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Table Of Contents

Biotechnology in Pharmaceutical Research
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
Project Team Approval and Refinement of the Plan
Allocation of Resources and Budget Planning
Implementing a Project Plan
Project Management Computer Software
Commercial Chances and Risks of Pharmaceutical Development
Planning and Managing Product Development
Risk Oriented Planning
Decision Making
Organizational Structures
Technical Aspects of Product Development 53
Technical Aspects of Product Development
Process Development and Manufacturing
Patents for Biomedicinal Products
The Purpose of a Patent
Alternatives to Patents
Basic Requirements for a Patentable Invention 65
Basic Requirements for a Patentable Invention
Utility or Industrial Applicability
Bioequivalence and Bioavailability
Additional Preclinical Studies for Veterinary Products
Annex A
Outline of Major Registration Requirements
Annex B
General Information Sources
Pharmacopoeias and Related Books
Information Sources on Excipients
EEC Registration Guidelines for Human Medicinal Products
Information Sources on Registration Requirements in the USA
Information Sources on Registration Requirements in Japan
Registration Guidelines for Veterinary Medicinal Products
References and Further Reading
Index
P. 1
Research and Development of Vaccines and Pharmaceuticals from Biotechnology

Research and Development of Vaccines and Pharmaceuticals from Biotechnology

Ratings: (0)|Views: 31|Likes:
Published by Wiley
Unique in approach, exhaustive in coverage: this book provides information usually not available to scientists.

It 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 practice-oriented, it helps users select and manage successfully the most attractive research and development projects.

An impressive number of topics is covered, including:

* planning and managing product development
* product development phases
* requirements for a patentable invention
* patent costs
* user safety
* ecotoxicity

The book will rapidly pay for itself by more successful fund applications,increased protection and remuneration of intellectual property, and by faster and more efficient product development.
Unique in approach, exhaustive in coverage: this book provides information usually not available to scientists.

It 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 practice-oriented, it helps users select and manage successfully the most attractive research and development projects.

An impressive number of topics is covered, including:

* planning and managing product development
* product development phases
* requirements for a patentable invention
* patent costs
* user safety
* ecotoxicity

The book will rapidly pay for itself by more successful fund applications,increased protection and remuneration of intellectual property, and by faster and more efficient product development.

More info:

Publish date: Jul 11, 2008
Added to Scribd: Jun 29, 2013
Copyright:Traditional Copyright: All rights reservedISBN:9783527615827
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02/17/2015

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9783527615827

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