Pharmaceutical toxicology: safety sciences of drugs
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
London [u.a.]
Pharmaceutical Press
2006
|
| Ausgabe: | 1. publ. |
| Schriftenreihe: | ULLA postgraduate pharmacy series
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVIII, 257 S. Ill., graph. Darst. |
| ISBN: | 0853695938 9780853695936 |
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| 250 | |a 1. publ. | ||
| 264 | 1 | |a London [u.a.] |b Pharmaceutical Press |c 2006 | |
| 300 | |a XVIII, 257 S. |b Ill., graph. Darst. | ||
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| 650 | 4 | |a Toxicity testing | |
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Datensatz im Suchindex
| _version_ | 1804136242112102400 |
|---|---|
| adam_text | ULLA postgraduate pharmacy series xi
Preface xiii
About the editors xv
Contributors xvii
1 General toxicology 1
Björn Hellman
The concept of toxicity is not easily defined 1
Each drug has a unique toxicological profile 3
Is it only the dose that makes the poison? 3
Drugs can induce both immediate and delayed toxicity 5
Bioavailability and toxicokinetics: two important factors for
systemic toxicity 6
Dose response and thresholds: fundamental concepts in
toxicology 12
Toxicity testing is necessary for hazard identification and safety
assessment 21
Margins of safety 25
Studies on general toxicity 26
Studies on various lypes of specific adverse health effects 29
Toxicodynamics: there are many different mechanisms of
toxicity 35
The evaluation of toxicity dato is not always straightforward 36
Conclusion 38
Further reading 39
2 Drug metabolism: inactivarion and bioactivarion of
xenobiotics 41
Gerard J Mulder
General introduction 41
Phase 1 metabolism 44
Phase 2 reactions (conjugations) 53
Choice of animal species for drug development 60
Stereoisomers 60
Polymorphisms and genetic Variation 61
Bioactivation to toxic metabolites and idiosyncratic reactions 61
Drug interactions: biotransformation 65
Further reading 66
3 Molecular and cellular mechanisms of toxicity 67
J Fred Nagelkerke and Bob van de Water
Molecular mechanisms of toxicity 68
Cellular dysfunction 70
Cell destruction 75
Cellular responses to injury: stress kinases and molecular
chaperones 80
Switch points between cell survival and apoptosis or necrosis 81
Further reading 81
4 Teratology 83
Lennart Dencker and Bengt R Danielsson
Reproductive toxicology in adults 83
Teratogenesis 85
General principles of teratology 87
Factors to consider for human relevance in teratogenesis 88
Pregnancy labelling for drugs 89
Some examples of drug induced teratogenicity 90
Conclusion 104
Further reading 104
5 Genotoxicity 105
Björn Hellman
Genotoxicants, mutagens, clastogens and aneugens 106
End points for evaluating potential genotoxicity 107
Short term tests for genotoxicity 1 14
An important issue in the safety evaluation of drugs: threshold
doses or not? 118
High fidelity DNA repair protection 1 19
Genotoxic agents and genetic disease 1 20
Conclusion 120
Furfher reading 121
6 Carcinogenicity of drugs 123
Gerard J Mulder
Benign and malignant tumours and their classification 125
Mechanisms of carcinogenicity: initiation, promotion and
progression 127
When is a carcinogenicity study required for a medicinal
product? 128
Assessment of the potential carcinogenicity of drugs 1 29
How can the carcinogenic action of a drug be discovered in
humans? 134
Further reading 1 35
7 Liver toxicity 137
J Fred Nagelkerke
Anatomy of the liver 137
Functions of the liver 139
Types of liver toxicity 142
Assessment of liver toxicity: biomarkers and diagnostics 145
Some examples of hepatotoxic drugs 146
Further reading 148
8 Kidney toxicity 149
Bob van de Water
Renal structure and function 149
Conditions that determine kidney toxicity 151
Types and consequences of renal cell injury 153
Clinical markers of renal failure 154
Repair processes related to renal injury 155
In vitro modeis for the study of nephrotoxicity 156
Examples of renal toxicity caused by therapeutics 157
Further reading 160
9 Toxicity in the respiratory System 161
Eva Brittebo
Structure and function of the respiratory System 161
Factors contributing to respiratory toxicity 163
Toxicant induced responses of the respiratory System 166
Methods for studying toxicity to the respiratory System 169
Respiratory System toxicants 170
Further reading 175
10 Immunofoxicify 177
Camilla Svensson
The immune System 177
Immunosuppression 178
Immune enhancement 179
Hypersensitivity 179
Autoimmunity 186
Examples of immunomodulating drugs 1 88
Immunotoxicity testing of drugs 190
Further reading 192
11 Clinical ioxicology 193
Hans Persson
What is clinical toxicology? 193
General aspects 194
Management of drug overdose 197
Special poisonings 204
Conclusion 207
Further reading 208
12 Safety assessment of pharmaceuticals:
regulaiory aspects 209
Jan Willem van der Laan
European legislation in a global environment 209
Good Laboratory Practice 210
The Clinical Trial Directive 21 1
Marketing applications: formatand procedures 212
Assessment of safety is always carried out in relation to
therapeutic efficacy 213
Assessment of safety requires extrapolation from animal studies
to human effects and exposure 215
Safety assessment is a stepwise process 215
Safety studies required to support first use in humans 21 8
Safety studies required to support further clinical trials and
marketing authorisation 219
Specific populations 220
Specific products 222
Predictive value of animal studies 226
Post marketing safety assessment 227
Information resources 227
13 Pharmacovigilance 229
Sten Olsson and Ronald Meyboom
Adverse reactions and other drug related problems 230
Epidemiology of adverse drug reactions and spontaneous
reporting 232
Data assessment 233
Case causalily assessment 233
From data to Information 235
Signal detection 235
Addressing the evidence in and importance of a Signal 236
Users of data 237
Strengths and weaknesses of spontaneous reporting 237
Other methods in pharmacovigilance 239
International pharmacovigilance and the WHO Collaborating
Centre for International Pharmacovigilance in Uppsala 240
Other forms of international collaboration: EudraVigilance 240
Communicating drug safety information 241
Further reading 241
Information resources 241
Index 243
|
| adam_txt |
ULLA postgraduate pharmacy series xi
Preface xiii
About the editors xv
Contributors xvii
1 General toxicology 1
Björn Hellman
The concept of toxicity is not easily defined 1
Each drug has a unique toxicological profile 3
Is it only the 'dose' that makes the poison? 3
Drugs can induce both immediate and delayed toxicity 5
Bioavailability and toxicokinetics: two important factors for
systemic toxicity 6
Dose response and thresholds: fundamental concepts in
toxicology 12
Toxicity testing is necessary for hazard identification and safety
assessment 21
Margins of safety 25
Studies on general toxicity 26
Studies on various lypes of specific adverse health effects 29
Toxicodynamics: there are many different mechanisms of
toxicity 35
The evaluation of toxicity dato is not always straightforward 36
Conclusion 38
Further reading 39
2 Drug metabolism: inactivarion and bioactivarion of
xenobiotics 41
Gerard J Mulder
General introduction 41
Phase 1 metabolism 44
Phase 2 reactions (conjugations) 53
Choice of animal species for drug development 60
Stereoisomers 60
Polymorphisms and genetic Variation 61
Bioactivation to toxic metabolites and idiosyncratic reactions 61
Drug interactions: biotransformation 65
Further reading 66
3 Molecular and cellular mechanisms of toxicity 67
J Fred Nagelkerke and Bob van de Water
Molecular mechanisms of toxicity 68
Cellular dysfunction 70
Cell destruction 75
Cellular responses to injury: stress kinases and molecular
chaperones 80
Switch points between cell survival and apoptosis or necrosis 81
Further reading 81
4 Teratology 83
Lennart Dencker and Bengt R Danielsson
Reproductive toxicology in adults 83
Teratogenesis 85
General principles of teratology 87
Factors to consider for human relevance in teratogenesis 88
Pregnancy labelling for drugs 89
Some examples of drug induced teratogenicity 90
Conclusion 104
Further reading 104
5 Genotoxicity 105
Björn Hellman
Genotoxicants, mutagens, clastogens and aneugens 106
End points for evaluating potential genotoxicity 107
Short term tests for genotoxicity 1 14
An important issue in the safety evaluation of drugs: threshold
doses or not? 118
High fidelity DNA repair protection 1 19
Genotoxic agents and genetic disease 1 20
Conclusion 120
Furfher reading 121
6 Carcinogenicity of drugs 123
Gerard J Mulder
Benign and malignant tumours and their classification 125
Mechanisms of carcinogenicity: initiation, promotion and
progression 127
When is a carcinogenicity study required for a medicinal
product? 128
Assessment of the potential carcinogenicity of drugs 1 29
How can the carcinogenic action of a drug be discovered in
humans? 134
Further reading 1 35
7 Liver toxicity 137
J Fred Nagelkerke
Anatomy of the liver 137
Functions of the liver 139
Types of liver toxicity 142
Assessment of liver toxicity: biomarkers and diagnostics 145
Some examples of hepatotoxic drugs 146
Further reading 148
8 Kidney toxicity 149
Bob van de Water
Renal structure and function 149
Conditions that determine kidney toxicity 151
Types and consequences of renal cell injury 153
Clinical markers of renal failure 154
Repair processes related to renal injury 155
In vitro modeis for the study of nephrotoxicity 156
Examples of renal toxicity caused by therapeutics 157
Further reading 160
9 Toxicity in the respiratory System 161
Eva Brittebo
Structure and function of the respiratory System 161
Factors contributing to respiratory toxicity 163
Toxicant induced responses of the respiratory System 166
Methods for studying toxicity to the respiratory System 169
Respiratory System toxicants 170
Further reading 175
10 Immunofoxicify 177
Camilla Svensson
The immune System 177
Immunosuppression 178
Immune enhancement 179
Hypersensitivity 179
Autoimmunity 186
Examples of immunomodulating drugs 1 88
Immunotoxicity testing of drugs 190
Further reading 192
11 Clinical ioxicology 193
Hans Persson
What is clinical toxicology? 193
General aspects 194
Management of drug overdose 197
Special poisonings 204
Conclusion 207
Further reading 208
12 Safety assessment of pharmaceuticals:
regulaiory aspects 209
Jan Willem van der Laan
European legislation in a global environment 209
Good Laboratory Practice 210
The Clinical Trial Directive 21 1
Marketing applications: formatand procedures 212
Assessment of safety is always carried out in relation to
therapeutic efficacy 213
Assessment of safety requires extrapolation from animal studies
to human effects and exposure 215
Safety assessment is a stepwise process 215
Safety studies required to support first use in humans 21 8
Safety studies required to support further clinical trials and
marketing authorisation 219
Specific populations 220
Specific products 222
Predictive value of animal studies 226
Post marketing safety assessment 227
Information resources 227
13 Pharmacovigilance 229
Sten Olsson and Ronald Meyboom
Adverse reactions and other drug related problems 230
Epidemiology of adverse drug reactions and spontaneous
reporting 232
Data assessment 233
Case causalily assessment 233
From data to Information 235
Signal detection 235
Addressing the evidence in and importance of a Signal 236
Users of data 237
Strengths and weaknesses of spontaneous reporting 237
Other methods in pharmacovigilance 239
International pharmacovigilance and the WHO Collaborating
Centre for International Pharmacovigilance in Uppsala 240
Other forms of international collaboration: EudraVigilance 240
Communicating drug safety information 241
Further reading 241
Information resources 241
Index 243 |
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| spelling | Pharmaceutical toxicology safety sciences of drugs ed. by Gerard J. Mulder ... 1. publ. London [u.a.] Pharmaceutical Press 2006 XVIII, 257 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier ULLA postgraduate pharmacy series Arzneimittelschaden Arzneimittelsicherheit Drugs - Physiological effect Drugs - Toxicology Toxicity testing Toxicology Mulder, Gerard J. Sonstige oth HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015458398&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Pharmaceutical toxicology safety sciences of drugs Arzneimittelschaden Arzneimittelsicherheit Drugs - Physiological effect Drugs - Toxicology Toxicity testing Toxicology |
| title | Pharmaceutical toxicology safety sciences of drugs |
| title_auth | Pharmaceutical toxicology safety sciences of drugs |
| title_exact_search | Pharmaceutical toxicology safety sciences of drugs |
| title_exact_search_txtP | Pharmaceutical toxicology safety sciences of drugs |
| title_full | Pharmaceutical toxicology safety sciences of drugs ed. by Gerard J. Mulder ... |
| title_fullStr | Pharmaceutical toxicology safety sciences of drugs ed. by Gerard J. Mulder ... |
| title_full_unstemmed | Pharmaceutical toxicology safety sciences of drugs ed. by Gerard J. Mulder ... |
| title_short | Pharmaceutical toxicology |
| title_sort | pharmaceutical toxicology safety sciences of drugs |
| title_sub | safety sciences of drugs |
| topic | Arzneimittelschaden Arzneimittelsicherheit Drugs - Physiological effect Drugs - Toxicology Toxicity testing Toxicology |
| topic_facet | Arzneimittelschaden Arzneimittelsicherheit Drugs - Physiological effect Drugs - Toxicology Toxicity testing Toxicology |
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