Drug safety evaluation:
Saved in:
| Main Author: | |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York, NY
Wiley-Interscience
2002
|
| Subjects: | |
| Online Access: | Table of contents Inhaltsverzeichnis |
| Item Description: | Includes bibliographical references and index |
| Physical Description: | XI, 1007 S. Ill., graph. Darst. 24 cm |
| ISBN: | 0471407275 |
Staff View
MARC
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| 245 | 1 | 0 | |a Drug safety evaluation |c Shayne C. Gad |
| 264 | 1 | |a New York, NY |b Wiley-Interscience |c 2002 | |
| 300 | |a XI, 1007 S. |b Ill., graph. Darst. |c 24 cm | ||
| 336 | |b txt |2 rdacontent | ||
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| 500 | |a Includes bibliographical references and index | ||
| 650 | 4 | |a Médicaments - Essais cliniques | |
| 650 | 7 | |a Médicaments - Tests de toxicité |2 ram | |
| 650 | 4 | |a Médicaments - Toxicologie | |
| 650 | 7 | |a Médicaments - Toxicologie - Évaluation |2 ram | |
| 650 | 2 | |a Évaluation préclinique médicament | |
| 650 | 4 | |a Drug Evaluation |z United States | |
| 650 | 4 | |a Drug Evaluation, Preclinical |z United States | |
| 650 | 4 | |a Drugs |x Testing | |
| 650 | 4 | |a Drugs |x Toxicology | |
| 650 | 4 | |a Product Surveillance, Postmarketing |z United States | |
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Record in the Search Index
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| adam_text | CONTENTS
Preface ix
About the Author xi
Chapter 1 Strategy and Phasing for Drug Safety Evaluation in the
Discovery and Development of Pharmaceuticals 1
Chapter 2 Regulation of Human Pharmaceutical Safety 30
Chapter 3 Information Sources: Building and Maintaining Data
Files 99
Chapter 4 Screens in Safety and Hazard Assessment 112
Chapter 5 Acute Toxicity Testing in Drug Safety Evaluation 130
Chapter 6 Genotoxicity 176
Chapter 7 Subchronic and Chronic Toxicity Studies 237
Chapter 8 Developmental and Reproductive Toxicity Testing 258
Chapter 9 Carcinogenicity Studies 297
Chapter 10 Safety Assessment of Inhalant Drugs 335
Chapter 11 Irritation and Local Tissue Tolerance in Pharmaceutical
Safety Assessment 367
vii
viii CONTENTS
Chapter 12 Special Concerns for the Preclinical Evaluation of
Biotechnology Products 404
Chapter 13 Formulations, Routes, and Dosage Designs 442
Chapter 14 Occupational Toxicology in the Pharmaceutical Industry 505
Chapter 15 Immunotoxicology in Pharmaceutical Development 527
Chapter 16 Large Animal Studies 595
Chapter 17 The Applicatioin of In Vitro Techniques in Drug Safety
Assessment 634
Chapter 18 Pharmacokinetics and Toxicokinetics in Drug Safety
Evaluation 691
Chapter 19 Safety Pharmacology 737
Chapter 20 Evaluation of Human Tolerance and Safety in
Clinical Trials: Phase I and Beyond 764
Chapter 21 Postmarketing Safety Evaluation: Monitoring,
Assessing, and Reporting of Adverse Drug Responses
(ADRs) 831
Chapter 22 Statistics in Pharmaceutical Safety Assessment 862
Appendix A Selected Regulatory and Toxicological Acronyms 971
Appendix B Definition of Terms and Lexicon of Clinical
Observations in Nonclinical (Animal) Studies 975
Appendix C Notable Regulatory Internet Addresses 979
Appendix D Glossary of Terms Used in the Clinical Evaluation
of Therapeutic Agents 990
Index 997
|
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| dewey-ones | 615 - Pharmacology and therapeutics |
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| dewey-sort | 3615 219 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| format | Book |
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| geographic | USA |
| geographic_facet | USA |
| id | DE-604.BV014496203 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T19:03:07Z |
| institution | BVB |
| isbn | 0471407275 |
| language | English |
| lccn | 2001046953 |
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| physical | XI, 1007 S. Ill., graph. Darst. 24 cm |
| publishDate | 2002 |
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| publishDateSort | 2002 |
| publisher | Wiley-Interscience |
| record_format | marc |
| spelling | Gad, Shayne C. 1948- Verfasser (DE-588)13238440X aut Drug safety evaluation Shayne C. Gad New York, NY Wiley-Interscience 2002 XI, 1007 S. Ill., graph. Darst. 24 cm txt rdacontent n rdamedia nc rdacarrier Includes bibliographical references and index Médicaments - Essais cliniques Médicaments - Tests de toxicité ram Médicaments - Toxicologie Médicaments - Toxicologie - Évaluation ram Évaluation préclinique médicament Drug Evaluation United States Drug Evaluation, Preclinical United States Drugs Testing Drugs Toxicology Product Surveillance, Postmarketing United States Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf USA Arzneimittelsicherheit (DE-588)4143182-0 s DE-604 http://www.loc.gov/catdir/toc/wiley021/2001046953.html Table of contents HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009883005&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Gad, Shayne C. 1948- Drug safety evaluation Médicaments - Essais cliniques Médicaments - Tests de toxicité ram Médicaments - Toxicologie Médicaments - Toxicologie - Évaluation ram Évaluation préclinique médicament Drug Evaluation United States Drug Evaluation, Preclinical United States Drugs Testing Drugs Toxicology Product Surveillance, Postmarketing United States Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| subject_GND | (DE-588)4143182-0 |
| title | Drug safety evaluation |
| title_auth | Drug safety evaluation |
| title_exact_search | Drug safety evaluation |
| title_full | Drug safety evaluation Shayne C. Gad |
| title_fullStr | Drug safety evaluation Shayne C. Gad |
| title_full_unstemmed | Drug safety evaluation Shayne C. Gad |
| title_short | Drug safety evaluation |
| title_sort | drug safety evaluation |
| topic | Médicaments - Essais cliniques Médicaments - Tests de toxicité ram Médicaments - Toxicologie Médicaments - Toxicologie - Évaluation ram Évaluation préclinique médicament Drug Evaluation United States Drug Evaluation, Preclinical United States Drugs Testing Drugs Toxicology Product Surveillance, Postmarketing United States Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| topic_facet | Médicaments - Essais cliniques Médicaments - Tests de toxicité Médicaments - Toxicologie Médicaments - Toxicologie - Évaluation Évaluation préclinique médicament Drug Evaluation United States Drug Evaluation, Preclinical United States Drugs Testing Drugs Toxicology Product Surveillance, Postmarketing United States Arzneimittelsicherheit USA |
| url | http://www.loc.gov/catdir/toc/wiley021/2001046953.html http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=009883005&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
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