Genotoxicity and Carcinogenicity Testing of Pharmaceuticals:
Gespeichert in:
| Format: | Elektronisch E-Book |
|---|---|
| Sprache: | English |
| Veröffentlicht: |
Cham
Springer International Publishing
2015
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| Schlagworte: | |
| Online-Zugang: | TUM01 UBT01 Volltext Inhaltsverzeichnis Abstract |
| Beschreibung: | 1 Online Ressource (X, 206 p. 15 illus., 8 illus. in color) |
| ISBN: | 9783319220840 |
| DOI: | 10.1007/978-3-319-22084-0 |
Internformat
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Datensatz im Suchindex
| _version_ | 1804175707187707904 |
|---|---|
| adam_text | GENOTOXICITY AND CARCINOGENICITY TESTING OF PHARMACEUTICALS
/
: 2015
TABLE OF CONTENTS / INHALTSVERZEICHNIS
INTRODUCTION
HISTORY AND CURRENT REGULATORY REQUIREMENTS
GENOTOXICITY TESTING OF API AND IMPURITIES
NEW EMERGING GENOTOXICITY TESTS
CARCINOGENICITY TESTING OF SMALL MOLECULES
ALTERNATIVES TO THE 2-YEAR RODENT STUDIES
ADDRESSING POSITIVE FINDINGS IN CARCINOGENICITY STUDIES
INVESTIGATING TUMOR SIGNALS IN CLINICAL TRIALS
TUMOR PROMOTERS
CARCINOGENICITY TESTING OF BIOLOGICS
IN SILICO PREDICTIVE TESTS
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
GENOTOXICITY AND CARCINOGENICITY TESTING OF PHARMACEUTICALS
/
: 2015
ABSTRACT / INHALTSTEXT
THIS BOOK PROVIDES AN OVERVIEW OF THE NONCLINICAL TESTING STRATEGIES
THAT ARE USED TO ASSES AND DE-RISK THE GENOTOXICITY AND CARCINOGENICITY
PROPERTIES OF HUMAN PHARMACEUTICALS. IT INCLUDES A REVIEW OF RELEVANT
ICH GUIDELINES, NUMEROUS CASE STUDIES WHERE FOLLOW-UP STUDIES WERE
CONDUCTED TO FURTHER INVESTIGATE POSITIVE FINDINGS, AND PRACTICAL
CONSIDERATIONS FOR THE USE OF ALTERNATIVE AND EMERGING TESTS. WITH
CONTRIBUTIONS FROM RECOGNIZED EXPERTS IN THE PHARMACEUTICAL INDUSTRY AND
HEALTH AUTHORITIES, THIS VOLUME PRESENTS A BALANCED VIEW ON THE
INTERPRETATION AND APPLICATION OF GENOTOXICITY AND CARCINOGENICITY
REGULATORY GUIDANCES. GENOTOXICITY AND CARCINOGENICITY TESTING OF
PHARMACEUTICALS IS A VALUABLE RESOURCE FOR SCIENTISTS, REGULATORS, AND
CONSULTANTS THAT ARE ENGAGED IN THE CONDUCT, REPORTING, AND REVIEW OF
NONCLINICAL STUDIES. THIS BOOK WILL ALSO HELP ACADEMICIANS BETTER
UNDERSTAND AND APPRECIATE THE COMPLEXITY OF THE REGULATIONS AND BREADTH
OF TOXICOLOGY RESEARCH THAT ARE NECESSARY TO SUPPORT THE DEVELOPMENT AND
MARKETING OF NEW DRUGS
DIESES SCHRIFTSTUECK WURDE MASCHINELL ERZEUGT.
|
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| illustrated | Not Illustrated |
| indexdate | 2024-07-10T07:20:34Z |
| institution | BVB |
| isbn | 9783319220840 |
| language | English |
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| spelling | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals Michael J. Graziano, David Jacobson-Kram, ed. Cham Springer International Publishing 2015 1 Online Ressource (X, 206 p. 15 illus., 8 illus. in color) txt rdacontent c rdamedia cr rdacarrier Medicine Cancer research Pharmaceutical technology Biomedicine Cancer Research Pharmaceutical Sciences/Technology Medizin Graziano, Michael J. Sonstige oth Jacobson-Kram, David Sonstige oth Erscheint auch als Druckausgabe 978-3-319-22083-3 https://doi.org/10.1007/978-3-319-22084-0 Verlag Volltext Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028632147&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis Springer Fremddatenuebernahme application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028632147&sequence=000003&line_number=0002&func_code=DB_RECORDS&service_type=MEDIA Abstract |
| spellingShingle | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals Medicine Cancer research Pharmaceutical technology Biomedicine Cancer Research Pharmaceutical Sciences/Technology Medizin |
| title | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals |
| title_auth | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals |
| title_exact_search | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals |
| title_full | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals Michael J. Graziano, David Jacobson-Kram, ed. |
| title_fullStr | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals Michael J. Graziano, David Jacobson-Kram, ed. |
| title_full_unstemmed | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals Michael J. Graziano, David Jacobson-Kram, ed. |
| title_short | Genotoxicity and Carcinogenicity Testing of Pharmaceuticals |
| title_sort | genotoxicity and carcinogenicity testing of pharmaceuticals |
| topic | Medicine Cancer research Pharmaceutical technology Biomedicine Cancer Research Pharmaceutical Sciences/Technology Medizin |
| topic_facet | Medicine Cancer research Pharmaceutical technology Biomedicine Cancer Research Pharmaceutical Sciences/Technology Medizin |
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