULTS 47
3.1 PROJECT I: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - PREGNANT
WOMEN/MOTHERS 47
3.1.1 POPULATION CHARACTERISTICS 47
3.1.2 DATASET AND OBSERVATIONS 48
3.1.3 CONCENTRATION-TIME PROFILES 49
3.1.4 MODEL DEVELOPMENT FOR PLASMA CONCENTRATIONS ALONE 52
3.1.4.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 52
3.1.4.2 BASE MODEL 52
3.1.4.3 COVARIATE ANALYSIS AND FINAL MODEL 55
3.1.5 MODEL DEVELOPMENT OF PLASMA AND BREAST MILK CONCENTRATIONS 56
3.1.5.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 56
3.1.5.2 KEY BASE MODELS FOR MOTHER PLASMA AND BREAST MILK CONCENTRATIONS
69
3.1.5.3 MODEL EVALUATION OF THE KEY BASE MODELS 70
3.1.5.4 FINAL MODEL 72
3.2 PROJECT II: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - NEWBORNS
73
3.2.1 POPULATION CHARACTERISTICS 73
3.2.2 DATASET AND OBSERVATIONS 73
3.2.3 CONCENTRATION-TIME PROFILES 74
3.2.4 MODEL DEVELOPMENT 76
3.2.4.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 77
3.2.4.2 BASE MODEL 80
3.2.4.3 COVARIATE ANALYSIS 82
3.2.4.4 FINAL MODEL 83
3.2.4.5 MODEL EVALUATION 84
3.2.4.6 SIMULATION OF DIFFERENT TIME INTERVALS BETWEEN MATERNAL NVP
ADMINISTRATION AND BIRTH FOR NEWBORNS 86
3.2.4.7 SIMULATION OF DIFFERENT DOSING REGIMENS 87
3.3 PROJECT III: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - HEALTHY
MALE VOLUNTEERS 94
3.3.1 POPULATION CHARACTERISTICS 94
3.3.2 DATASET AND OBSERVATIONS 94
3.3.3 CONCENTRATION-TIME PROFILES 95
3.3.4 MODEL DEVELOPMENT 95
3.3.4.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 95
3.3.4.2 COMPARISON OF THE KEY BASE MODELS FOR HEALTHY MALE VOLUNTEERS
104
3.3.4.3 FINAL MODEL 106
3.3.4.4 MODEL EVALUTATION 107
3.4 PROJECT IV: INTEGRATED PHARMACOKINETIC MODELS USING DATA/KNOWLEDGE
FROM THE
DIFFERENT POPULATIONS 108
V I I
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TABLE OF CONTENTS
3.4.1 MODEL DEVELOPMENT - PREGNANT WOMEN/MOTHER AND NEWBORN
CONCENTRATIONS. 108
3.4.1.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 108
3.4.1.2 BASE MODEL 113
3.4.1.3 COVARIATE ANALYSIS AND FINAL MODEL 114
3.4.1.4 MODEL EVALUATION 117
3.4.2 MODEL DEVELOPMENT - PREGNANT WOMAN/MOTHER AND NEWBORN
CONCENTRATIONS
WITH HEALTHY MALE VOLUNTEERS PK PARAMETER INFORMATION AS FIXED PRIORS
118 3.4.2.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 118
3.4.2.2 MODEL EVALUATION (FIRST-ORDER ABSORPTION PROCESS) 123
3.4.2.3 MODEL EVALUATION (TRANSIT ABSORPTION MODEL) 124
3.4.2.4 FINAL PK MODEL 125
3.4.3 MODEL DEVELOPMENT - PREGNANT WOMAN/MOTHER AND NEWBORN
CONCENTRATIONS
WITH HEALTHY MALE VOLUNTEERS PK PARAMETERS AS PRIOR INFORMATION 126
3.4.3.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 126
3.4.3.2 FINAL MODEL 128
3.4.3.3 MODEL EVALUATION 129
3.4.4 MODEL DEVELOPMENT - PREGNANT WOMAN/MOTHER AND NEWBORN
CONCENTRATIONS
WITH MERGED HEALTHY MALE VOLUNTEERS PLASMA CONCENTRATIONS 130
3.4.4.1 STRUCTURAL AND PHARMACOSTATISTICAL SUBMODEL 131
3.4.4.2 COVARIATE ANALYSIS 133
3.4.4.3 FINAL MODEL 133
3.4.4.4 MODEL EVALUATION 136
3.4.5 MODEL COMPARISON 137
3.4.6 SIMULATION OF DIFFERENT DOSING REGIMENS FOR NEWBORNS 137
4 DISCUSSION 143
4.1 PROJECT I: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - PREGNANT
WOMEN/MOTHERS 143
4.2 PROJECT II: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - NEWBORNS
148
4.2.1 POPULATION PHARMACOKINETIC MODEL DEVELOPMENT 148
4.2.2 SIMULATIONS OF DIFFERENT DOSING REGIMENS IN DEPENDENCY OF BIRTH
TIMES 150
4.3 PROJECT III: PHARMACOKINETIC INVESTIGATION OF NEVIRAPINE - HEALTHY
MALE VOLUNTEERS 155
4.4 PROJECT IV: INTEGRATED PHARMACOKINETIC MODELS USING DATA/KNOWLEDGE
FROM THE
DIFFERENT POPULATIONS 158
4.4.1 POPULATION PHARMACOKINETIC MODEL DEVELOPMENT 158
4.4.1.1 COMPARISON OF PK PARAMETER ESTIMATES OF PREGNANT WOMEN/MOTHERS
AND
NEWBORNS OBTAINED FROM THE FINAL INTEGRATED PK MODEL 160
4.4.1.2 COMPARISON OF PK PARAMETER ESTIMATES OF NEWBORNS OBTAINED FROM
DIFFERENT
PK MODELS 162
4.4.2 SIMULATION OF DIFFERENT DOSING REGIMENS FOR NEWBORNS 162
5 CONCLUSION AND PERSPECTIVES 168
VIII
IMAGE 5
TABLE OF CONTENTS
6 ABSTRACT 171
7 ZUSAMMENFASSUNG 172
8 BIBLIOGRAPHY 173
I X
|
| any_adam_object | 1 |
| author | Frank, Monika 1978- |
| author_GND | (DE-588)1028602316 |
| author_facet | Frank, Monika 1978- |
| author_role | aut |
| author_sort | Frank, Monika 1978- |
| author_variant | m f mf |
| building | Verbundindex |
| bvnumber | BV040610762 |
| ctrlnum | (OCoLC)864611033 (DE-599)DNB1027506380 |
| dewey-full | 616.9792061 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 616 - Diseases |
| dewey-raw | 616.9792061 |
| dewey-search | 616.9792061 |
| dewey-sort | 3616.9792061 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| format | Thesis Book |
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| genre | (DE-588)4113937-9 Hochschulschrift gnd-content |
| genre_facet | Hochschulschrift |
| id | DE-604.BV040610762 |
| illustrated | Illustrated |
| indexdate | 2024-07-10T00:27:16Z |
| institution | BVB |
| isbn | 9783862473113 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-025438331 |
| oclc_num | 864611033 |
| open_access_boolean | |
| owner | DE-188 |
| owner_facet | DE-188 |
| physical | XIII, 193 S. graph. Darst. |
| publishDate | 2012 |
| publishDateSearch | 2012 |
| publishDateSort | 2012 |
| publisher | <<Der>> Andere Verlag |
| record_format | marc |
| spelling | Frank, Monika 1978- Verfasser (DE-588)1028602316 aut Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries Monika Frank Uelvesbüll <<Der>> Andere Verlag 2012 XIII, 193 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Zugl.: Berlin, Freie Univ., Diss., 2012 Mutter (DE-588)4040949-1 gnd rswk-swf Fetus (DE-588)4016957-1 gnd rswk-swf Schwangerschaft (DE-588)4053724-9 gnd rswk-swf Nevirapin (DE-588)1069149241 gnd rswk-swf HIV (DE-588)4200792-6 gnd rswk-swf Krankheitsübertragung (DE-588)4384937-4 gnd rswk-swf Prävention (DE-588)4076308-0 gnd rswk-swf Muttermilch (DE-588)4040959-4 gnd rswk-swf Neugeborenes (DE-588)4041781-5 gnd rswk-swf (DE-588)4113937-9 Hochschulschrift gnd-content Schwangerschaft (DE-588)4053724-9 s HIV (DE-588)4200792-6 s Fetus (DE-588)4016957-1 s Krankheitsübertragung (DE-588)4384937-4 s Prävention (DE-588)4076308-0 s Nevirapin (DE-588)1069149241 s DE-604 Mutter (DE-588)4040949-1 s Neugeborenes (DE-588)4041781-5 s Muttermilch (DE-588)4040959-4 s DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=025438331&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Frank, Monika 1978- Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries Mutter (DE-588)4040949-1 gnd Fetus (DE-588)4016957-1 gnd Schwangerschaft (DE-588)4053724-9 gnd Nevirapin (DE-588)1069149241 gnd HIV (DE-588)4200792-6 gnd Krankheitsübertragung (DE-588)4384937-4 gnd Prävention (DE-588)4076308-0 gnd Muttermilch (DE-588)4040959-4 gnd Neugeborenes (DE-588)4041781-5 gnd |
| subject_GND | (DE-588)4040949-1 (DE-588)4016957-1 (DE-588)4053724-9 (DE-588)1069149241 (DE-588)4200792-6 (DE-588)4384937-4 (DE-588)4076308-0 (DE-588)4040959-4 (DE-588)4041781-5 (DE-588)4113937-9 |
| title | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries |
| title_auth | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries |
| title_exact_search | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries |
| title_full | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries Monika Frank |
| title_fullStr | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries Monika Frank |
| title_full_unstemmed | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries Monika Frank |
| title_short | Population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent HIV-1 transmission in resource constrained countries |
| title_sort | population pharmacokinetic modelling and simulation of nevirapine in pregnant women and newborns for dosing strategies to prevent hiv 1 transmission in resource constrained countries |
| topic | Mutter (DE-588)4040949-1 gnd Fetus (DE-588)4016957-1 gnd Schwangerschaft (DE-588)4053724-9 gnd Nevirapin (DE-588)1069149241 gnd HIV (DE-588)4200792-6 gnd Krankheitsübertragung (DE-588)4384937-4 gnd Prävention (DE-588)4076308-0 gnd Muttermilch (DE-588)4040959-4 gnd Neugeborenes (DE-588)4041781-5 gnd |
| topic_facet | Mutter Fetus Schwangerschaft Nevirapin HIV Krankheitsübertragung Prävention Muttermilch Neugeborenes Hochschulschrift |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=025438331&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT frankmonika populationpharmacokineticmodellingandsimulationofnevirapineinpregnantwomenandnewbornsfordosingstrategiestopreventhiv1transmissioninresourceconstrainedcountries |