Verfügbarkeit: Targeted regulatory writing techniques

Targeted regulatory writing techniques: clinical documents for drugs and biologics

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Bibliographische Detailangaben
Weitere beteiligte Personen:	Wood, Linda Fossati (HerausgeberIn), Foote, MaryAnn (HerausgeberIn)
Format:	Buch
Sprache:	Englisch
Veröffentlicht:	Basel ; Boston ; Berlin Birkhäuser [2009]
Schlagwörter:	Arzneimittelprüfung Protokoll
Links:	http://d-nb.info/988331640/04 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028398711&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
Beschreibung:	Literaturangaben
Umfang:	X, 237 Seiten Diagramme 24 cm
ISBN:	9783764383619

Internformat

MARC


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Datensatz im Suchindex

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adam_text	CONTENTS LIST OF CONTRIBUTORS VII LIST OF REVIEWERS VIII FOREWORD IX REGULATORY WRITING FUNDAMENTALS CHAPTER 1. DEVELOPING A TARGET 3 LINDA FOSSATI WOOD GETTING STARTED CHAPTER 2. REGULATORY WRITING TIPS 27 LINDA FOSSATI WOOD CHAPTER 3. TEMPLATES AND STYLE GUIDES: THE NUTS AND BOLTS OF REGULATORY DOCUMENTS 33 JAMES YUEN AND DEBRA L ROOD CHAPTER 4. DOCUMENT REVIEW 45 LINDA FOSSATI WOOD AND MARY ANN FOOTE SOURCE DOCUMENTS CHAPTER 5. PROTOCOLS 53 LINDA FOSSATI WOOD CHAPTER 6. CLINICAL STUDY REPORTS 69 LINDA FOSSATI WOOD INTEGRATED DOCUMENTS CHAPTER 7. INVESTIGATOR S BROCHURES 105 LINDA FOSSATI WOOD CHAPTER 8. INVESTIGATIONAL MEDICINAL PRODUCTS DOSSIER 121 LINDA FOSSATI WOOD BIBLIOGRAFISCHE INFORMATIONEN HTTP://D-NB.INFO/988331640 DIGITALISIERT DURCH CONTENTS CHAPTER 9. INTEGRATED SUMMARIES OF SAFETY AND EFFICACY 125 JENNIFER A FISSEKIS CHAPTER 10. INFORMED CONSENT FORMS 131 JENNIFER A FISSEKIS REGULATORY SUBMISSIONS CHAPTER 11. GLOBAL SUBMISSIONS: THE COMMON TECHNICAL DOCUMENT 141 PEGGY BOE CHAPTER 12. CLINICAL TRIAL PROCEDURES AND APPROVAL PROCESSES IN JAPAN 155 TAKUMI ISHIDA AND KATSUNORI KURUSU CHAPTER 13. REGION-SPECIFIC SUBMISSIONS: UNITED STATES OF AMERICA 173 LINDA FOSSATI WOOD APPENDICES I REGULATORY REVIEW CHECKLISTS 189 II SAMPLE CLINICAL PROTOCOL OUTLINE 193 III SAMPLE CLINICAL PROTOCOL TITLE PAGE 195 IV SAMPLE CLINICAL PROTOCOL SIGNATURE PAGE 196 V SAMPLE CLINICAL PROTOCOL SYNOPSIS 197 VI SAMPLE LIST OF ABBREVIATIONS 198 VII SAMPLE PROTOCOL AMENDMENT 199 VIII SAMPLE CLINICAL STUDY REPORT TITLE PAGE 202 IX SAMPLE CLINICAL STUDY REPORT SYNOPSIS 203 X CLINICAL STUDY REPORT OUTLINE: ICH E3 AND SUGGESTED VERSIONS 208 XI SAMPLE INVESTIGATOR S BROCHURE OUTLINE 213 XII INVESTIGATIONAL MEDICINAL PRODUCTS DOSSIER PREVIOUS HUMAN EXPERIENCE OUTLINE 214 XIII SAMPLE INFORMED CONSENT FORM 216 XIV JAPANESE REGULATORY FORMS 218 GLOSSARY AND ABBREVIATIONS 223 INDEX 235
any_adam_object	1
author2	Wood, Linda Fossati Foote, MaryAnn
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dewey-ones	808 - Rhetoric & collections of literature
dewey-raw	808.066615
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dewey-sort	3808.066615
dewey-tens	800 - Literature (Belles-lettres) and rhetoric
discipline	Literaturwissenschaft Medizin
format	Book
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id	DE-604.BV042972934
illustrated	Not Illustrated
indexdate	2024-12-20T17:24:44Z
institution	BVB
isbn	9783764383619
language	English
oai_aleph_id	oai:aleph.bib-bvb.de:BVB01-028398711
oclc_num	316566521
open_access_boolean
owner	DE-355 DE-BY-UBR
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physical	X, 237 Seiten Diagramme 24 cm
publishDate	2009
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publisher	Birkhäuser
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spellingShingle	Targeted regulatory writing techniques clinical documents for drugs and biologics Arzneimittelprüfung (DE-588)4128030-1 gnd Protokoll (DE-588)4047552-9 gnd
subject_GND	(DE-588)4128030-1 (DE-588)4047552-9
title	Targeted regulatory writing techniques clinical documents for drugs and biologics
title_auth	Targeted regulatory writing techniques clinical documents for drugs and biologics
title_exact_search	Targeted regulatory writing techniques clinical documents for drugs and biologics
title_full	Targeted regulatory writing techniques clinical documents for drugs and biologics edited by Linda Fossati Wood and MaryAnn Foote
title_fullStr	Targeted regulatory writing techniques clinical documents for drugs and biologics edited by Linda Fossati Wood and MaryAnn Foote
title_full_unstemmed	Targeted regulatory writing techniques clinical documents for drugs and biologics edited by Linda Fossati Wood and MaryAnn Foote
title_short	Targeted regulatory writing techniques
title_sort	targeted regulatory writing techniques clinical documents for drugs and biologics
title_sub	clinical documents for drugs and biologics
topic	Arzneimittelprüfung (DE-588)4128030-1 gnd Protokoll (DE-588)4047552-9 gnd
topic_facet	Arzneimittelprüfung Protokoll
url	http://d-nb.info/988331640/04 http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=028398711&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA
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