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Research and development of vaccines and pharmaceuticals from biotechnology : a guide to effective project management, patenting, and product registration

Author: Jens-Peter Gregersen; Wiley InterScience (Online service)
Publisher: Weinheim ; New York : VCH, ©1994.
Edition/Format:   eBook : Document : EnglishView all editions and formats
Database:WorldCat
Summary:

Explains the basic scientific and technical requirements which apply to the patenting and registration of human or veterinary vaccines and therapeutic biomedicinal products. Pragmatic and  Read more...

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Genre/Form: Electronic books
Patents
Additional Physical Format: (OCoLC)31599958
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: Jens-Peter Gregersen; Wiley InterScience (Online service)
ISBN: 9783527615834 3527615830
OCLC Number: 212133788
Reproduction Notes: Electronic reproduction. Hoboken, N.J. : Wiley InterScience, 2008. Mode of access: World Wide Web. System requirements: Web browser. Title from title screen (viewed on Feb. 18, 2008). Access may be restricted to users at subscribing institutions.
Description: xi, 173 pages : illustrations
Contents: From the Contents: Preface Biotechnology in Pharmaceutical Research A Scientific Leap Forward Biotechnology in the 1990's Research Structures Basic or Applied Research or Where do you want to get to? The Aim of a Project Defining the Aim Creative Market Research and Other Valuable Background Information Project Planning The Backwards Approach to establish a Plan Linking Project Tasks Objectives and Milestones Time and Task Dependencies Project Team Approval and Refinement of the Plan Allocation of Resources and Budget Planning Changes to the Plan Implementing a Project Plan Project Management Computer Software Product Development Product Development Follows Different Rules Commercial Chances and Risks of Pharmaceutical Development Product Profile and Market Assessment of Development Products - Planning and Managing Product Development - Technical Aspects of Product Development Patents for Biomedical Products The Purpose of the Patent Alternatives to Patents - Basic Requirements for a Patentable Invention - The Patent Application - Selling an Invention, Licences and Royalties Registration Requirements - Three Basic Elements - Registration Applications and Procedures - Requirements for the Preclinical Pharmacology and Safety Assessment - Additional Preclinical Studies for Veterinary Products - Annex A: Outline of Major Registration Requirements - Annex B: References and Information Sources on Regulatory Matters References Index
Responsibility: Jens-Peter Gregersen.

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