Safety evaluation of pharmaceuticals and medical devices: international regulatory guidelines
The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice...
Gespeichert in:
| 1. Verfasser: | |
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| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
New York, NY [u.a.]
Springer Science+Business Media, LLC
2011
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| Schlagworte: | |
| Online-Zugang: | UBT01 Volltext |
| Zusammenfassung: | The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries. |
| Beschreibung: | 1 Online-Ressource |
| ISBN: | 9781441974495 |
| DOI: | 10.1007/978-1-4419-7449-5 |
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Datensatz im Suchindex
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| author | Gad, Shayne C. 1948- |
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| discipline | Chemie / Pharmazie |
| doi_str_mv | 10.1007/978-1-4419-7449-5 |
| format | Electronic eBook |
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| illustrated | Not Illustrated |
| indexdate | 2024-07-10T00:12:48Z |
| institution | BVB |
| isbn | 9781441974495 |
| language | English |
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| spelling | Gad, Shayne C. 1948- Verfasser (DE-588)13238440X aut Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines Shayne C. Gad New York, NY [u.a.] Springer Science+Business Media, LLC 2011 1 Online-Ressource txt rdacontent c rdamedia cr rdacarrier The inspiration for this text was the 1988 volume by Alder and Zbinden, written before the ICH harmonization process for drug safety evaluation (or its ISO analog for device biocompatibility evaluation) had been initiated or come to force. Since then, much has changed in both the world and practice of medicine and the regulation of drugs. The intent of this volume is to provide similar guidance as to what nonclinical safety assessment tests need to be performed to move a drug into man, through development and to market approved (this intent was subsequently extended to cover the closely related medical device biotechnology, and combination product fields) in a concise, abbreviated manner for all the major world market countries. Medizin Arzneimittel (DE-588)4003115-9 gnd rswk-swf Pharmazeutische Technologie (DE-588)4045699-7 gnd rswk-swf Sicherheit (DE-588)4054790-5 gnd rswk-swf Toxizität (DE-588)4078372-8 gnd rswk-swf Medicine Toxicology Pharmaceutical technology Pharmacy Arzneimittel (DE-588)4003115-9 s Toxizität (DE-588)4078372-8 s DE-604 Pharmazeutische Technologie (DE-588)4045699-7 s Sicherheit (DE-588)4054790-5 s Erscheint auch als Druckausgabe 978-1-4419-7448-8 https://doi.org/10.1007/978-1-4419-7449-5 Verlag Volltext |
| spellingShingle | Gad, Shayne C. 1948- Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines Medizin Arzneimittel (DE-588)4003115-9 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Sicherheit (DE-588)4054790-5 gnd Toxizität (DE-588)4078372-8 gnd |
| subject_GND | (DE-588)4003115-9 (DE-588)4045699-7 (DE-588)4054790-5 (DE-588)4078372-8 |
| title | Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines |
| title_auth | Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines |
| title_exact_search | Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines |
| title_full | Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines Shayne C. Gad |
| title_fullStr | Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines Shayne C. Gad |
| title_full_unstemmed | Safety evaluation of pharmaceuticals and medical devices international regulatory guidelines Shayne C. Gad |
| title_short | Safety evaluation of pharmaceuticals and medical devices |
| title_sort | safety evaluation of pharmaceuticals and medical devices international regulatory guidelines |
| title_sub | international regulatory guidelines |
| topic | Medizin Arzneimittel (DE-588)4003115-9 gnd Pharmazeutische Technologie (DE-588)4045699-7 gnd Sicherheit (DE-588)4054790-5 gnd Toxizität (DE-588)4078372-8 gnd |
| topic_facet | Medizin Arzneimittel Pharmazeutische Technologie Sicherheit Toxizität |
| url | https://doi.org/10.1007/978-1-4419-7449-5 |
| work_keys_str_mv | AT gadshaynec safetyevaluationofpharmaceuticalsandmedicaldevicesinternationalregulatoryguidelines |