Medical & Biotechnical Industries, Biology - Biotechnology, Biotechnology & Bioengineering
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Overview
Good practices in biotechnology are extensive and far reaching. Some issues are product or process specific, other are more generic. This text brings together a discussion of many of the key issues and regulations thereby providing a valuable resource for those practising, or intend to practice, in biotechnology. It begins by providing an overview of the administrative organisation and tools of the EC and its member states as a backdrop to a description of key Directives and Guidelines. Topic coverage includes good laboratory and manufacturing practices, safety issues of gene manipulation, the cultivation of micro-organisms, the use of animals, procedures using radioactive isotopes, market authorisation for medicinalproducts and food ingredients and intellectual property rights. Primarily designed as a reference source, the added commentaries and distillation of key elements provide a valuable back-up to the technical texts of the BIOTOL series.
Audience: Anyone involved in the biosciences in industry and education who needs a resource containing all relevant regulatory information.
Editorials
Booknews
Following an introduction to the general structure, tools, and legislation of the European Community, and the legislation of direct relevance to biotechnology, the bulk of this text deals with legal and operational issues which have generic application in biotechnology. The issues of intellectual property rights are also explained. Finally, issues regarding the marketing of biotechnological products and process in health care, food processing, and chemical production are addressed. Annotation c. Book News, Inc., Portland, OR (booknews.com)Book Details
Published
January 1, 1994
Publisher
Oxford ; Butterworth-Heinemann, 1993.
Pages
318
Format
Paperback
ISBN
9780750616003