Info
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals / / by John Geigert
| The Challenge of CMC Regulatory Compliance for Biopharmaceuticals / / by John Geigert |
| Autore | Geigert John |
| Edizione | [4th ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (597 pages) |
| Disciplina |
615/.19
615.19 |
| Soggetto topico |
Biologicals
Biopharmaceutics Pharmaceutical chemistry Pharmacy Biologics Pharmaceutics Biotecnologia farmacèutica Biofarmàcia Indústria farmacèutica Toxicologia Control de qualitat |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-031-31909-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Biopharmaceutical Landscape -- Regulatory Pathways Impacting Biopharmaceuticals -- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs -- Risk Management of the Minimum CMC Regulatory Compliance Continuum -- Ever-Present Threat of Adventitious Agent Contamination -- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance -- Upstream Production of the Biopharmaceutical Drug Substance -- Downstream Purification of the Biopharmaceutical Drug Substance -- Manufacturing the Biopharmaceutical Drug Product -- Complex Process-Related Impurity Profiles -- Seemingly Endless Biomolecular Structural Variants -- Indispensable Potency (Biological Activity) -- Biopharmaceutical Critical Quality Attributes -- The Art of Setting Biopharmaceutical Specifications – Release and Shelf-Life -- The Challenge of Demonstrating Biopharmaceutical Product Comparability -- Strategic CMC-Focused Interactions with Regulatory Authorities. |
| Record Nr. | UNINA-9910731488803321 |
Geigert John
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| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Frontiers in Statistical Quality Control 13 [[electronic resource] /] / edited by Sven Knoth, Wolfgang Schmid
| Frontiers in Statistical Quality Control 13 [[electronic resource] /] / edited by Sven Knoth, Wolfgang Schmid |
| Edizione | [1st ed. 2021.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2021 |
| Descrizione fisica | 1 online resource (XVI, 406 p. 132 illus., 86 illus. in color.) |
| Disciplina | 658.562 |
| Collana | Frontiers in Statistical Quality Control |
| Soggetto topico |
Statistics
Security systems Data mining Biometry Mathematical statistics - Data processing Statistics in Engineering, Physics, Computer Science, Chemistry and Earth Sciences Security Science and Technology Data Mining and Knowledge Discovery Biostatistics Statistics in Business, Management, Economics, Finance, Insurance Statistics and Computing Control de qualitat Estadística matemàtica |
| Soggetto genere / forma |
Congressos
Llibres electrònics |
| ISBN | 3-030-67856-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Part I Statistical Process Control -- Chapter 1 -- Use of the Conditional False Alarm Metric in Statistical Process Monitoring -- Chapter 2 Design Considerations and Tradeoffs for Shewhart Control Charts -- Chapter 3 On the Calculation of the ARL for Beta EWMA Control Charts -- Chapter 4 Flexible Monitoring Methods for High-Yield Processes -- Chapter 5 An Average Loss Control Chart Under a Skewed Process Distribution -- Chapter 6 ARL-unbiased CUSUM schemes to monitor binomial counts -- Chapter 7 Statistical Aspects of Target Setting for Attribute Data Monitoring -- Chapter 8 MAV control charts for monitoring two-state processes using indirectly observed binary data -- Chapter 9 Monitoring Image Processes – Overview and Comparison Study -- Chapter 10 Parallelized Monitoring of Dependent Spatiotemporal Processes -- Chapter 11 Product’s Warranty Claim Monitoring under Variable Intensity Rates -- Chapter 12 A Statistical (Process Monitoring) Perspective on Human Performance Modeling in the Age of Cyber-Physical Systems -- Chapter 13 Monitoring Performance of Surgeons Using a New Risk-adjusted Exponentially Weighted Moving Average Control Chart -- Chapter 14 Exploring the usefulness of Functional Data Analysis for Health Surveillance -- Chapter 15 Rapid Detection of Hot-spot by Tensor Decomposition with Application to Weekly Gonorrhea Data -- Chapter 16 An approach to monitoring time between events when events are frequent -- Part II Selected Topics from Statistical Quality Control -- Chapter 17 Analysis of Measurement Precision Experiment with Ordinal Categorical Variables -- Chapter 18 Assessing a Binary Measurement System with Operator and Random Part Effects -- Chapter 19 Concepts, Methods and Tools Enabling Measurement Quality -- Chapter 20 Assessing laboratory effects in key comparisons with two transfer standards measured in two petals: A Bayesian approach -- Chapter 21 Quality control activities are a challenge for reducing variability -- Chapter 22 Is the Benford Law useful for Data Quality Assessment? |
| Record Nr. | UNISA-996466415803316 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2021 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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Improving processes for health care delivery : lessons from Johns Hopkins Medicine / / Chester Chambers, Maqbool Dada, and Kayode Williams
| Improving processes for health care delivery : lessons from Johns Hopkins Medicine / / Chester Chambers, Maqbool Dada, and Kayode Williams |
| Autore | Chambers Chester |
| Pubbl/distr/stampa | Cham, Switzerland : , : Springer, , [2022] |
| Descrizione fisica | 1 online resource (268 pages) |
| Disciplina | 949.703 |
| Soggetto topico |
Medical care - Quality control
Assistència sanitària Control de qualitat |
| Soggetto genere / forma | Llibres electrònics |
| ISBN | 3-031-19043-2 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996495167303316 |
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Chambers Chester
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| Cham, Switzerland : , : Springer, , [2022] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
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International journal of health care quality assurance
| International journal of health care quality assurance |
| Pubbl/distr/stampa | Bradford, England, : MCB University Press |
| Disciplina | 362.1068 |
| Soggetto topico |
Medical care - Quality control
Health services administration Quality Assurance, Health Care Services de santé - Administration Soins médicaux - Évaluation Soins médicaux - Qualité - Contrôle Publications périodiques Soins de santé Dépenses de santé Administration de la santé Gestion de la qualité Salut pública Hospitals Control de qualitat Garantia de qualitat |
| Soggetto genere / forma |
Periodical
periodicals. Periodicals. Périodiques. Revistes electròniques. |
| ISSN | 1758-6542 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Health care quality assurance |
| Record Nr. | UNINA-9910167558803321 |
| Bradford, England, : MCB University Press | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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International journal of quality science
| International journal of quality science |
| Pubbl/distr/stampa | Bradford, England, : MCB University Press, 1996-1998 |
| Disciplina | 658.562 |
| Soggetto topico |
Quality control
Total quality management Qualité totale Publications périodiques Gestion Contrôle de qualité Control de qualitat Qualitat total |
| Soggetto genere / forma |
Periodicals.
Revistes electròniques. |
| ISSN | 1758-6674 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | IJQS |
| Record Nr. | UNINA-9910869201203321 |
| Bradford, England, : MCB University Press, 1996-1998 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Quality assurance journal
| Quality assurance journal |
| Pubbl/distr/stampa | [Chichester], : John Wiley & Sons, ©1996-©2011 |
| Descrizione fisica | 1 online resource |
| Disciplina | 615 |
| Soggetto topico |
Pharmaceutical technology - Quality control
Medical instruments and apparatus industry - Quality control Pollution control industry - Quality control Medical care - Quality control Environmental Medicine - standards Health Occupations - standards Quality Assurance, Health Care Techniques pharmaceutiques - Qualité - Contrôle Médecine - Appareils et instruments - Industrie - Qualité - Contrôle Environnement - Industrie - Qualité - Contrôle Soins médicaux - Qualité - Contrôle Tecnologia farmacèutica Aparells i instruments mèdics Control de qualitat Control de processos Garantia de qualitat |
| Soggetto genere / forma |
Internet resource
Periodicals. Revistes electròniques. |
| ISSN | 1099-1786 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti |
Qual Assur J
QA |
| Record Nr. | UNINA-9910555240803321 |
| [Chichester], : John Wiley & Sons, ©1996-©2011 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Software quality journal
| Software quality journal |
| Pubbl/distr/stampa | [Andover, Hants, United Kingdom], : Chapman & Hall |
| Descrizione fisica | 1 online resource |
| Disciplina | 005.14 |
| Soggetto topico |
Computer software - Quality control
Logiciels - Qualité - Contrôle Computers Programes d'ordinador Control de qualitat |
| Soggetto genere / forma |
Periodicals.
Revistes electròniques. |
| ISSN | 1573-1367 |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910142368603321 |
| [Andover, Hants, United Kingdom], : Chapman & Hall | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Software Quality: Higher Software Quality through Zero Waste Development : 15th International Conference, SWQD 2023, Munich, Germany, May 23-25, 2023, Proceedings / / edited by Daniel Mendez, Dietmar Winkler, Johannes Kross, Stefan Biffl, Johannes Bergsmann
| Software Quality: Higher Software Quality through Zero Waste Development : 15th International Conference, SWQD 2023, Munich, Germany, May 23-25, 2023, Proceedings / / edited by Daniel Mendez, Dietmar Winkler, Johannes Kross, Stefan Biffl, Johannes Bergsmann |
| Edizione | [1st ed. 2023.] |
| Pubbl/distr/stampa | Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 |
| Descrizione fisica | 1 online resource (139 pages) |
| Disciplina | 006.3 |
| Collana | Lecture Notes in Business Information Processing |
| Soggetto topico |
Software engineering
Software engineering - Management Artificial intelligence Software Engineering Software Management Artificial Intelligence Programari Control de qualitat Desenvolupament de programari |
| Soggetto genere / forma |
Congressos
Llibres electrònics |
| ISBN |
9783031314889
9783031314872 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Social Aspects in Software Engineering -- Conflicting Interests in the Hybrid Workplace: Five Perspectives to Consider -- Requirements Engineering -- Requirements Quality vs. Process and Stakeholders’ Well-being: A Case of a Nordic Bank -- Software Defect Prediction -- Outlier Mining Techniques for Software Defect Prediction -- Software Testing -- Applying a Genetic Algorithm for Test Suite Reduction in Industry -- Software Metrics -- A catalog of source code metrics – a tertiary study -- Software Quality Assurance -- Software quality assessment: defect life cycle, software defect profile, its types and misalignments -- Comparing Anomaly Detection and Classification Algorithms: A Case Study in Two Domain. |
| Record Nr. | UNINA-9910725087003321 |
| Cham : , : Springer Nature Switzerland : , : Imprint : Springer, , 2023 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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