Drug safety evaluation:
"Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Hoboken, New Jersey
John Wiley & Sons, Inc.
[2017]
|
| Ausgabe: | Third edition |
| Schlagworte: | |
| Online-Zugang: | FRO01 UBG01 Volltext Inhaltsverzeichnis |
| Zusammenfassung: | "Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher |
| Beschreibung: | THE DRUG DEVELOPMENT PROCESS AND THE GLOBAL PHARMACEUTICAL MARKETPLACE -- REGULATION OF HUMAN PHARMACEUTICAL SAFETY -- DATA MINING -- SCREENS IN SAFETY AND HAZARD ASSESSMENT -- FORMULATIONS, ROUTES, AND DOSAGE REGIMENS -- NONCLINICAL MANIFESTATIONS, MECHANISMS, AND END POINTS OF DRUG TOXICITY -- PILOT TOXICITY TESTING IN DRUG SAFETY EVALUATION -- REPEAT-DOSE TOXICITY STUDIES -- GENOTOXICITY -- QSAR TOOLS FOR DRUG SAFETY -- IMMUNOTOXICOLOGY IN DRUG DEVELOPMENT -- NONRODENT ANIMAL STUDIES -- DEVELOPMENTAL AND REPRODUCTIVE TOXICITY TESTING -- CARCINOGENICITY STUDIES -- HISTOPATHOLOGY IN NONCLINICAL PHARMACEUTICAL SAFETY ASSESSMENT -- IRRITATION AND LOCAL TISSUE TOLERANCE IN PHARMACEUTICAL SAFETY ASSESSMENT -- PHARMACOKINETICS AND TOXICOKINETICS IN DRUG SAFETY EVALUATION -- SAFETY PHARMACOLOGY -- SPECIAL CONCERNS FOR THE PRECLINICAL EVALUATION OF BIOTECHNOLOGY PRODUCTS -- SAFETY ASSESSMENT OF INHALANT DRUGS AND DERMAL ROUTE DRUGS -- SPECIAL CASE PRODUCTS -- SPECIAL CASE PRODUCTS -- - PEDIATRIC PRODUCT SAFETY ASSESSMENT (2006 GUIDANCE, INCLUDING JUVENILE TOXICOLOGY) -- USE OF IMAGING, IMAGING AGENTS, AND RADIOPHARMACEUTICALS IN NONCLINICAL TOXICOLOGY -- OCCUPATIONAL TOXICOLOGY IN THE PHARMACEUTICAL INDUSTRY -- STRATEGY AND PHASING FOR NONCLINICAL DRUG SAFETY EVALUATION IN THE DISCOVERY AND DEVELOPMENT OF PHARMACEUTICALS -- THE APPLICATION OF IN VITRO TECHNIQUES IN DRUG SAFETY ASSESSMENT -- EVALUATION OF HUMAN TOLERANCE AND SAFETY IN CLINICAL TRIALS -- POSTMARKETING SAFETY EVALUATION -- STATISTICS IN PHARMACEUTICAL SAFETY ASSESSMENT -- COMBINATION PRODUCTS -- QUALIFICATION OF IMPURITIES, DEGRADANTS, RESIDUAL SOLVENTS, METALS, AND LEACHABLES IN PHARMACEUTICALS -- TISSUE, CELL, AND GENE THERAPY -- APPENDIX A: SELECTED REGULATORY AND TOXICOLOGICAL ACRONYMS -- APPENDIX B: DEFINITION OF TERMS AND LEXICON OF "CLINICAL" OBSERVATIONS IN NONCLINICAL (ANIMAL) STUDIES -- APPENDIX C: NOTABLE REGULATORY INTERNET ADDRESSES -- - APPENDIX D: GLOSSARY OF TERMS USED IN THE CLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX E: COMMON VEHICLES FOR THE NONCLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX F: GLOBAL DIRECTORY OF CONTRACT PHARMACEUTICAL TOXICOLOGY LABS -- INDEX. - Includes bibliographical references and index |
| Beschreibung: | 1 online resource (pages) |
| ISBN: | 1119097401 1119097444 9781119097402 9781119097440 |
Internformat
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| 500 | |a - APPENDIX D: GLOSSARY OF TERMS USED IN THE CLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX E: COMMON VEHICLES FOR THE NONCLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX F: GLOBAL DIRECTORY OF CONTRACT PHARMACEUTICAL TOXICOLOGY LABS -- INDEX. - Includes bibliographical references and index | ||
| 520 | |a "Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher | ||
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Datensatz im Suchindex
| _version_ | 1804177004569821184 |
|---|---|
| adam_text | INHALT
VORWORT.....................................................................
9
1. TIGER:
MEISTER DES STERNENTORS
....................................12
2. ELEFANTEN:
GUTE SCHWINGUNGEN
..................................68
3. LOEWEN:
KOENIGE UND KOENIGINNEN
................................
117
4. HERRLICHE WEISSE HAIE:
SPASS MIT MESSERSCHARFEN ZAEHNEN
.................................168
5. DIE SCHWARZE MAMBA:
DER TANZ M IT DEM T OD
......
198
6. BIENEN:
KINDER DER SON NE
.....................................
236
7. WALE:
D ER BEIRAT DER W EISEN
..................................281
DANKSAGUNGEN
.......................................................
337
RESSOURCEN
............................................................
338
LITERATURVERZEICHNIS
...............................................
339
UEBER DIE AUTORIN
....................................................
341
|
| any_adam_object | 1 |
| author | Gad, Shayne C. 1948- |
| author_GND | (DE-588)13238440X |
| author_facet | Gad, Shayne C. 1948- |
| author_role | aut |
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| dewey-full | 615/.19 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.19 |
| dewey-search | 615/.19 |
| dewey-sort | 3615 219 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| edition | Third edition |
| format | Electronic eBook |
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| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:41:11Z |
| institution | BVB |
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| language | English |
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| publisher | John Wiley & Sons, Inc. |
| record_format | marc |
| spelling | Gad, Shayne C. 1948- (DE-588)13238440X aut Drug safety evaluation Shayne Cox Gad Third edition Hoboken, New Jersey John Wiley & Sons, Inc. [2017] 1 online resource (pages) txt rdacontent c rdamedia cr rdacarrier THE DRUG DEVELOPMENT PROCESS AND THE GLOBAL PHARMACEUTICAL MARKETPLACE -- REGULATION OF HUMAN PHARMACEUTICAL SAFETY -- DATA MINING -- SCREENS IN SAFETY AND HAZARD ASSESSMENT -- FORMULATIONS, ROUTES, AND DOSAGE REGIMENS -- NONCLINICAL MANIFESTATIONS, MECHANISMS, AND END POINTS OF DRUG TOXICITY -- PILOT TOXICITY TESTING IN DRUG SAFETY EVALUATION -- REPEAT-DOSE TOXICITY STUDIES -- GENOTOXICITY -- QSAR TOOLS FOR DRUG SAFETY -- IMMUNOTOXICOLOGY IN DRUG DEVELOPMENT -- NONRODENT ANIMAL STUDIES -- DEVELOPMENTAL AND REPRODUCTIVE TOXICITY TESTING -- CARCINOGENICITY STUDIES -- HISTOPATHOLOGY IN NONCLINICAL PHARMACEUTICAL SAFETY ASSESSMENT -- IRRITATION AND LOCAL TISSUE TOLERANCE IN PHARMACEUTICAL SAFETY ASSESSMENT -- PHARMACOKINETICS AND TOXICOKINETICS IN DRUG SAFETY EVALUATION -- SAFETY PHARMACOLOGY -- SPECIAL CONCERNS FOR THE PRECLINICAL EVALUATION OF BIOTECHNOLOGY PRODUCTS -- SAFETY ASSESSMENT OF INHALANT DRUGS AND DERMAL ROUTE DRUGS -- SPECIAL CASE PRODUCTS -- SPECIAL CASE PRODUCTS -- - PEDIATRIC PRODUCT SAFETY ASSESSMENT (2006 GUIDANCE, INCLUDING JUVENILE TOXICOLOGY) -- USE OF IMAGING, IMAGING AGENTS, AND RADIOPHARMACEUTICALS IN NONCLINICAL TOXICOLOGY -- OCCUPATIONAL TOXICOLOGY IN THE PHARMACEUTICAL INDUSTRY -- STRATEGY AND PHASING FOR NONCLINICAL DRUG SAFETY EVALUATION IN THE DISCOVERY AND DEVELOPMENT OF PHARMACEUTICALS -- THE APPLICATION OF IN VITRO TECHNIQUES IN DRUG SAFETY ASSESSMENT -- EVALUATION OF HUMAN TOLERANCE AND SAFETY IN CLINICAL TRIALS -- POSTMARKETING SAFETY EVALUATION -- STATISTICS IN PHARMACEUTICAL SAFETY ASSESSMENT -- COMBINATION PRODUCTS -- QUALIFICATION OF IMPURITIES, DEGRADANTS, RESIDUAL SOLVENTS, METALS, AND LEACHABLES IN PHARMACEUTICALS -- TISSUE, CELL, AND GENE THERAPY -- APPENDIX A: SELECTED REGULATORY AND TOXICOLOGICAL ACRONYMS -- APPENDIX B: DEFINITION OF TERMS AND LEXICON OF "CLINICAL" OBSERVATIONS IN NONCLINICAL (ANIMAL) STUDIES -- APPENDIX C: NOTABLE REGULATORY INTERNET ADDRESSES -- - APPENDIX D: GLOSSARY OF TERMS USED IN THE CLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX E: COMMON VEHICLES FOR THE NONCLINICAL EVALUATION OF THERAPEUTIC AGENTS -- APPENDIX F: GLOBAL DIRECTORY OF CONTRACT PHARMACEUTICAL TOXICOLOGY LABS -- INDEX. - Includes bibliographical references and index "Provides practical guidance to solve scientific and regulatory issues in preclinical safety assessment, early clinical drug development, and post-approval impurity issues"--Provided by publisher MEDICAL / Pharmacology bisacsh Drugs / Testing fast Drugs / Toxicology fast Medizin Drugs / Toxicology Drugs / Testing Arzneimittelsicherheit (DE-588)4143182-0 gnd rswk-swf Arzneimittelsicherheit (DE-588)4143182-0 s 1\p DE-604 Erscheint auch als Druckausgabe 978-1-119-09739-6 https://onlinelibrary.wiley.com/doi/book/10.1002/9781119097440 Verlag URL des Erstveröffentlichers Volltext DNB Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029420950&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis 1\p cgwrk 20201028 DE-101 https://d-nb.info/provenance/plan#cgwrk |
| spellingShingle | Gad, Shayne C. 1948- Drug safety evaluation MEDICAL / Pharmacology bisacsh Drugs / Testing fast Drugs / Toxicology fast Medizin Drugs / Toxicology Drugs / Testing 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 Cox Gad |
| title_fullStr | Drug safety evaluation Shayne Cox Gad |
| title_full_unstemmed | Drug safety evaluation Shayne Cox Gad |
| title_short | Drug safety evaluation |
| title_sort | drug safety evaluation |
| topic | MEDICAL / Pharmacology bisacsh Drugs / Testing fast Drugs / Toxicology fast Medizin Drugs / Toxicology Drugs / Testing Arzneimittelsicherheit (DE-588)4143182-0 gnd |
| topic_facet | MEDICAL / Pharmacology Drugs / Testing Drugs / Toxicology Medizin Arzneimittelsicherheit |
| url | https://onlinelibrary.wiley.com/doi/book/10.1002/9781119097440 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=029420950&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| work_keys_str_mv | AT gadshaynec drugsafetyevaluation |