Research and development of vaccines and pharmaceuticals from biotechnology: a guide to effective project management, patenting and product registration
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Weinheim u.a.
VCH
1994
|
| Schlagworte: | |
| Online-Zugang: | Inhaltsverzeichnis |
| Beschreibung: | Literaturverz. S. 161 - 165 |
| Beschreibung: | XI, 173 S. |
| ISBN: | 3527300597 |
Internformat
MARC
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Datensatz im Suchindex
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|---|---|
| adam_text | JENS-PETER GREGERSEN RESEARCH AND DEVELOPMENT OF VACCINES AND
PHARMACEUTICALS FROM BIOTECHNOLOGY A GUIDE TO EFFECTIVE PROJECT
MANAGEMENT, PATENTING AND PRODUCT REGISTRATION WEINHEIM * NEW YORK BASEL
* CAMBRIDGE * TOKYO TABLE OF CONTENTS PREFACE VII BIOTECHNOLOGY IN
PHARMACEUTICAL RESEARCH 1 BIOTECHNOLOGY IN THE 1990 S 2 RESEARCH
STRUCTURES 3 BASIC OR APPLIED RESEARCH OR WHERE DO YOU WANT TO GET TO? 6
THE AIM OF A PROJECT 9 DEFINING THE AIM 9 CREATIVE MARKET RESEARCH AND
OTHER VALUABLE BACKGROUND INFORMATION 10 PROJECT PLANNING 15 THE
BACKWARDS APPROACH TO ESTABLISH A PLAN 16 LINKING PROJECT TASKS 21
OBJECTIVES AND MILESTONES 21 TIME AND TASK DEPENDENCIES 22 PROJECT TEAM
APPROVAL AND REFINEMENT OF THE PLAN 23 ALLOCATION OF RESOURCES AND
BUDGET PLANNING 24 CHANGES TO THE PLAN 26 IMPLEMENTING A PROJECT PLAN 27
PROJECT MANAGEMENT COMPUTER SOFTWARE 28 PRODUCT DEVELOPMENT 31 PRODUCT
DEVELOPMENT FOLLOWS DIFFERENT RULES 31 COMMERCIAL CHANCES AND RISKS OF
PHARMACEUTICAL DEVELOPMENT 32 PRODUCT PROFILE AND MARKET ASSESSMENT OF
DEVELOPMENT PRODUCTS .... 35 PLANNING AND MANAGING PRODUCT DEVELOPMENT 3
K RISK ORIENTED PLANNING 39 PRODUCT DEVELOPMENT PHASES 41 DECISION
MAKING 45 THE PROJECT MANAGER 47 ORGANIZATIONAL STRUCTURES 50 TECHNICAL
ASPECTS OF PRODUCT DEVELOPMENT 53 PROCESS DEVELOPMENT AND MANUFACTURING
53 ANALYTICAL DEVELOPMENT AND QUALITY ASSURANCE 57 PATENTS FOR
BIOMEDICINAL PRODUCTS 61 THE PURPOSE OF A PATENT 62 ALTERNATIVES TO
PATENTS 63 BASIC REQUIREMENTS FOR A PATENTABLE INVENTION 65 NOVELTY 65
NON -OBVIOUSNESS 66 UTILITY OR INDUSTRIAL APPLICABILITY 67 X TABLE OF
CONTENTS INVENTIONS, DISCOVERIES AND PRODUCTS OF NATURE 69 PATENTABLE
INVENTIONS AND EXCLUSIONS 71 PRODUCT, PROCESS AND USE PATENTS 76
DEPENDENT PATENTS 78 THE PATENT APPLICATION 79 THE PATENT DESCRIPTION 79
DEPOSITION OF MICROORGANISMS 80 PATENT CLAIMS 82 FILING A PATENT
APPLICATION 85 PRIORITY OF PATENTS AND CONTINUATION-IN-PART 89 DURATION
OF PATENT PROTECTION 90 EXTENSION OF PATENT TERMS FOR PHARMACEUTICALS 91
OPPOSITIONS AGAINST PATENTS 92 PATENT COSTS 93 PATENT INFORMATION 94
CHECK LIST FOR PROSPECTIVE PATENT APPLICANTS 96 SELLING AN INVENTION,
LICENCES AND ROYALTIES 97 REGISTRATION REQUIREMENTS 101 THREE BASIC
ELEMENTS ^ QUALITY ^ SAFETY 104 EFFICACY J REGISTRATION APPLICATIONS
AND PROCEDURES 1U APPROVAL FOR CLINICAL TRIALS ^J: APPLICATIONS FOR
MARKET APPROVAL }Y REGISTRATION IN THE EEC L V. REGISTRATION IN THE USA
]YL REGISTRATION IN JAPAN : Q REQUIREMENTS FOR THE PRECLINICAL
PHARMACOLOGY AND SAFETY ASSESSMENT * * JL? EXCEPTIONS AND VARIATIONS FOR
BIOLOGICAL PRODUCTS . NEW VACCINE ADJUVANTS AND OTHER EXCIPIENTS ,.
PHARMACOKINETICS ., PHARMACODYNAMICS .,, BIOEQUIVALENCE AND
BIOAVAILABILITY .-A SINGLE DOSETOXICITY (ACUTE TOXICITY) .-5 REPEATED
DOSETOXICITY (SUBACUTE, CHRONIC TOXICITY) ..- REPRODUCTION TOXICITY ^S
MUTAGENICITY .-9 TUMORIGENICITY (CARCINOGENICITY) ,IQ IMMUNOTOXICITY ^
LOCAL TOLERANCE ^2 ADDITIONAL PRECLINICAL STUDIES FOR VETERINARY
PRODUCTS ^2 USER SAFETY 22 TOLERANCE IN THE TARGET SPECIES 132
ECOTOXICITY ^3 SAFETY OF RESIDUES TABLE OF ( (INTENTS X1 ANNEX A OUTLINE
OF MAJOR REGISTRATION REQUIREMENTS 135 MAJOR REGISTRATION REQUIREMENTS
FOR HUMAN MEDICINAL PRODUCTS. TABLES 11-15 135 MAJOR REGISTRATION
REQUIREMENTS FOR VETERINARY MEDICINAL PRODUCTS, TABLES 16-21 141 ANNEX B
REFERENCES AND INFORMATION SOURCES ON REGULATORY MATTERS 149 GENERAL
INFORMATION SOURCES 150 PHARMACOPOEIAS AND RELATED BOOKS 151 INFORMATION
SOURCES ON EXCIPIENTS 151 EEC REGISTRATION GUIDELINES FOR HUMAN
MEDICINAL PRODUCTS 152 INFORMATION SOURCES ON REGISTRATION REQUIREMENTS
IN THE USA 155 INFORMATION SOURCES ON REGISTRATION REQUIREMENTS IN JAPAN
156 REGISTRATION GUIDELINES FOR VETERINARY MEDICINAL PRODUCTS 157
REFERENCES AND FURTHER READING 161 INDEX 167
|
| any_adam_object | 1 |
| author | Gregersen, Jens-Peter |
| author_facet | Gregersen, Jens-Peter |
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| author_sort | Gregersen, Jens-Peter |
| author_variant | j p g jpg |
| building | Verbundindex |
| bvnumber | BV009719005 |
| callnumber-first | R - Medicine |
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| callnumber-subject | RS - Pharmacy |
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| dewey-ones | 338 - Production |
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| dewey-sort | 3338.476606 |
| dewey-tens | 330 - Economics |
| discipline | Wirtschaftswissenschaften |
| format | Book |
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| id | DE-604.BV009719005 |
| illustrated | Not Illustrated |
| indexdate | 2024-07-09T17:39:47Z |
| institution | BVB |
| isbn | 3527300597 |
| language | English |
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| physical | XI, 173 S. |
| publishDate | 1994 |
| publishDateSearch | 1994 |
| publishDateSort | 1994 |
| publisher | VCH |
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| spelling | Gregersen, Jens-Peter Verfasser aut Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration Jens-Peter Gregersen Weinheim u.a. VCH 1994 XI, 173 S. txt rdacontent n rdamedia nc rdacarrier Literaturverz. S. 161 - 165 Vaccines cabt Pharmaceutical Products cabt Biotechnology cabt Recht Biotechnology Patents Biotechnology Research Biotechnology Japan Biotechnology United States Drug Approval Japan Drug Approval United States Drug Industry organization & administration Japan Drug Industry organization & administration United States Drugs Research Pharmaceutical biotechnology Law and legislation Planning Techniques Japan Planning Techniques United States Research organization & administration Japan Research organization & administration United States Technology, Pharmaceutical Japan Technology, Pharmaceutical United States Vaccines Biotechnology Arzneimittel (DE-588)4003115-9 gnd rswk-swf Biotechnologie (DE-588)4069491-4 gnd rswk-swf Impfstoff (DE-588)4026655-2 gnd rswk-swf Herstellung (DE-588)4159653-5 gnd rswk-swf USA Impfstoff (DE-588)4026655-2 s Herstellung (DE-588)4159653-5 s Biotechnologie (DE-588)4069491-4 s DE-604 Arzneimittel (DE-588)4003115-9 s GBV Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=006429614&sequence=000001&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Gregersen, Jens-Peter Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration Vaccines cabt Pharmaceutical Products cabt Biotechnology cabt Recht Biotechnology Patents Biotechnology Research Biotechnology Japan Biotechnology United States Drug Approval Japan Drug Approval United States Drug Industry organization & administration Japan Drug Industry organization & administration United States Drugs Research Pharmaceutical biotechnology Law and legislation Planning Techniques Japan Planning Techniques United States Research organization & administration Japan Research organization & administration United States Technology, Pharmaceutical Japan Technology, Pharmaceutical United States Vaccines Biotechnology Arzneimittel (DE-588)4003115-9 gnd Biotechnologie (DE-588)4069491-4 gnd Impfstoff (DE-588)4026655-2 gnd Herstellung (DE-588)4159653-5 gnd |
| subject_GND | (DE-588)4003115-9 (DE-588)4069491-4 (DE-588)4026655-2 (DE-588)4159653-5 |
| title | Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration |
| title_auth | Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration |
| title_exact_search | Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration |
| title_full | Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration Jens-Peter Gregersen |
| title_fullStr | Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration Jens-Peter Gregersen |
| title_full_unstemmed | Research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management, patenting and product registration Jens-Peter Gregersen |
| title_short | Research and development of vaccines and pharmaceuticals from biotechnology |
| title_sort | research and development of vaccines and pharmaceuticals from biotechnology a guide to effective project management patenting and product registration |
| title_sub | a guide to effective project management, patenting and product registration |
| topic | Vaccines cabt Pharmaceutical Products cabt Biotechnology cabt Recht Biotechnology Patents Biotechnology Research Biotechnology Japan Biotechnology United States Drug Approval Japan Drug Approval United States Drug Industry organization & administration Japan Drug Industry organization & administration United States Drugs Research Pharmaceutical biotechnology Law and legislation Planning Techniques Japan Planning Techniques United States Research organization & administration Japan Research organization & administration United States Technology, Pharmaceutical Japan Technology, Pharmaceutical United States Vaccines Biotechnology Arzneimittel (DE-588)4003115-9 gnd Biotechnologie (DE-588)4069491-4 gnd Impfstoff (DE-588)4026655-2 gnd Herstellung (DE-588)4159653-5 gnd |
| topic_facet | Vaccines Pharmaceutical Products Biotechnology Recht Biotechnology Patents Biotechnology Research Biotechnology Japan Biotechnology United States Drug Approval Japan Drug Approval United States Drug Industry organization & administration Japan Drug Industry organization & administration United States Drugs Research Pharmaceutical biotechnology Law and legislation Planning Techniques Japan Planning Techniques United States Research organization & administration Japan Research organization & administration United States Technology, Pharmaceutical Japan Technology, Pharmaceutical United States Vaccines Biotechnology Arzneimittel Biotechnologie Impfstoff Herstellung USA |
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