Safety pharmacology in pharmaceutical development: approval and post marketing surveillance
Gespeichert in:
1. Verfasser: | |
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Format: | Elektronisch E-Book |
Sprache: | English |
Veröffentlicht: |
Hoboken
CRC Press
2012
|
Ausgabe: | 2. ed. |
Schlagworte: | |
Online-Zugang: | TUM01 Volltext |
Beschreibung: | Description based upon print version of record This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international--especially Europe and Japan) and updated test methods, interpretation, and science Front Cover; Contents; Preface; About the Author; Chapter 1: Safety pharmacology: Background, history, issues, and concerns; Chapter 2: Regulatory requirements: ICH, FDA, EMA, and Japan; Chapter 3: Principles of screening and study design; Chapter 4: Cardiovascular system; Chapter 5: Central nervous system; Chapter 6: Respiratory system; Chapter 7: Renal function; Chapter 8: The gastrointestinal system; Chapter 9: The immune system; Appendix A: Acronyms; Appendix B: Laboratories conducting safety pharmacology testing; Back Cover |
Beschreibung: | 1 Online-Ressource (xv, 180 p.) |
ISBN: | 1439845689 9781439845684 |
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500 | |a Description based upon print version of record | ||
500 | |a This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international--especially Europe and Japan) and updated test methods, interpretation, and science | ||
500 | |a Front Cover; Contents; Preface; About the Author; Chapter 1: Safety pharmacology: Background, history, issues, and concerns; Chapter 2: Regulatory requirements: ICH, FDA, EMA, and Japan; Chapter 3: Principles of screening and study design; Chapter 4: Cardiovascular system; Chapter 5: Central nervous system; Chapter 6: Respiratory system; Chapter 7: Renal function; Chapter 8: The gastrointestinal system; Chapter 9: The immune system; Appendix A: Acronyms; Appendix B: Laboratories conducting safety pharmacology testing; Back Cover | ||
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Datensatz im Suchindex
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any_adam_object | |
author | Gad, Shayne C. 1948- |
author_GND | (DE-588)13238440X |
author_facet | Gad, Shayne C. 1948- |
author_role | aut |
author_sort | Gad, Shayne C. 1948- |
author_variant | s c g sc scg |
building | Verbundindex |
bvnumber | BV040474386 |
collection | ZDB-4-NLEBK |
ctrlnum | (OCoLC)874195421 (DE-599)BVBBV040474386 |
edition | 2. ed. |
format | Electronic eBook |
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id | DE-604.BV040474386 |
illustrated | Not Illustrated |
indexdate | 2024-07-10T00:24:36Z |
institution | BVB |
isbn | 1439845689 9781439845684 |
language | English |
oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-025321674 |
oclc_num | 874195421 |
open_access_boolean | |
owner | DE-91 DE-BY-TUM |
owner_facet | DE-91 DE-BY-TUM |
physical | 1 Online-Ressource (xv, 180 p.) |
psigel | ZDB-4-NLEBK ZDB-4-NLEBK TUM_PDA_EBSCO_MED_gekauft |
publishDate | 2012 |
publishDateSearch | 2012 |
publishDateSort | 2012 |
publisher | CRC Press |
record_format | marc |
spelling | Gad, Shayne C. 1948- Verfasser (DE-588)13238440X aut Safety pharmacology in pharmaceutical development approval and post marketing surveillance 2. ed. Hoboken CRC Press 2012 1 Online-Ressource (xv, 180 p.) txt rdacontent c rdamedia cr rdacarrier Description based upon print version of record This book covers the regulatory required evaluation and study of the potentially adverse pharmacological effects of new drugs. Coverage ranges from the general regulatory requirements to the specific studies that must be done and how they are performed and interpreted. Based on more than 30 years of direct experience, the author describes tricks and practical insights for making studies work and understanding why they don't. The second edition includes current regulations (US FDA and international--especially Europe and Japan) and updated test methods, interpretation, and science Front Cover; Contents; Preface; About the Author; Chapter 1: Safety pharmacology: Background, history, issues, and concerns; Chapter 2: Regulatory requirements: ICH, FDA, EMA, and Japan; Chapter 3: Principles of screening and study design; Chapter 4: Cardiovascular system; Chapter 5: Central nervous system; Chapter 6: Respiratory system; Chapter 7: Renal function; Chapter 8: The gastrointestinal system; Chapter 9: The immune system; Appendix A: Acronyms; Appendix B: Laboratories conducting safety pharmacology testing; Back Cover MEDICAL / Pharmacology bisacsh Medizin Drug Approval Drug Evaluation, Preclinical Drugs -- Safety measures Drugs -- Toxicology Toxicity Tests Drug development / Safety measures MEDICAL / Pharmacology / bisacsh Erscheint auch als Druck-Ausgabe, Hardcover 978-1-4398-4567-7 http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=452071 Verlag Volltext |
spellingShingle | Gad, Shayne C. 1948- Safety pharmacology in pharmaceutical development approval and post marketing surveillance MEDICAL / Pharmacology bisacsh Medizin Drug Approval Drug Evaluation, Preclinical Drugs -- Safety measures Drugs -- Toxicology Toxicity Tests Drug development / Safety measures MEDICAL / Pharmacology / bisacsh |
title | Safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_auth | Safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_exact_search | Safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_full | Safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_fullStr | Safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_full_unstemmed | Safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_short | Safety pharmacology in pharmaceutical development |
title_sort | safety pharmacology in pharmaceutical development approval and post marketing surveillance |
title_sub | approval and post marketing surveillance |
topic | MEDICAL / Pharmacology bisacsh Medizin Drug Approval Drug Evaluation, Preclinical Drugs -- Safety measures Drugs -- Toxicology Toxicity Tests Drug development / Safety measures MEDICAL / Pharmacology / bisacsh |
topic_facet | MEDICAL / Pharmacology Medizin Drug Approval Drug Evaluation, Preclinical Drugs -- Safety measures Drugs -- Toxicology Toxicity Tests Drug development / Safety measures MEDICAL / Pharmacology / bisacsh |
url | http://search.ebscohost.com/login.aspx?direct=true&scope=site&db=nlebk&db=nlabk&AN=452071 |
work_keys_str_mv | AT gadshaynec safetypharmacologyinpharmaceuticaldevelopmentapprovalandpostmarketingsurveillance |