Pharmacovigilance:
Gespeichert in:
| Format: | Buch |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Chichester [u.a.]
Wiley
2007
|
| Ausgabe: | 2. ed. |
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | XVIII, 686 S. Ill., graph. Darst. |
| ISBN: | 9780470018033 0470018038 |
Internformat
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| 245 | 1 | 0 | |a Pharmacovigilance |c ed. Ronald D. Mann ... |
| 250 | |a 2. ed. | ||
| 264 | 1 | |a Chichester [u.a.] |b Wiley |c 2007 | |
| 300 | |a XVIII, 686 S. |b Ill., graph. Darst. | ||
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| 650 | 2 | |a Pharmaceutical Preparations |a adverse effects | |
| 650 | 2 | |a Pharmacoepidemiology |a methods | |
| 650 | 2 | |a Product Surveillance, Postmarketing | |
| 650 | 2 | |a Drug Toxicity |a classification | |
| 650 | 4 | |a Pharmacoépidémiologie | |
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Datensatz im Suchindex
| _version_ | 1804136489881174016 |
|---|---|
| adam_text | Contents
Contributors
..................................................................................... ix
Preface
.......................................................................................... xv
Foreword
........................................................................................xvii
PART I. THE BASIS OF PHARMACOVIGILANCE
................................................ 1
1.
Introduction
................................................................................ 3
Ronald D. Mann and Elizabeth B. Andrews
2.
Legal Basis
- EU............................................................................ 13
Nicholas Macfarlane, Paul Brown, Caroline Moore, Claire Taylor,
Uwe Froehlich, Tanja
Barton, Olivier Banchereau and
Paola La
Licata
3.
Legal Basis
-
United States
.................................................................. 25
Jayne P. Bultena
4.
Ethical Oversight, Consent and Confidentiality
............................................... 35
Donna A. Boswell and Elizabeth B. Andrews
5.
Pharmacovigilance-Related Topics at the Level of the International Conference on
Harmonisation
.............................................................................. 51
Priya Bahri and
Panos Tsintis
6.
Periodic Safety Update Reports
.............................................................. 63
Patrice Verpillat and Mondher Toumi
7.
Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
......................... 75
Patricia M. Reed, Stuart J. Mair and Stephen Freestone
8.
Mechanisms of Adverse Drug Reactions
..................................................... 85
Munir
Pirmohamed and B. Kevin Park
9.
Micturin and
Torsades de Pointes
........................................................... 105
Richard
N.
Wild
10.
Withdrawal of Terodiline: A Tale of Two Toxicities
..........................................109
Rashmi R. Shah
11.
Nomifensine and Haemolytic Anaemia
.......................................................137
Peter D. Stonier and J. Guy Edwards
vi
CONTENTS
CONTENTS
vii
PART
II.
SIGNAL GENERATION
................................................................ 149
12.
WHO
Programme
-
Global
Monitoring
...................................................... 151
I.
Ralph Edwards
and Cecilia Biriell
13.
Medical Dictionary for Regulatory Activities (MedDRA®)
.................................... 167
Elliot Brown
14.
Regulatory Pharmacovigilance in the
EU
.................................................... 185
Priya Bahri,
Panos
Tsintis and Patrick C. Waller
15.
Spontaneous Reporting
-
UK
................................................................ 199
Sarah Davis, Bridget King and June
M. Raine
16.
Spontaneous Reporting
-
France
............................................................ 217
Nicholas Moore, Carmen Kreft-Jais and
Alban Dhanani
17.
Spontaneous Reporting in Germany
......................................................... 227
Ulrich
Hagemann
and
Norbert Paeschke
18.
Spontaneous Reporting
-
United States
...................................................... 237
David J. Graham, Syed R. Ahmad and
Toni Piazza-Hepp
19.
Statistical Methods of Signal Detection
.......................................................249
Stephen Evans
20.
Statistical Methods of Evaluating Pharmacovigilance Data
................................... 257
Bernard
Bégaud
21.
Data Mining in Pharmacovigilance: A View from the Uppsala
Monitoring Centre
.......................................................................... 265
I. Ralph Edwards, Marie
Lindauist,
Andrew Bate and G.
Niklas
Norén
22.
Pharmacovigilance in the Netherlands
....................................................... 277
Kees
van
Grootheest
and Eugene van Puijenbroek
23.
CIOMS Working Groups and their Contribution to Pharmacovigilance
...................... 287
Sue
Roden
and Trevor Gibbs
24.
РЕМ
in the UK
............................................................................. 307
SaadA.W. Shakir
25.
РЕМ
in New Zealand
....................................................................... 317
Mira
Harrison-Woolrych and David M. Coulter
26.
MEMO in the United Kingdom
..............................................................333
Douglas Steinke, Josie M.M. Evans and Thomas M.
Macdonald
27.
The General Practice Research Database: Now and the Future
............................... 341
John Parkinson, Sarah Davis and Tjeerd Van Staa
28.
Overview of North American Databases
..................................................... 349
Brian L. Strom and Judith L. Kinman
29.
Other Databases in Europe for the Analytic Evaluation of Drug Effects
.......................361
Miriam C.J.M. Sturkenboom
30.
Surveillance for Medical Devices
-
USA
..................................................... 375
Thomas P. Gross
31.
Pharmacovigilance and Risk Management in Japan
.......................................... 387
Kiyoshi Kubota and Hiroko Koyama
PART III. PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
............... 395
32.
Dermatological ADRs
....................................................................... 397
Laurence Allanore-Valeyrie and Jean-Claude Roujeau
33.
Gastrointestinal ADRs
.......................................................................407
John R. Wood and Graham A. Pipkin
34.
Haematological ADRs
.......................................................................419
Peter J. Carey
35.
Hepatic ADRs
...............................................................................429
Guruprasad P. Aithal and Christopher P. Day
36.
Ocular Side Effects of Prescription Medications
..............................................445
F.W. Fraunfelder
37.
Drug Safety in Pregnancy
...................................................................455
Christina D. Chambers and Elizabeth B. Andrews
38.
Renal Adverse Drug Reactions
.............................................................. 467
Gert
A. Verpooten
39.
Anaesthetic Adverse Drug Reactions
.........................................................475
Anita Holdcroft
40.
Pharmacovigilance in Pediatrics
.............................................................497
Solomon lyasu and M. Dianne Murphy
41.
The Cardiovascular Spectrum of Adverse Drug
Reactions
...................................................................................507
Judith Hsia, Jinping Mo, Laura Burleson and
Annlouise
R.
Assaf
42.
Drugs and the Elderly
.......................................................................515
Una Martin and Jamie J. Coleman
PART IV. KEY CURRENT TOPICS
............................................................... 533
43.
US Activities in Risk Management of Pharmaceutical
Products
....................................................................................535
Jonca Bull
44.
Risk Management
-
a European Regulatory View
............................................553
June
M. Raine
45.
The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors
for the Treatment of Depression in Children and Adolescents
................................ 559
Julie
Magno Zito
and Daniel J. Safer
46.
Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
...........................571
Annlouise
R.
Assaf, Laura E. Burleson and
Joann
E.
Manson
47.
NSAIDs
-
COX-2 Inhibitors
-
Risks and Benefits
............................................583
K. Arnold Chan and S. Christopher Jones
48.
Introduction to Pharmionics: The Vagaries in Ambulatory Patients Adherence
to Prescribed Drug Dosing Regimens, and Some of Their
Clinical and Economic Consequences
........................................................603
John Urquhart and Bernard Vrijens
PART V. LESSONS AND DIRECTIONS
.......................................................... 619
49.
Teaching and Learning Pharmacovigilance
.................................................. 621
Frank May
49b. Practical Experience in Teaching Pharmacovigilance
........................................633
Stephen Evans
viii CONTENTS
50.
Fatal
Medication Errors and Adverse Drug Reactions
-
Coroners Inquests
and Other Sources
.......................................................................... 635
R.E. Femer, S.E.
McDowell and
Α.Κ.
Cotter
51.
Pharmacogenetics and the Genetic Basis of ADRs
............................................647
Penelope K. Manasco
52.
Keynote Clinical Lessons from Pharmacovigilance
...........................................667
David H. Law son and Keith Beard
Index
............................................................................................677
|
| adam_txt |
Contents
Contributors
. ix
Preface
. xv
Foreword
.xvii
PART I. THE BASIS OF PHARMACOVIGILANCE
. 1
1.
Introduction
. 3
Ronald D. Mann and Elizabeth B. Andrews
2.
Legal Basis
- EU. 13
Nicholas Macfarlane, Paul Brown, Caroline Moore, Claire Taylor,
Uwe Froehlich, Tanja
Barton, Olivier Banchereau and
Paola La
Licata
3.
Legal Basis
-
United States
. 25
Jayne P. Bultena
4.
Ethical Oversight, Consent and Confidentiality
. 35
Donna A. Boswell and Elizabeth B. Andrews
5.
Pharmacovigilance-Related Topics at the Level of the International Conference on
Harmonisation
. 51
Priya Bahri and
Panos Tsintis
6.
Periodic Safety Update Reports
. 63
Patrice Verpillat and Mondher Toumi
7.
Non-Clinical Safety Evaluation and Adverse Events in Phase I Trials
. 75
Patricia M. Reed, Stuart J. Mair and Stephen Freestone
8.
Mechanisms of Adverse Drug Reactions
. 85
Munir
Pirmohamed and B. Kevin Park
9.
Micturin and
Torsades de Pointes
. 105
Richard
N.
Wild
10.
Withdrawal of Terodiline: A Tale of Two Toxicities
.109
Rashmi R. Shah
11.
Nomifensine and Haemolytic Anaemia
.137
Peter D. Stonier and J. Guy Edwards
vi
CONTENTS
CONTENTS
vii
PART
II.
SIGNAL GENERATION
. 149
12.
WHO
Programme
-
Global
Monitoring
. 151
I.
Ralph Edwards
and Cecilia Biriell
13.
Medical Dictionary for Regulatory Activities (MedDRA®)
. 167
Elliot Brown
14.
Regulatory Pharmacovigilance in the
EU
. 185
Priya Bahri,
Panos
Tsintis and Patrick C. Waller
15.
Spontaneous Reporting
-
UK
. 199
Sarah Davis, Bridget King and June
M. Raine
16.
Spontaneous Reporting
-
France
. 217
Nicholas Moore, Carmen Kreft-Jais and
Alban Dhanani
17.
Spontaneous Reporting in Germany
. 227
Ulrich
Hagemann
and
Norbert Paeschke
18.
Spontaneous Reporting
-
United States
. 237
David J. Graham, Syed R. Ahmad and
Toni Piazza-Hepp
19.
Statistical Methods of Signal Detection
.249
Stephen Evans
20.
Statistical Methods of Evaluating Pharmacovigilance Data
. 257
Bernard
Bégaud
21.
Data Mining in Pharmacovigilance: A View from the Uppsala
Monitoring Centre
. 265
I. Ralph Edwards, Marie
Lindauist,
Andrew Bate and G.
Niklas
Norén
22.
Pharmacovigilance in the Netherlands
. 277
Kees
van
Grootheest
and Eugene van Puijenbroek
23.
CIOMS Working Groups and their Contribution to Pharmacovigilance
. 287
Sue
Roden
and Trevor Gibbs
24.
РЕМ
in the UK
. 307
SaadA.W. Shakir
25.
РЕМ
in New Zealand
. 317
Mira
Harrison-Woolrych and David M. Coulter
26.
MEMO in the United Kingdom
.333
Douglas Steinke, Josie M.M. Evans and Thomas M.
Macdonald
27.
The General Practice Research Database: Now and the Future
. 341
John Parkinson, Sarah Davis and Tjeerd Van Staa
28.
Overview of North American Databases
. 349
Brian L. Strom and Judith L. Kinman
29.
Other Databases in Europe for the Analytic Evaluation of Drug Effects
.361
Miriam C.J.M. Sturkenboom
30.
Surveillance for Medical Devices
-
USA
. 375
Thomas P. Gross
31.
Pharmacovigilance and Risk Management in Japan
. 387
Kiyoshi Kubota and Hiroko Koyama
PART III. PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
. 395
32.
Dermatological ADRs
. 397
Laurence Allanore-Valeyrie and Jean-Claude Roujeau
33.
Gastrointestinal ADRs
.407
John R. Wood and Graham A. Pipkin
34.
Haematological ADRs
.419
Peter J. Carey
35.
Hepatic ADRs
.429
Guruprasad P. Aithal and Christopher P. Day
36.
Ocular Side Effects of Prescription Medications
.445
F.W. Fraunfelder
37.
Drug Safety in Pregnancy
.455
Christina D. Chambers and Elizabeth B. Andrews
38.
Renal Adverse Drug Reactions
. 467
Gert
A. Verpooten
39.
Anaesthetic Adverse Drug Reactions
.475
Anita Holdcroft
40.
Pharmacovigilance in Pediatrics
.497
Solomon lyasu and M. Dianne Murphy
41.
The Cardiovascular Spectrum of Adverse Drug
Reactions
.507
Judith Hsia, Jinping Mo, Laura Burleson and
Annlouise
R.
Assaf
42.
Drugs and the Elderly
.515
Una Martin and Jamie J. Coleman
PART IV. KEY CURRENT TOPICS
. 533
43.
US Activities in Risk Management of Pharmaceutical
Products
.535
Jonca Bull
44.
Risk Management
-
a European Regulatory View
.553
June
M. Raine
45.
The Efficacy and Safety of Selective Serotonin Reuptake Inhibitors
for the Treatment of Depression in Children and Adolescents
. 559
Julie
Magno Zito
and Daniel J. Safer
46.
Pharmacoepidemiology of Hormone Therapy: An Evolving Picture
.571
Annlouise
R.
Assaf, Laura E. Burleson and
Joann
E.
Manson
47.
NSAIDs
-
COX-2 Inhibitors
-
Risks and Benefits
.583
K. Arnold Chan and S. Christopher Jones
48.
Introduction to Pharmionics: The Vagaries in Ambulatory Patients' Adherence
to Prescribed Drug Dosing Regimens, and Some of Their
Clinical and Economic Consequences
.603
John Urquhart and Bernard Vrijens
PART V. LESSONS AND DIRECTIONS
. 619
49.
Teaching and Learning Pharmacovigilance
. 621
Frank May
49b. Practical Experience in Teaching Pharmacovigilance
.633
Stephen Evans
viii CONTENTS
50.
Fatal
Medication Errors and Adverse Drug Reactions
-
Coroners' Inquests
and Other Sources
. 635
R.E. Femer, S.E.
McDowell and
Α.Κ.
Cotter
51.
Pharmacogenetics and the Genetic Basis of ADRs
.647
Penelope K. Manasco
52.
Keynote Clinical Lessons from Pharmacovigilance
.667
David H. Law son and Keith Beard
Index
.677 |
| any_adam_object | 1 |
| any_adam_object_boolean | 1 |
| building | Verbundindex |
| bvnumber | BV022420866 |
| ctrlnum | (OCoLC)174100031 (DE-599)BVBBV022420866 |
| dewey-full | 363.19463 |
| dewey-hundreds | 300 - Social sciences |
| dewey-ones | 363 - Other social problems and services |
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| dewey-search | 363.194 63 |
| dewey-sort | 3363.194 263 |
| dewey-tens | 360 - Social problems and services; associations |
| discipline | Soziologie |
| discipline_str_mv | Soziologie |
| edition | 2. ed. |
| format | Book |
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| index_date | 2024-07-02T17:25:39Z |
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| oclc_num | 174100031 |
| open_access_boolean | |
| owner | DE-19 DE-BY-UBM DE-384 |
| owner_facet | DE-19 DE-BY-UBM DE-384 |
| physical | XVIII, 686 S. Ill., graph. Darst. |
| publishDate | 2007 |
| publishDateSearch | 2007 |
| publishDateSort | 2007 |
| publisher | Wiley |
| record_format | marc |
| spelling | Pharmacovigilance ed. Ronald D. Mann ... 2. ed. Chichester [u.a.] Wiley 2007 XVIII, 686 S. Ill., graph. Darst. txt rdacontent n rdamedia nc rdacarrier Pharmaceutical Preparations adverse effects Pharmacoepidemiology methods Product Surveillance, Postmarketing Drug Toxicity classification Pharmacoépidémiologie Pharmacoépidémiologie ram Arzneimittelprüfung (DE-588)4128030-1 gnd rswk-swf Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf Arzneimittelüberwachung (DE-588)4437717-4 gnd rswk-swf (DE-588)4143413-4 Aufsatzsammlung gnd-content Arzneimittelüberwachung (DE-588)4437717-4 s Arzneimittelsicherheit (DE-588)4143182-0 s 1\p DE-604 Arzneimittelprüfung (DE-588)4128030-1 s 2\p DE-604 Mann, Ronald D. Sonstige oth Digitalisierung UB Augsburg application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015629185&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk 2\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Pharmacovigilance Pharmaceutical Preparations adverse effects Pharmacoepidemiology methods Product Surveillance, Postmarketing Drug Toxicity classification Pharmacoépidémiologie Pharmacoépidémiologie ram Arzneimittelprüfung (DE-588)4128030-1 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd |
| subject_GND | (DE-588)4128030-1 (DE-588)4143182-0 (DE-588)4437717-4 (DE-588)4143413-4 |
| title | Pharmacovigilance |
| title_auth | Pharmacovigilance |
| title_exact_search | Pharmacovigilance |
| title_exact_search_txtP | Pharmacovigilance |
| title_full | Pharmacovigilance ed. Ronald D. Mann ... |
| title_fullStr | Pharmacovigilance ed. Ronald D. Mann ... |
| title_full_unstemmed | Pharmacovigilance ed. Ronald D. Mann ... |
| title_short | Pharmacovigilance |
| title_sort | pharmacovigilance |
| topic | Pharmaceutical Preparations adverse effects Pharmacoepidemiology methods Product Surveillance, Postmarketing Drug Toxicity classification Pharmacoépidémiologie Pharmacoépidémiologie ram Arzneimittelprüfung (DE-588)4128030-1 gnd Arzneimittelsicherheit (DE-588)4143182-0 gnd Arzneimittelüberwachung (DE-588)4437717-4 gnd |
| topic_facet | Pharmaceutical Preparations adverse effects Pharmacoepidemiology methods Product Surveillance, Postmarketing Drug Toxicity classification Pharmacoépidémiologie Arzneimittelprüfung Arzneimittelsicherheit Arzneimittelüberwachung Aufsatzsammlung |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=015629185&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT mannronaldd pharmacovigilance |