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Biomaterials and Biopolymers / / edited by Avi Domb, Boaz Mizrahi, Shady Farah
| Biomaterials and Biopolymers / / edited by Avi Domb, Boaz Mizrahi, Shady Farah |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (280 pages) |
| Disciplina | 610.28 |
| Collana | AAPS Introductions in the Pharmaceutical Sciences |
| Soggetto topico |
Pharmaceutical chemistry
Biomaterials Pharmacology Drug delivery systems Vaccines - Biotechnology Pharmaceutics Drug Delivery Biomaterials-Vaccines |
| ISBN | 3-031-36135-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction to Biomaterials -- Biodegradable Polymers -- Natural and semi-natural polymers -- Fundamentals and Biomedical Applications of Smart Hydrogels -- Engineering biomaterials for nucleic acid-based therapies -- Mechanics of Biomaterials for Regenerative Medicine -- Biomaterials for controlled drug delivery applications -- BIOMATERIALS APPLICATION: IMPLANTS -- Living Biomaterials -- Therapeutic Polymer Conjugates and their Characterization -- Biocompatibility of Polymers -- Sterilization techniques of biomaterials (implants and medical devices). |
| Record Nr. | UNINA-9910746300103321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Biopharmaceutical Manufacturing [[electronic resource] ] : Progress, Trends and Challenges / / edited by Ralf Pörtner
| Biopharmaceutical Manufacturing [[electronic resource] ] : Progress, Trends and Challenges / / edited by Ralf Pörtner |
| Autore | Pörtner Ralf |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (497 pages) |
| Disciplina | 571.6 |
| Collana | Cell Engineering |
| Soggetto topico |
Cytology
Biomedical engineering Biotechnology Biochemical engineering Pharmaceutical chemistry Vaccines - Biotechnology Biomaterials Cell Biology Biomedical Engineering and Bioengineering Bioprocess Engineering Pharmaceutics Biomaterials-Vaccines |
| ISBN | 3-031-45669-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I: Manufacturing of Recombinant Therapeutic Proteins -- Chapter 1. Single-Use Systems in Biopharmaceutical Manufacture: State of the Art and Recent Trends (Jossen et al.) -- Chapter 2. Recent Developments in Bioprocess Monitoring Systems (Rahmatnejad et al.) -- Chapter 3. Advances in Characterization of Industrial Bioreactors for Cell Culture Process (Fitschen et al.) -- Chapter 4. Continuous Bioprocessing for Upstream Process - Perfusion Process (Chotteau et al.) -- Chapter 5. Continuous Bioprocessing for Downstream (Gerstweiler) -- Chapter 6. Towards Digital Twin for Biopharmaceutical Processes: Concept and Progress (Ding et al.) -- Chapter 7. Integrated Process and Supply Chain Design and Optimization (Triantafyllou et al.) -- Chapter 8. Production of Complex Proteins in Plants – From Farming to Manufacturing (Nausch et al.) -- Chapter 9. Manufacturing of Recombinant Proteins Using Quality by Design (QbD) Methodology: Current Trend and Challenges (Shin and Landauer) -- Chapter 10. Biopharma 4.0 for Biologics Manufacturing Under Pandemic Constraints (Schmidt et al.) -- Chapter 11. Biopharma 4.0: Digital Technologies Driving Smart Manufacturing (Nargund et al.) -- Part II: Manufacturing Aspects of Cell and Gene Therapy -- Chapter 12. Essential Aspects of Mesenchymal Stem Cell Manufacturing (Fleischhammer et al.) -- Chapter 13. Towards a Continuous Production of Human Mesenchymal Stromal Cells in a Chemically Defined Medium: Opportunities and Challenges for a Robust and Scalable Expansion Process (Tasto and Salzig) -- Chapter 14. Biomanufacturing Aspects of Gene Therapy (Warnock) -- Chapter 15. Manufacturing and Quality of Advanced Therapeutics: Cellular Therapies, CAR-T and Gene Therapies (van den Bos et al.). |
| Record Nr. | UNINA-9910800113003321 |
Pörtner Ralf
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| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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COVID-19: Search for a vaccine / / by Patric U. B. Vogel
| COVID-19: Search for a vaccine / / by Patric U. B. Vogel |
| Autore | Vogel Patric U. B. |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Wiesbaden : , : Springer Fachmedien Wiesbaden : , : Imprint : Springer Spektrum, , 2023 |
| Descrizione fisica | 1 online resource (60 pages) |
| Disciplina | 362.1962414 |
| Collana | essentials |
| Soggetto topico |
Vaccines - Biotechnology
Biomaterials Pharmacy Medicinal chemistry Biomaterials-Vaccines Medicinal Chemistry |
| ISBN |
9783658389314
9783658389307 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction -- Coronaviruses: history and viral properties -- Vaccine technologies, approaches against COVID-19, clinical phases -- Attenuated live vaccines -- Vector vaccines and virus-like particles -- Inactivated vaccines -- Recombinant proteins (protein subunits) -- Nucleic acid-based vaccines -- Other aspects - One vaccine for all? - Herd immunity - Duration of immunity - Sterilizing immunity -- Summary. |
| Record Nr. | UNINA-9910633930303321 |
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Vogel Patric U. B.
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| Wiesbaden : , : Springer Fachmedien Wiesbaden : , : Imprint : Springer Spektrum, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Genomics, proteomics, and vaccines [[electronic resource] /] / editor, Guido Grandi
| Genomics, proteomics, and vaccines [[electronic resource] /] / editor, Guido Grandi |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2004 |
| Descrizione fisica | 1 online resource (345 p.) |
| Disciplina | 572.8/6 |
| Altri autori (Persone) | GrandiGuido |
| Soggetto topico |
Genomics
Vaccines - Biotechnology Proteomics |
| ISBN |
1-280-26948-0
9786610269488 0-470-09392-7 0-470-01253-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Genomics, Proteomics and Vaccines -- Contents -- Preface -- List of contributors -- PART 1: INTRODUCTION -- 1 Vaccination: Past, Present and Future -- 1.1 Introduction -- 1.2 Vaccination: the past -- 1.3 Vaccination: the present -- 1.4 Vaccination: the future -- 1.5 Conclusion: the intangible value of vaccination -- 2 Bioinformatics, DNA Microarrays and Proteomics in Vaccine Discovery: Competing or Complementary Technologies? -- 2.1 Introduction -- 2.2 From genome sequence to vaccine discovery -- 2.3 A case study: the anti-meningococcus B vaccine -- 2.4 Comparison of the three approaches -- 2.5 Conclusions: a 'nomics' approach to vaccine discovery -- PART 2: TECHNOLOGIES -- 3 Genome Sequencing and Analysis -- 3.1 Introduction -- 3.2 Genome sequencing -- 3.3 Genome analysis -- 3.4 Conclusion -- 4 Understanding DNA Microarrays: Sources and Magnitudes of Variances in DNA Microarray Data Sets -- 4.1 Introduction -- 4.2 DNA array formats -- 4.3 Data analysis methods -- 4.4 Sources and magnitudes of noise in DNA microarray experiments -- 4.5 Conclusions -- Acknowledgements -- 5 The Proteome, Anno Domini Two Zero Zero Three -- 5.1 Introduction -- 5.2 Some definitions -- 5.3 What methods exist to tackle the proteome complexity?5.4 Quantitative proteomics -- 5.5 Pre-fractionation in proteome analysis -- 5.6 Multi-dimensional chromatography -- 5.7 Protein chip arrays -- 5.8 Imaging mass spectrometry -- Acknowledgements -- 6 Mass Spectrometry in Proteomics -- 6.1 Introduction -- 6.2 MS technology -- 6.3 Principle of protein identification based on MS data -- 6.4 Proteomics workflows -- 7 High Throughput Cloning, Expression and Purification Technologies -- 7.1 Introduction -- 7.2 Gene cloning -- 7.3 Protein expression -- 7.4 High-throughput protein purification -- 7.5 Validation of the pipeline and outlook7.6 Conclusion -- PART 3: APPLICATIONS -- 8 Meningococcus B: from Genome to Vaccine -- 8.1 Meningococcus, a major cause of bacterial meningitis -- 8.2 Group B meningococcus as an example of reverse vaccinology -- 8.3 Conclusions -- 9 Vaccines Against Pathogenic Streptococci -- 9.1 Introduction -- 9.2 Comparative genomics of streptococci -- 9.3 A vaccine against group B streptococcus -- 9.4 A vaccine against group A streptococcus -- 9.5 Conclusions -- 10 Identification of the 'Antigenome' - a Novel Tool for Design and Development of Subunit Vaccines Against Bacterial Pathogens -- 10.1 Introduction -- 10.2 Small DNA insert libraries - a tool to cover a pathogen's 'antigenome' -- 10.3 Proper display platforms -- 10.4 Selected human sera to provide imprints of pathogen encounters -- 10.5 Cognate antibodies reveal the 'antigenome' of a pathogen -- 10.6 How to retrieve from the 'antigenome' the candidate antigens for vaccine development -- 10.7 Summary and discussion -- 11 Searching the Chlamydia Genomes for New Vaccine Candidates -- 11.1 Old problems and new perspectives for chlamydial vaccines. |
| Record Nr. | UNINA-9910145752603321 |
| Chichester ; ; Hoboken, NJ, : Wiley, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Genomics, proteomics, and vaccines / / editor, Guido Grandi
| Genomics, proteomics, and vaccines / / editor, Guido Grandi |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Chichester ; ; Hoboken, NJ, : Wiley, c2004 |
| Descrizione fisica | 1 online resource (345 p.) |
| Disciplina | 572.8/6 |
| Altri autori (Persone) | GrandiGuido |
| Soggetto topico |
Genomics
Vaccines - Biotechnology Proteomics |
| ISBN |
1-280-26948-0
9786610269488 0-470-09392-7 0-470-01253-6 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Genomics, Proteomics and Vaccines -- Contents -- Preface -- List of contributors -- PART 1: INTRODUCTION -- 1 Vaccination: Past, Present and Future -- 1.1 Introduction -- 1.2 Vaccination: the past -- 1.3 Vaccination: the present -- 1.4 Vaccination: the future -- 1.5 Conclusion: the intangible value of vaccination -- 2 Bioinformatics, DNA Microarrays and Proteomics in Vaccine Discovery: Competing or Complementary Technologies? -- 2.1 Introduction -- 2.2 From genome sequence to vaccine discovery -- 2.3 A case study: the anti-meningococcus B vaccine -- 2.4 Comparison of the three approaches -- 2.5 Conclusions: a 'nomics' approach to vaccine discovery -- PART 2: TECHNOLOGIES -- 3 Genome Sequencing and Analysis -- 3.1 Introduction -- 3.2 Genome sequencing -- 3.3 Genome analysis -- 3.4 Conclusion -- 4 Understanding DNA Microarrays: Sources and Magnitudes of Variances in DNA Microarray Data Sets -- 4.1 Introduction -- 4.2 DNA array formats -- 4.3 Data analysis methods -- 4.4 Sources and magnitudes of noise in DNA microarray experiments -- 4.5 Conclusions -- Acknowledgements -- 5 The Proteome, Anno Domini Two Zero Zero Three -- 5.1 Introduction -- 5.2 Some definitions -- 5.3 What methods exist to tackle the proteome complexity?5.4 Quantitative proteomics -- 5.5 Pre-fractionation in proteome analysis -- 5.6 Multi-dimensional chromatography -- 5.7 Protein chip arrays -- 5.8 Imaging mass spectrometry -- Acknowledgements -- 6 Mass Spectrometry in Proteomics -- 6.1 Introduction -- 6.2 MS technology -- 6.3 Principle of protein identification based on MS data -- 6.4 Proteomics workflows -- 7 High Throughput Cloning, Expression and Purification Technologies -- 7.1 Introduction -- 7.2 Gene cloning -- 7.3 Protein expression -- 7.4 High-throughput protein purification -- 7.5 Validation of the pipeline and outlook7.6 Conclusion -- PART 3: APPLICATIONS -- 8 Meningococcus B: from Genome to Vaccine -- 8.1 Meningococcus, a major cause of bacterial meningitis -- 8.2 Group B meningococcus as an example of reverse vaccinology -- 8.3 Conclusions -- 9 Vaccines Against Pathogenic Streptococci -- 9.1 Introduction -- 9.2 Comparative genomics of streptococci -- 9.3 A vaccine against group B streptococcus -- 9.4 A vaccine against group A streptococcus -- 9.5 Conclusions -- 10 Identification of the 'Antigenome' - a Novel Tool for Design and Development of Subunit Vaccines Against Bacterial Pathogens -- 10.1 Introduction -- 10.2 Small DNA insert libraries - a tool to cover a pathogen's 'antigenome' -- 10.3 Proper display platforms -- 10.4 Selected human sera to provide imprints of pathogen encounters -- 10.5 Cognate antibodies reveal the 'antigenome' of a pathogen -- 10.6 How to retrieve from the 'antigenome' the candidate antigens for vaccine development -- 10.7 Summary and discussion -- 11 Searching the Chlamydia Genomes for New Vaccine Candidates -- 11.1 Old problems and new perspectives for chlamydial vaccines. |
| Record Nr. | UNINA-9910828470503321 |
| Chichester ; ; Hoboken, NJ, : Wiley, c2004 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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History of Rabies in the Americas: From the Pre-Columbian to the Present, Volume I : Insights to Specific Cross-Cutting Aspects of the Disease in the Americas / / edited by Charles E. Rupprecht
| History of Rabies in the Americas: From the Pre-Columbian to the Present, Volume I : Insights to Specific Cross-Cutting Aspects of the Disease in the Americas / / edited by Charles E. Rupprecht |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (328 pages) |
| Disciplina | 616.953 |
| Collana | Fascinating Life Sciences |
| Soggetto topico |
Immunology
Virology Medicine - History Veterinary medicine Vaccines - Biotechnology Biomaterials History of Medicine Veterinary Science Biomaterials-Vaccines |
| ISBN |
9783031250521
9783031250514 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The world in flux – the Columbian Exchange D. Domenici -- Glimpses into the past: new world contributions towards understanding the basic etiology, pathobiology & treatment of rabies, Drishya Kurup et al -- The Diversity, Evolution and Emergence of Rabies Virus in the Americas, Edward C. Holmes & Erin H. Harvey -- The ecological range and principles of wildlife rabies virus perpetuation in the Americas, Amy T. Gilbert -- Historical Laboratory Contributions Supporting Rabies Diagnosis and Disease Prevention and Control in the Americas, Susan A. Nadin-Davis, et al -- Progression from nerve tissue vaccines to recombinant biologics, H. Ertl -- Wildlife Rabies Management in the New World: Prevention, Control and Elimination in Mesocarnivores, R. Chipman et al -- Management of vampire bats and rabies: past, present, and future, Tonie Rocke & Daniel Streicker -- Conflicting Perspectives on a Rabies Outbreak in a Venezuelan Rainforest, 2007-2008, C. Briggs -- Rabies, Medicine, and Culture: Dogs, Disease, and Urban Life in the United States, 1840-1920, Jessica Wang -- Historical disparities in health: rabies surveillance, risk factors and prevention, Amira Roess et al -- The Health Economics of Rabies in the Americas: An Historical Summary and a Synthesis of the Literature, S.A. Shwiff -- Towards the elimination of canine rabies in the americas: governance of a regional program, M. Vigilato et al -- Musing Over Non-technical Criticalities of Rabies Prevention and Control in the Americas, Victor J. Del Rio Vilas & Gilberto Montibeller. |
| Record Nr. | UNINA-9910717416703321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Modern Biomedical Applications of Magnetic Nanoparticles / / by Mari Takahashi, The Son Le, Shinya Maenosono
| Modern Biomedical Applications of Magnetic Nanoparticles / / by Mari Takahashi, The Son Le, Shinya Maenosono |
| Autore | Takahashi Mari |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (103 pages) |
| Disciplina | 610.28 |
| Collana | SpringerBriefs in Molecular Science |
| Soggetto topico |
Nanoparticles
Magnetic Materials Imaging systems in biology Microfluidics Vaccines - Biotechnology Biomaterials Biology - Technique Genetic engineering Biological Imaging Biomaterials-Vaccines Gene Delivery |
| ISBN | 981-19-7104-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Traditional Applications of Magnetic Nanoparticles in Clinical Diagnostic and Therapeutics -- 2. Modern Biomedical Applications of Magnetic Nanoparticles -- 3. Concluding Remarks and Future Perspectives. |
| Record Nr. | UNINA-9910629275603321 |
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Takahashi Mari
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| Singapore : , : Springer Nature Singapore : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Novel immune potentiators and delivery technologies for next generation vaccines / / Manmohan Singh, editor
| Novel immune potentiators and delivery technologies for next generation vaccines / / Manmohan Singh, editor |
| Edizione | [1st ed. 2013.] |
| Pubbl/distr/stampa | New York, : Springer, c2013 |
| Descrizione fisica | 1 online resource (367 p.) |
| Disciplina | 615.6 |
| Altri autori (Persone) | Manmohan Singh <1964 November 8-> |
| Soggetto topico |
Immunology
Vaccines - Biotechnology Vaccines |
| ISBN | 1-4614-5380-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Critical parameters that govern the optimization of vaccine formulations -- Development of Biophysical assays to better understand vaccine formulation stability -- Rational design of vaccine formulations -- Monitoring stability and efficacy of multi-valent vaccine formulations.- Overcoming challenges of multi component alum formulations.- Delivery of various TLR adjuvants using alum platform -- History of use of emulsions for vaccine delivery -- MF59 o/w emulsion : History and safety over the last 2 decades -- Optimizing novel nanoemulsions for delivery of next generation antigens and adjuvants -- Modulating vaccine responses with innate immunity : Use of PLGA nanoparticles for delivering multiple TLR agonists -- Shape matters : Role of nanoparticle shape in induction of immune responses to a vaccine. . |
| Record Nr. | UNINA-9910437605403321 |
| New York, : Springer, c2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Research and development of vaccines and pharmaceuticals from biotechnology [[electronic resource] ] : a guide to effective project management, patenting, and product registration / / Jens-Peter Gregersen
| Research and development of vaccines and pharmaceuticals from biotechnology [[electronic resource] ] : a guide to effective project management, patenting, and product registration / / Jens-Peter Gregersen |
| Autore | Gregersen Jens-Peter |
| Pubbl/distr/stampa | Weinheim ; ; New York, : VCH, c1994 |
| Descrizione fisica | 1 online resource (190 p.) |
| Disciplina |
612.015072
615.372 |
| Soggetto topico |
Biotechnology
Biotechnology - Research Drugs - Research Pharmaceutical biotechnology - Law and legislation Vaccines - Biotechnology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-281-75879-5
9786611758790 3-527-61583-0 3-527-61582-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Research and Development of Vaccines and Pharmaceuticals from Biotechnology; Preface; 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; Time and Task Dependencies; Project Team Approval and Refinement of the Plan; Allocation of Resources and Budget Planning
Changes to the PlanImplementing 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; Risk Oriented Planning; Product Development Phases; Decision Making; The Project Manager; Organizational Structures; Technical Aspects of Product Development; Process Development and Manufacturing; Analytical Development and Quality Assurance; Patents for Biomedicinal Products The Purpose of a PatentAlternatives to Patents; Basic Requirements for a Patentable Invention; Novelty; Non-obviousness; Utility or Industrial Applicability; Inventions, Discoveries and Products of Nature; Patentable Inventions and Exclusions; Product, Process and Use Patents; Dependent Patents; The Patent Application; The Patent Description; Deposition of Microorganisms; Patent Claims; Filing a Patent Application; Priority of Patents and Continuation-in-Part; Duration of Patent Protection; Extension of Patent Terms for Pharmaceuticals; Oppositions against Patents; Patent Costs Patent InformationCheck List for Prospective Patent Applicants; Selling an Invention, Licences and Royalties; Registration Requirements; Three Basic Elements; Quality; Safety; Efficacy; Registration Applications and Procedures; Approval for Clinical Trials; Applications for Market Approval; Registration in the EEC; Registration in the USA; Registration in Japan; Requirements for the Preclinical Pharmacology and Safety Assessment; Exceptions and Variations for Biological Products; New Vaccine Adjuvants and Other Excipients; Pharmacokinetics; Pharmacodynamics; Bioequivalence and Bioavailability Single Dose Toxicity (Acute Toxicity)Repeated Dose Toxicity (Subacute, Chronic Toxicity); Reproduction Toxicity; Mutagenicity; Tumorigenicity (Carcinogenicity); Immunotoxicity; Local Tolerance; Additional Preclinical Studies for Veterinary Products; User Safety; Tolerance in the Target Species; Ecotoxicity; Safety of Residues; Annex A; Outline of Major Registration Requirements; Major Registration Requirements for Human; Medicinal Products, Tables 11-15; Major Registration Requirements for Veterinary; Medicinal Products, Tables 16-21; Annex B References and Information Sources on Regulatory Matters |
| Record Nr. | UNINA-9910144561903321 |
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Gregersen Jens-Peter
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| Weinheim ; ; New York, : VCH, c1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Research and development of vaccines and pharmaceuticals from biotechnology [[electronic resource] ] : a guide to effective project management, patenting, and product registration / / Jens-Peter Gregersen
| Research and development of vaccines and pharmaceuticals from biotechnology [[electronic resource] ] : a guide to effective project management, patenting, and product registration / / Jens-Peter Gregersen |
| Autore | Gregersen Jens-Peter |
| Pubbl/distr/stampa | Weinheim ; ; New York, : VCH, c1994 |
| Descrizione fisica | 1 online resource (190 p.) |
| Disciplina |
612.015072
615.372 |
| Soggetto topico |
Biotechnology
Biotechnology - Research Drugs - Research Pharmaceutical biotechnology - Law and legislation Vaccines - Biotechnology |
| ISBN |
1-281-75879-5
9786611758790 3-527-61583-0 3-527-61582-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Research and Development of Vaccines and Pharmaceuticals from Biotechnology; Preface; 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; Time and Task Dependencies; Project Team Approval and Refinement of the Plan; Allocation of Resources and Budget Planning
Changes to the PlanImplementing 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; Risk Oriented Planning; Product Development Phases; Decision Making; The Project Manager; Organizational Structures; Technical Aspects of Product Development; Process Development and Manufacturing; Analytical Development and Quality Assurance; Patents for Biomedicinal Products The Purpose of a PatentAlternatives to Patents; Basic Requirements for a Patentable Invention; Novelty; Non-obviousness; Utility or Industrial Applicability; Inventions, Discoveries and Products of Nature; Patentable Inventions and Exclusions; Product, Process and Use Patents; Dependent Patents; The Patent Application; The Patent Description; Deposition of Microorganisms; Patent Claims; Filing a Patent Application; Priority of Patents and Continuation-in-Part; Duration of Patent Protection; Extension of Patent Terms for Pharmaceuticals; Oppositions against Patents; Patent Costs Patent InformationCheck List for Prospective Patent Applicants; Selling an Invention, Licences and Royalties; Registration Requirements; Three Basic Elements; Quality; Safety; Efficacy; Registration Applications and Procedures; Approval for Clinical Trials; Applications for Market Approval; Registration in the EEC; Registration in the USA; Registration in Japan; Requirements for the Preclinical Pharmacology and Safety Assessment; Exceptions and Variations for Biological Products; New Vaccine Adjuvants and Other Excipients; Pharmacokinetics; Pharmacodynamics; Bioequivalence and Bioavailability Single Dose Toxicity (Acute Toxicity)Repeated Dose Toxicity (Subacute, Chronic Toxicity); Reproduction Toxicity; Mutagenicity; Tumorigenicity (Carcinogenicity); Immunotoxicity; Local Tolerance; Additional Preclinical Studies for Veterinary Products; User Safety; Tolerance in the Target Species; Ecotoxicity; Safety of Residues; Annex A; Outline of Major Registration Requirements; Major Registration Requirements for Human; Medicinal Products, Tables 11-15; Major Registration Requirements for Veterinary; Medicinal Products, Tables 16-21; Annex B References and Information Sources on Regulatory Matters |
| Record Nr. | UNISA-996198798903316 |
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Gregersen Jens-Peter
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| Weinheim ; ; New York, : VCH, c1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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