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Biochemical preparations
| Biochemical preparations |
| Pubbl/distr/stampa | New York, : Wiley |
| Disciplina | 612.015072 |
| ISSN | 0067-8686 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-990008918280403321 |
| New York, : Wiley | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 |
Gregersen Jens-Peter
|
||
| Weinheim ; ; New York, : VCH, c1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
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 |
|
Gregersen Jens-Peter
|
||
| Weinheim ; ; New York, : VCH, c1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
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. | UNINA-9910830126903321 |
|
Gregersen Jens-Peter
|
||
| Weinheim ; ; New York, : VCH, c1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Research and development of vaccines and pharmaceuticals from biotechnology : a guide to effective project management, patenting, and product registration / / Jens-Peter Gregersen
| Research and development of vaccines and pharmaceuticals from biotechnology : 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 |
9786611758790
9781281758798 1281758795 9783527615834 3527615830 9783527615827 3527615822 |
| 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-9911019364903321 |
|
Gregersen Jens-Peter
|
||
| Weinheim ; ; New York, : VCH, c1994 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||