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Biosimilar clinical development : scientific considerations and new methodologies / / edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston Uni
| Biosimilar clinical development : scientific considerations and new methodologies / / edited by Kerry B. Barker, Pfizer, Cambridge, Massachusetts, USA, Sandeep M. Menon, Pfizer, Cambridge, Massachusetts, USA, Ralph B. D'Agostino, Sr., Boston Uni |
| Pubbl/distr/stampa | Boca Raton : , : Taylor & Francis, , [2017] |
| Descrizione fisica | 1 online resource (269 pages) |
| Disciplina | 615.1/9 |
| Collana | Chapman & Hall/CRC Biostatistics Series |
| Soggetto topico |
Biologicals
Drug development - Methodology |
| ISBN |
1-315-37326-2
1-315-35590-6 1-4822-3170-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 1. Biosimilars for drug development : the time is now! / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Ralph B. D'Agostino -- 2. From isolation to integration : a systems biology approach for the discovery of therapeutic targets and biomarkers / Attila Seyhan and Claudio Carini -- 3. Immunogenicity of biological products : current perspectives and future implications / Candida Fratazzi, Attila Seyhan, and Claudio Carini -- 4. Interchangeability between biosimilar and innovator drug products / Bo Jin, Sandeep M. Menon, Kerry B. Barker, and Steven Ye Hua -- 5. Bridging a new biological product with its reference product /Jianjun (David) Li and Jin Xu -- 6. Accounting for covariate effect to show noninferiority in biosimilars / Siyan Xu, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 7. Novel method in inference of equivalence in biosimilars / Siyan Xu, Steven Ye Hua, Ronald Menton, Kerry B. Barker, Sandeep M. Menon, and Ralph B. D'Agostino -- 8. Multiplicity adjustments in testing for bioequivalence / Steven Ye Hua, Siyan Xu, and Ralph B. D'Agostino -- 9. Bayesian methods to assess bioequivalence and biosimilarity with case studies / Steven Ye Hua, Siyan Xu, Kerry B. Barker, Shan Mei Liao, and Shujie Li -- 10. Average inferiority measure and standardized margins to address the issues in biosimilar trials / Gang Li and Weichung Joe Shih -- 11. Bayesian methods for design and analysis of noninferiority trials / Mani Lakshminarayanan and Fanni Natanegara. |
| Record Nr. | UNINA-9910153182903321 |
| Boca Raton : , : Taylor & Francis, , [2017] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Fundamentals of drug development / / Jeffrey S. Barrett
| Fundamentals of drug development / / Jeffrey S. Barrett |
| Autore | Barrett Jeffrey S. |
| Pubbl/distr/stampa | Newark : , : John Wiley & Sons, Incorporated, , 2022 |
| Descrizione fisica | 1 online resource (512 pages) |
| Soggetto topico |
Drug development - Methodology
Pharmaceutical technology - Methodology Drugs - Research |
| Soggetto genere / forma | ebook |
| ISBN |
1-119-91327-6
1-119-69173-7 1-119-69170-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | The history of drug development -- The modern pharmaceutical industry : big and small pharma, biotechnology companies, and generic drug makers -- Legal considerations, intellectual property, patents and patent protection -- The global regulatory landscape -- Phases of drug development : old and new paradigms -- Discovery / preclinical -- Phase I -- Phase II -- Phase III -- Phase IV, special populations and post marketing commitments -- Role and function of project teams -- Compound progression and go / no go criteria -- Regulatory milestones and the submission process -- Life cycle management -- Formulation development -- Chemistry and manufacturing (CMC) -- Health economics and the healthcare industry -- Current state of affairs : attrition rates and evolving corporate strategies -- Medical devices -- Distribution and the supply chain -- Sales, marketing and advertising -- Generic drugs and the generic industry -- The generic approval process -- Data sharing and collaboration -- The future of the pharmaceutical industry. |
| Record Nr. | UNINA-9910590095803321 |
Barrett Jeffrey S.
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| Newark : , : John Wiley & Sons, Incorporated, , 2022 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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LC/MS applications in drug development [[electronic resource] /] / Mike S. Lee
| LC/MS applications in drug development [[electronic resource] /] / Mike S. Lee |
| Autore | Lee Mike S. <1960-> |
| Pubbl/distr/stampa | New York, : J. Wiley & Sons, c2002 |
| Descrizione fisica | 1 online resource (257 p.) |
| Disciplina |
615.19
615/.19 |
| Collana | Wiley-Interscience series on mass spectrometry |
| Soggetto topico |
Drug development - Methodology
Drugs - Analysis Liquid chromatography Mass spectrometry Combinatorial chemistry Gel permeation chromatography Drugs - Testing - Methodology |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-36642-7
9786610366422 0-470-35636-7 0-471-45930-5 0-471-21881-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
LC/MS APPLICATIONS IN DRUG DEVELOPMENT; CONTENTS; Preface; Acknowledgments; 1. Introduction; Emerging Analytical Needs; Integration of LC/MS into Drug Development; Partnerships and Acceptance; Overview; 2. Drug Development Overview; Analysis Perspectives; The Four Stages of Drug Development; Drug Discovery; Preclinical Development; Clinical Development; Manufacturing; 3. Accelerated Drug Development; Accelerated Development Strategies; Quantitative and Qualitative Process Elements; Quantitative Process Pipeline; Qualitative Process Pipeline; Motivating Factors
Analysis Opportunities for Accelerated DevelopmentFull-Time Equivalent; Sample Throughput Model; Elimination Model; Rate-Determining Event Model; Accelerated Development Perspectives; 4. LC/MS Development; The Elements of LC/MS Application; HPLC; Mass Spectrometry; LC/MS Interface; LC/MS Growth; 5. Strategies; Standard Methods; Template Structure Identification; Databases; Screening; Integration; Miniaturization; Parallel Processing; Visualization; Automation; Summary; 6. LC/MS Applications; Drug Discovery; Proteomics; Protein Expression Profiling; Quantitation; Glycoprotein Mapping Natural Products DereplicationLead Identification Screening; Bioaffinity Screening; Combinatorial Library Screening; Open-Access LC/MS; Structure Confirmation; High Throughput; Purification; Combinatorial Mixture Screening; In Vivo Drug Screening; Pharmacokinetics; In Vitro Drug Screening; Metabolic Stability Screening; Membrane Permeability; Drug-Drug Interaction; Metabolite Identification; Preclinical Development; Metabolite Identification; Impurity Identification; Degradant Identification; Clinical Development; Quantitative Bioanalysis-Selected Ion Monitoring Quantitative Bioanalysis-Selected Reaction MonitoringQuantitative Bioanalysis-Automated Solid-Phase Extraction; Quantitative Bioanalysis-Automated On-Line Extraction; Metabolite Identification; Degradant Identification; Manufacturing; Impurity Identification Using Data-Dependent Analysis; Peptide Mapping in Quality Control; Patent Protection; 7. Future Applications and Prospects; Workstations; Multidimensional Analysis; Miniaturization; Information Management; Strategic Outsourcing; Summary; 8. Perspectives on the Future Growth of LC/MS; 9. Conclusions; Glossary; References; Index |
| Record Nr. | UNINA-9910143176103321 |
|
Lee Mike S. <1960->
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||
| New York, : J. Wiley & Sons, c2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
LC/MS applications in drug development [[electronic resource] /] / Mike S. Lee
| LC/MS applications in drug development [[electronic resource] /] / Mike S. Lee |
| Autore | Lee Mike S. <1960-> |
| Pubbl/distr/stampa | New York, : J. Wiley & Sons, c2002 |
| Descrizione fisica | 1 online resource (257 p.) |
| Disciplina |
615.19
615/.19 |
| Collana | Wiley-Interscience series on mass spectrometry |
| Soggetto topico |
Drug development - Methodology
Drugs - Analysis Liquid chromatography Mass spectrometry Combinatorial chemistry Gel permeation chromatography Drugs - Testing - Methodology |
| ISBN |
1-280-36642-7
9786610366422 0-470-35636-7 0-471-45930-5 0-471-21881-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
LC/MS APPLICATIONS IN DRUG DEVELOPMENT; CONTENTS; Preface; Acknowledgments; 1. Introduction; Emerging Analytical Needs; Integration of LC/MS into Drug Development; Partnerships and Acceptance; Overview; 2. Drug Development Overview; Analysis Perspectives; The Four Stages of Drug Development; Drug Discovery; Preclinical Development; Clinical Development; Manufacturing; 3. Accelerated Drug Development; Accelerated Development Strategies; Quantitative and Qualitative Process Elements; Quantitative Process Pipeline; Qualitative Process Pipeline; Motivating Factors
Analysis Opportunities for Accelerated DevelopmentFull-Time Equivalent; Sample Throughput Model; Elimination Model; Rate-Determining Event Model; Accelerated Development Perspectives; 4. LC/MS Development; The Elements of LC/MS Application; HPLC; Mass Spectrometry; LC/MS Interface; LC/MS Growth; 5. Strategies; Standard Methods; Template Structure Identification; Databases; Screening; Integration; Miniaturization; Parallel Processing; Visualization; Automation; Summary; 6. LC/MS Applications; Drug Discovery; Proteomics; Protein Expression Profiling; Quantitation; Glycoprotein Mapping Natural Products DereplicationLead Identification Screening; Bioaffinity Screening; Combinatorial Library Screening; Open-Access LC/MS; Structure Confirmation; High Throughput; Purification; Combinatorial Mixture Screening; In Vivo Drug Screening; Pharmacokinetics; In Vitro Drug Screening; Metabolic Stability Screening; Membrane Permeability; Drug-Drug Interaction; Metabolite Identification; Preclinical Development; Metabolite Identification; Impurity Identification; Degradant Identification; Clinical Development; Quantitative Bioanalysis-Selected Ion Monitoring Quantitative Bioanalysis-Selected Reaction MonitoringQuantitative Bioanalysis-Automated Solid-Phase Extraction; Quantitative Bioanalysis-Automated On-Line Extraction; Metabolite Identification; Degradant Identification; Manufacturing; Impurity Identification Using Data-Dependent Analysis; Peptide Mapping in Quality Control; Patent Protection; 7. Future Applications and Prospects; Workstations; Multidimensional Analysis; Miniaturization; Information Management; Strategic Outsourcing; Summary; 8. Perspectives on the Future Growth of LC/MS; 9. Conclusions; Glossary; References; Index |
| Record Nr. | UNINA-9910830729403321 |
|
Lee Mike S. <1960->
|
||
| New York, : J. Wiley & Sons, c2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
LC/MS applications in drug development / / Mike S. Lee
| LC/MS applications in drug development / / Mike S. Lee |
| Autore | Lee Mike S. <1960-> |
| Pubbl/distr/stampa | New York, : J. Wiley & Sons, c2002 |
| Descrizione fisica | 1 online resource (257 p.) |
| Disciplina |
615.19
615/.19 |
| Collana | Wiley-Interscience series on mass spectrometry |
| Soggetto topico |
Drug development - Methodology
Drugs - Analysis Liquid chromatography Mass spectrometry Combinatorial chemistry Gel permeation chromatography Drugs - Testing - Methodology |
| ISBN |
1-280-36642-7
9786610366422 0-470-35636-7 0-471-45930-5 0-471-21881-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
LC/MS APPLICATIONS IN DRUG DEVELOPMENT; CONTENTS; Preface; Acknowledgments; 1. Introduction; Emerging Analytical Needs; Integration of LC/MS into Drug Development; Partnerships and Acceptance; Overview; 2. Drug Development Overview; Analysis Perspectives; The Four Stages of Drug Development; Drug Discovery; Preclinical Development; Clinical Development; Manufacturing; 3. Accelerated Drug Development; Accelerated Development Strategies; Quantitative and Qualitative Process Elements; Quantitative Process Pipeline; Qualitative Process Pipeline; Motivating Factors
Analysis Opportunities for Accelerated DevelopmentFull-Time Equivalent; Sample Throughput Model; Elimination Model; Rate-Determining Event Model; Accelerated Development Perspectives; 4. LC/MS Development; The Elements of LC/MS Application; HPLC; Mass Spectrometry; LC/MS Interface; LC/MS Growth; 5. Strategies; Standard Methods; Template Structure Identification; Databases; Screening; Integration; Miniaturization; Parallel Processing; Visualization; Automation; Summary; 6. LC/MS Applications; Drug Discovery; Proteomics; Protein Expression Profiling; Quantitation; Glycoprotein Mapping Natural Products DereplicationLead Identification Screening; Bioaffinity Screening; Combinatorial Library Screening; Open-Access LC/MS; Structure Confirmation; High Throughput; Purification; Combinatorial Mixture Screening; In Vivo Drug Screening; Pharmacokinetics; In Vitro Drug Screening; Metabolic Stability Screening; Membrane Permeability; Drug-Drug Interaction; Metabolite Identification; Preclinical Development; Metabolite Identification; Impurity Identification; Degradant Identification; Clinical Development; Quantitative Bioanalysis-Selected Ion Monitoring Quantitative Bioanalysis-Selected Reaction MonitoringQuantitative Bioanalysis-Automated Solid-Phase Extraction; Quantitative Bioanalysis-Automated On-Line Extraction; Metabolite Identification; Degradant Identification; Manufacturing; Impurity Identification Using Data-Dependent Analysis; Peptide Mapping in Quality Control; Patent Protection; 7. Future Applications and Prospects; Workstations; Multidimensional Analysis; Miniaturization; Information Management; Strategic Outsourcing; Summary; 8. Perspectives on the Future Growth of LC/MS; 9. Conclusions; Glossary; References; Index |
| Record Nr. | UNINA-9910877682203321 |
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Lee Mike S. <1960->
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| New York, : J. Wiley & Sons, c2002 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Privileged structures in drug discovery : medicinal chemistry and synthesis / / Dr. Larry Yet, University of South Alabama, USA
| Privileged structures in drug discovery : medicinal chemistry and synthesis / / Dr. Larry Yet, University of South Alabama, USA |
| Autore | Yet Larry |
| Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley, , 2018 |
| Descrizione fisica | 1 online resource (561 pages) |
| Disciplina | 615.1/9 |
| Soggetto topico |
Pharmaceutical chemistry
Drug development - Methodology |
| ISBN |
1-118-68633-0
1-118-68635-7 1-118-68626-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910270869303321 |
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Yet Larry
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| Hoboken, New Jersey : , : Wiley, , 2018 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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