Research and Development of Vaccines and Pharmaceuticals from Biotechnology
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.
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Biotechnology in Pharmaceutical Research
The Aim of a Project
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active ingredient adjuvants analytical animals Annex antibodies antigen applied research approval aspects authorities basic biological products biotechnology budget clinical trials cost countries decision defined detailed documentation dose toxicity drugs effects essential European Patent European Patent Convention evaluation example excipients filing formal guidelines human immunological Immunotoxicity individual industrial inventor investigations Japan licence limited major Manufacturing Practice manufacturing process methods microorganisms monoclonal antibodies necessary objectives organizations patent application patent claims patent examiner patent office patent protection patentable invention patentable subject matter pharmaceutical products Pharmacodynamic pharmacokinetic pharmacological phase polypeptides potential preclinical prior art priority date procedures product development product profile project manager project plan protein recombinant recommended Registration Requirements regulations regulatory reports residue risk safety and efficacy safety tests scientific specific standards starting materials studies substances target species technical therapeutic usually veterinary medicinal products veterinary products