Dermal absorption:
Gespeichert in:
| Hauptverfasser: | , , |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Geneva
World Health Organization
2006
|
| Ausgabe: | 1. draft |
| Schriftenreihe: | Environmental health criteria
235 |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | 197 S. graph. Darst. |
| ISBN: | 9789241572354 9241572353 |
Internformat
MARC
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| 100 | 1 | |a Kielhorn, Janet |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Dermal absorption |c prep. by Janet Kielhorn, Stephanie Melching-Kollmuß, and Inge Mangelsdorf |
| 250 | |a 1. draft | ||
| 264 | 1 | |a Geneva |b World Health Organization |c 2006 | |
| 300 | |a 197 S. |b graph. Darst. | ||
| 336 | |b txt |2 rdacontent | ||
| 337 | |b n |2 rdamedia | ||
| 338 | |b nc |2 rdacarrier | ||
| 490 | 1 | |a Environmental health criteria |v 235 | |
| 650 | 7 | |a Absorptie |2 gtt | |
| 650 | 4 | |a Absorption cutanée | |
| 650 | 4 | |a Agents dermatologiques - Toxicologie | |
| 650 | 4 | |a Dermatotoxicologie | |
| 650 | 7 | |a Huid |2 gtt | |
| 650 | 7 | |a Toxicologie |2 gtt | |
| 650 | 4 | |a Évaluation du risque | |
| 650 | 4 | |a Environmental Exposure | |
| 650 | 4 | |a Hazardous substances |x Risk assessment | |
| 650 | 4 | |a Risk Assessment | |
| 650 | 4 | |a Skin Absorption |x physiology | |
| 650 | 4 | |a Skin absorption |x Measurement | |
| 650 | 4 | |a Skin absorption |x Testing | |
| 650 | 0 | 7 | |a Toxizität |0 (DE-588)4078372-8 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Hautresorption |0 (DE-588)4023861-1 |2 gnd |9 rswk-swf |
| 650 | 0 | 7 | |a Gesundheitsschädlicher Stoff |0 (DE-588)4020767-5 |2 gnd |9 rswk-swf |
| 689 | 0 | 0 | |a Gesundheitsschädlicher Stoff |0 (DE-588)4020767-5 |D s |
| 689 | 0 | 1 | |a Hautresorption |0 (DE-588)4023861-1 |D s |
| 689 | 0 | 2 | |a Toxizität |0 (DE-588)4078372-8 |D s |
| 689 | 0 | |5 DE-604 | |
| 700 | 1 | |a Melching-Kollmuß, Stephanie |e Verfasser |4 aut | |
| 700 | 1 | |a Mangelsdorf, Inge |e Verfasser |4 aut | |
| 830 | 0 | |a Environmental health criteria |v 235 |w (DE-604)BV000011459 |9 235 | |
| 856 | 4 | 2 | |m HBZ Datenaustausch |q application/pdf |u http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015657197&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |3 Inhaltsverzeichnis |
| 999 | |a oai:aleph.bib-bvb.de:BVB01-015657197 | ||
Datensatz im Suchindex
| _version_ | 1804136528249618432 |
|---|---|
| adam_text | CONTENTS
ENVIRONMENTAL HEALTH CRITERIA FOR
DERMAL ABSORPTION
PREAMBLE x
ACRONYMS AND ABBREVIATIONS xvii
1. SUMMARY 1
2. INTRODUCTION AND DEFINITIONS 6
2.1 Scope of the document 6
2.2 Definition of dermal absorption g
2.3 Factors influencing dermal absorption 8
3. SKIN STRUCTURE AND FUNCTION 10
3.1 Functions of the skin 10
3.1.1 Barrier function 10
3.1.2 Temperature control 11
3.1.3 Defence and repair 11
3.2 Skin structure 12
3.2.1 Epidermis 12
3.2.2 Dermis 16
3.2.3 Skin appendages 16
3.3 The transport of chemicals through the skin 17
3.4 Variability in skin permeability 17
3.4.1 Species 17
3.4.2 Age, sex, and race 18
3.4.3 Anatomical site 19
3.4.4 Skin condition 19
3.4.5 Temperature and blood flow rate 19
3.4.6 Hydration 20
3.5 Reservoir effects 20
Hi
EHC 235: Dermal Absorption
4. SKIN TRANSPORT MECHANISMS AND
THEORETICAL CONCEPTS 23
4.1 Transport through the skin 23
4.2 Theoretical aspects of diffusion 23
4.3 Physicochemical factors affecting skin permeation 26
4.3.1 Physical state 27
4.3.2 Molecular size/molecular weight 27
4.3.3 Maximum flux 28
4.3.4 Ionization 28
4.3.5 Binding properties 29
4.4 Concepts of finite and infinite dose 29
5. METABOLISM IN THE SKIN 32
5.1 The drug metabolizing systems of the skin 33
5.2 Methodology for evaluating skin metabolism in
in vitro systems 35
5.3 Effects of skin metabolism 35
5.4 Importance of metabolism for percutaneous
absorption 36
6. IN VITRO TESTS FOR DERMAL ABSORPTION 38
6.1 Test guidelines 38
6.2 Principles of the standard in vitro tests using skin
samples 39
6.2.1 Test chambers 39
6.2.1.1 Static diffusion cells 40
6.2.1.2 Flow through cells 40
6.2.1.3 Comparison of different in vitro cell
systems 42
6.2.2 Finite/infinite dosing 43
6.2.3 Skin preparations 44
6.2.3.1 Choice of skin 44
6.2.3.2 Preparation of tissue samples 45
6.2.3.3 Checking of barrier integrity 46
6.2.4 Application of test substance 47
6.2.4.1 Test substance 47
6.2.4.2 Vehicle 48
6.2.4.3 Receptor fluid 48
6.2.4.4 Application dose levels 50
iv
Contents
6.2.5 Duration of exposure and sampling time 50
6.2.6 Evaluation of the results 50
6.2.6.1 Dermal absorption results after finite
dosing 51
6.2.6.2 Dermal absorption results after infinite
dosing 52
6.3 Other in vitro methods 52
6.3.1 Artificial skin 52
6.3.2 Tape stripping technique in vitro 52
6.4 Examination of skin reservoir characteristics 53
6.5 Experimental factors affecting dermal absorption
in vitro 54
6.5.1 Species differences 54
6.5.2 Temperature 55
6.5.3 Occlusion 56
6.5.4 Thickness of skin 56
6.5.5 Further observations on application vehicle
effects 58
7. IN VIVO TESTS FOR DERMAL ABSORPTION 60
7.1 Laboratory animal studies 60
7.1.1 Test guidelines for laboratory animal studies 61
7.1.2 Principles of the standard in vivo tests 61
7.1.2.1 Preparation of the application site 62
7.1.2.2 Dose levels 62
7.1.2.3 Application of the test substance to the
skin 62
7.1.2.4 Duration of exposure 63
7.1.2.5 Sacrifice and time of termination 63
7.1.2.6 Evaluation of the results 64
7.2 Studies with human volunteers 65
7.2.1 Assessment using plasma, excreta, and breath
analysis 66
7.2.1.1 Methodology 66
7.2.1.2 Examples of in vivo human volunteer
studies 66
7.2.1.3 Biomonitoring of occupational
exposure 67
7.2.2 Cutaneous microdialysis 68
7.2.3 Tape stripping 70
v
EHC 235: Dermal Absorption
7.3 Other methods 73
7.3.1 Whole body autoradiography 73
7.3.2 Skin biopsy 73
7.4 Factors affecting dermal absorption in vivo 74
7.4.1 Species, strain, and sex 74
7.4.2 Age 75
7.4.3 Anatomical site 75
7.4.4 Type of application and vehicle 77
7.4.5 Temperature and humidity conditions 78
8. COMPARATIVE STUDIES 79
8.1 Comparison between in vitro and in vivo skin
absorption results 79
8.2 Inter and intralaboratory variation in in vitro
percutaneous absorption methodology 84
9. DATA COLLECTIONS 86
9.1 Data sets from homologous or closely related
molecules 86
9.2 Flynn data set 87
9.3 Expanded permeability coefficient data sets 88
9.4 EDETOX database 88
9.5 Maximum flux databases 89
10. ESTIMATION/PREDICTION OF DERMAL
PENETRATION 90
10.1 QSAR analysis 91
10.1.1 Prerequisites for QSPeR analysis 91
10.1.2 Historical overview 92
10.1.2.1 QSPeRs for skin permeability
prior to the 1990s 92
10.1.2.2 The Flynn (1990) data set and
subsequent analyses 93
10.1.2.3 Other data sets 97
10.1.3 Other approaches to QSPeR 97
10.1.4 Variability of data and its relevance
for QSPeRs 98
10.1.5 Statistical analysis (linear vs non¬
linear) methods 98
vi
Contents
10.1.6 Selection of chemicals for further
tests on dermal penetration 98
10.1.7 Applicability domain for QSPeR 99
10.1.8 Maximum fluxes 99
10.1.9 Rules as an alternative to QSPeRs 100
10.2 Mathematical modelling 100
10.3 Mathematical pharmacokinetic models of
percutaneous penetration 103
11. USE OF DERMAL PENETRATION STUDIES IN RISK
ASSESSMENT 105
11.1 Decision making process for setting dermal
absorption values 106
11.1.1 Default values 107
11.1.2 Measured values 108
11.1.3 Values from mathematical skin permeation
models (e.g. QSARs/QSPeRs) 110
11.2 Use of relative absorption values versus flux (and
their derived permeability coefficients) 110
11.3 Other topics related to risk assessment 111
12. CONTROVERSIAL TOPICS IN THE ASSESSMENT OF
DERMAL ABSORPTION 112
12.1 QSARs/QSPeRs 112
12.2 Reduction of intralaboratory/interlaboratory
variation 112
12.3 Consequences of reservoir effect for risk assessment 113
12.4 Relevance of percutaneous measurements to data
required by risk assessors: finite and infinite
exposures 114
12.5 Single versus multiple exposure regimes 114
12.6 Barrier integrity test for skin barrier function of
human skin in skin penetration tests 115
12.7 Dermal absorption in susceptible populations 115
12.8 Skinnotation 117
12.8.1 Skin notation criteria in different countries 118
12.8.2 Quantitative approaches 119
12.8.3 New approaches 120
12.9 Dermal absorption of nanoparticles 121
vii
EHC 235: Dermal Absorption
13. CONCLUSIONS AND RECOMMENDATIONS 124
REFERENCES 127
APPENDIX 1 : GUIDELINES AND PROTOCOLS 163
APPENDIX 2: PAST AND PRESENT INITIATIVES ON
EXCHANGE OF INFORMATION AND HARMONIZATION
OF METHODOLOGY ON DERMAL ABSORPTION 170
RESUME 186
RESUMEN 192
viii
|
| adam_txt |
CONTENTS
ENVIRONMENTAL HEALTH CRITERIA FOR
DERMAL ABSORPTION
PREAMBLE x
ACRONYMS AND ABBREVIATIONS xvii
1. SUMMARY 1
2. INTRODUCTION AND DEFINITIONS 6
2.1 Scope of the document 6
2.2 Definition of dermal absorption g
2.3 Factors influencing dermal absorption 8
3. SKIN STRUCTURE AND FUNCTION 10
3.1 Functions of the skin 10
3.1.1 Barrier function 10
3.1.2 Temperature control 11
3.1.3 Defence and repair 11
3.2 Skin structure 12
3.2.1 Epidermis 12
3.2.2 Dermis 16
3.2.3 Skin appendages 16
3.3 The transport of chemicals through the skin 17
3.4 Variability in skin permeability 17
3.4.1 Species 17
3.4.2 Age, sex, and race 18
3.4.3 Anatomical site 19
3.4.4 Skin condition 19
3.4.5 Temperature and blood flow rate 19
3.4.6 Hydration 20
3.5 Reservoir effects 20
Hi
EHC 235: Dermal Absorption
4. SKIN TRANSPORT MECHANISMS AND
THEORETICAL CONCEPTS 23
4.1 Transport through the skin 23
4.2 Theoretical aspects of diffusion 23
4.3 Physicochemical factors affecting skin permeation 26
4.3.1 Physical state 27
4.3.2 Molecular size/molecular weight 27
4.3.3 Maximum flux 28
4.3.4 Ionization 28
4.3.5 Binding properties 29
4.4 Concepts of finite and infinite dose 29
5. METABOLISM IN THE SKIN 32
5.1 The drug metabolizing systems of the skin 33
5.2 Methodology for evaluating skin metabolism in
in vitro systems 35
5.3 Effects of skin metabolism 35
5.4 Importance of metabolism for percutaneous
absorption 36
6. IN VITRO TESTS FOR DERMAL ABSORPTION 38
6.1 Test guidelines 38
6.2 Principles of the standard in vitro tests using skin
samples 39
6.2.1 Test chambers 39
6.2.1.1 Static diffusion cells 40
6.2.1.2 Flow through cells 40
6.2.1.3 Comparison of different in vitro cell
systems 42
6.2.2 Finite/infinite dosing 43
6.2.3 Skin preparations 44
6.2.3.1 Choice of skin 44
6.2.3.2 Preparation of tissue samples 45
6.2.3.3 Checking of barrier integrity 46
6.2.4 Application of test substance 47
6.2.4.1 Test substance 47
6.2.4.2 Vehicle 48
6.2.4.3 Receptor fluid 48
6.2.4.4 Application dose levels 50
iv
Contents
6.2.5 Duration of exposure and sampling time 50
6.2.6 Evaluation of the results 50
6.2.6.1 Dermal absorption results after finite
dosing 51
6.2.6.2 Dermal absorption results after infinite
dosing 52
6.3 Other in vitro methods 52
6.3.1 Artificial skin 52
6.3.2 Tape stripping technique in vitro 52
6.4 Examination of skin reservoir characteristics 53
6.5 Experimental factors affecting dermal absorption
in vitro 54
6.5.1 Species differences 54
6.5.2 Temperature 55
6.5.3 Occlusion 56
6.5.4 Thickness of skin 56
6.5.5 Further observations on application vehicle
effects 58
7. IN VIVO TESTS FOR DERMAL ABSORPTION 60
7.1 Laboratory animal studies 60
7.1.1 Test guidelines for laboratory animal studies 61
7.1.2 Principles of the standard in vivo tests 61
7.1.2.1 Preparation of the application site 62
7.1.2.2 Dose levels 62
7.1.2.3 Application of the test substance to the
skin 62
7.1.2.4 Duration of exposure 63
7.1.2.5 Sacrifice and time of termination 63
7.1.2.6 Evaluation of the results 64
7.2 Studies with human volunteers 65
7.2.1 Assessment using plasma, excreta, and breath
analysis 66
7.2.1.1 Methodology 66
7.2.1.2 Examples of in vivo human volunteer
studies 66
7.2.1.3 Biomonitoring of occupational
exposure 67
7.2.2 Cutaneous microdialysis 68
7.2.3 Tape stripping 70
v
EHC 235: Dermal Absorption
7.3 Other methods 73
7.3.1 Whole body autoradiography 73
7.3.2 Skin biopsy 73
7.4 Factors affecting dermal absorption in vivo 74
7.4.1 Species, strain, and sex 74
7.4.2 Age 75
7.4.3 Anatomical site 75
7.4.4 Type of application and vehicle 77
7.4.5 Temperature and humidity conditions 78
8. COMPARATIVE STUDIES 79
8.1 Comparison between in vitro and in vivo skin
absorption results 79
8.2 Inter and intralaboratory variation in in vitro
percutaneous absorption methodology 84
9. DATA COLLECTIONS 86
9.1 Data sets from homologous or closely related
molecules 86
9.2 Flynn data set 87
9.3 Expanded permeability coefficient data sets 88
9.4 EDETOX database 88
9.5 Maximum flux databases 89
10. ESTIMATION/PREDICTION OF DERMAL
PENETRATION 90
10.1 QSAR analysis 91
10.1.1 Prerequisites for QSPeR analysis 91
10.1.2 Historical overview 92
10.1.2.1 QSPeRs for skin permeability
prior to the 1990s 92
10.1.2.2 The Flynn (1990) data set and
subsequent analyses 93
10.1.2.3 Other data sets 97
10.1.3 Other approaches to QSPeR 97
10.1.4 Variability of data and its relevance
for QSPeRs 98
10.1.5 Statistical analysis (linear vs non¬
linear) methods 98
vi
Contents
10.1.6 Selection of chemicals for further
tests on dermal penetration 98
10.1.7 Applicability domain for QSPeR 99
10.1.8 Maximum fluxes 99
10.1.9 Rules as an alternative to QSPeRs 100
10.2 Mathematical modelling 100
10.3 Mathematical pharmacokinetic models of
percutaneous penetration 103
11. USE OF DERMAL PENETRATION STUDIES IN RISK
ASSESSMENT 105
11.1 Decision making process for setting dermal
absorption values 106
11.1.1 Default values 107
11.1.2 Measured values 108
11.1.3 Values from mathematical skin permeation
models (e.g. QSARs/QSPeRs) 110
11.2 Use of relative absorption values versus flux (and
their derived permeability coefficients) 110
11.3 Other topics related to risk assessment 111
12. CONTROVERSIAL TOPICS IN THE ASSESSMENT OF
DERMAL ABSORPTION 112
12.1 QSARs/QSPeRs 112
12.2 Reduction of intralaboratory/interlaboratory
variation 112
12.3 Consequences of reservoir effect for risk assessment 113
12.4 Relevance of percutaneous measurements to data
required by risk assessors: finite and infinite
exposures 114
12.5 Single versus multiple exposure regimes 114
12.6 Barrier integrity test for skin barrier function of
human skin in skin penetration tests 115
12.7 Dermal absorption in susceptible populations 115
12.8 Skinnotation 117
12.8.1 Skin notation criteria in different countries 118
12.8.2 Quantitative approaches 119
12.8.3 New approaches 120
12.9 Dermal absorption of nanoparticles 121
vii
EHC 235: Dermal Absorption
13. CONCLUSIONS AND RECOMMENDATIONS 124
REFERENCES 127
APPENDIX 1 : GUIDELINES AND PROTOCOLS 163
APPENDIX 2: PAST AND PRESENT INITIATIVES ON
EXCHANGE OF INFORMATION AND HARMONIZATION
OF METHODOLOGY ON DERMAL ABSORPTION 170
RESUME 186
RESUMEN 192
viii |
| any_adam_object | 1 |
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| author | Kielhorn, Janet Melching-Kollmuß, Stephanie Mangelsdorf, Inge |
| author_facet | Kielhorn, Janet Melching-Kollmuß, Stephanie Mangelsdorf, Inge |
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| author_sort | Kielhorn, Janet |
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| callnumber-sort | QP 288.5 |
| callnumber-subject | QP - Physiology |
| ctrlnum | (OCoLC)139749069 (DE-599)BVBBV022449291 |
| dewey-full | 615.902 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615.902 |
| dewey-search | 615.902 |
| dewey-sort | 3615.902 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| discipline_str_mv | Medizin |
| edition | 1. draft |
| format | Book |
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| id | DE-604.BV022449291 |
| illustrated | Illustrated |
| index_date | 2024-07-02T17:35:47Z |
| indexdate | 2024-07-09T20:57:50Z |
| institution | BVB |
| isbn | 9789241572354 9241572353 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-015657197 |
| oclc_num | 139749069 |
| open_access_boolean | |
| owner | DE-12 |
| owner_facet | DE-12 |
| physical | 197 S. graph. Darst. |
| publishDate | 2006 |
| publishDateSearch | 2006 |
| publishDateSort | 2006 |
| publisher | World Health Organization |
| record_format | marc |
| series | Environmental health criteria |
| series2 | Environmental health criteria |
| spelling | Kielhorn, Janet Verfasser aut Dermal absorption prep. by Janet Kielhorn, Stephanie Melching-Kollmuß, and Inge Mangelsdorf 1. draft Geneva World Health Organization 2006 197 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Environmental health criteria 235 Absorptie gtt Absorption cutanée Agents dermatologiques - Toxicologie Dermatotoxicologie Huid gtt Toxicologie gtt Évaluation du risque Environmental Exposure Hazardous substances Risk assessment Risk Assessment Skin Absorption physiology Skin absorption Measurement Skin absorption Testing Toxizität (DE-588)4078372-8 gnd rswk-swf Hautresorption (DE-588)4023861-1 gnd rswk-swf Gesundheitsschädlicher Stoff (DE-588)4020767-5 gnd rswk-swf Gesundheitsschädlicher Stoff (DE-588)4020767-5 s Hautresorption (DE-588)4023861-1 s Toxizität (DE-588)4078372-8 s DE-604 Melching-Kollmuß, Stephanie Verfasser aut Mangelsdorf, Inge Verfasser aut Environmental health criteria 235 (DE-604)BV000011459 235 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015657197&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Kielhorn, Janet Melching-Kollmuß, Stephanie Mangelsdorf, Inge Dermal absorption Environmental health criteria Absorptie gtt Absorption cutanée Agents dermatologiques - Toxicologie Dermatotoxicologie Huid gtt Toxicologie gtt Évaluation du risque Environmental Exposure Hazardous substances Risk assessment Risk Assessment Skin Absorption physiology Skin absorption Measurement Skin absorption Testing Toxizität (DE-588)4078372-8 gnd Hautresorption (DE-588)4023861-1 gnd Gesundheitsschädlicher Stoff (DE-588)4020767-5 gnd |
| subject_GND | (DE-588)4078372-8 (DE-588)4023861-1 (DE-588)4020767-5 |
| title | Dermal absorption |
| title_auth | Dermal absorption |
| title_exact_search | Dermal absorption |
| title_exact_search_txtP | Dermal absorption |
| title_full | Dermal absorption prep. by Janet Kielhorn, Stephanie Melching-Kollmuß, and Inge Mangelsdorf |
| title_fullStr | Dermal absorption prep. by Janet Kielhorn, Stephanie Melching-Kollmuß, and Inge Mangelsdorf |
| title_full_unstemmed | Dermal absorption prep. by Janet Kielhorn, Stephanie Melching-Kollmuß, and Inge Mangelsdorf |
| title_short | Dermal absorption |
| title_sort | dermal absorption |
| topic | Absorptie gtt Absorption cutanée Agents dermatologiques - Toxicologie Dermatotoxicologie Huid gtt Toxicologie gtt Évaluation du risque Environmental Exposure Hazardous substances Risk assessment Risk Assessment Skin Absorption physiology Skin absorption Measurement Skin absorption Testing Toxizität (DE-588)4078372-8 gnd Hautresorption (DE-588)4023861-1 gnd Gesundheitsschädlicher Stoff (DE-588)4020767-5 gnd |
| topic_facet | Absorptie Absorption cutanée Agents dermatologiques - Toxicologie Dermatotoxicologie Huid Toxicologie Évaluation du risque Environmental Exposure Hazardous substances Risk assessment Risk Assessment Skin Absorption physiology Skin absorption Measurement Skin absorption Testing Toxizität Hautresorption Gesundheitsschädlicher Stoff |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015657197&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV000011459 |
| work_keys_str_mv | AT kielhornjanet dermalabsorption AT melchingkollmußstephanie dermalabsorption AT mangelsdorfinge dermalabsorption |