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Aggregation of therapeutic proteins [[electronic resource] /] / edited by Wei Wang, Christopher J. Roberts
| Aggregation of therapeutic proteins [[electronic resource] /] / edited by Wei Wang, Christopher J. Roberts |
| Pubbl/distr/stampa | Hoboken, NJ, : Wiley, c2010 |
| Descrizione fisica | 1 online resource (514 p.) |
| Disciplina | 615.5/8 |
| Altri autori (Persone) |
WangWei <1957 Mar. 10->
RobertsChristopher John <1972-> |
| Soggetto topico |
Protein drugs
Aggregation (Chemistry) |
| ISBN |
1-118-04358-8
1-282-70798-1 9786612707988 0-470-76982-3 0-470-76981-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
AGGREGATION OF THERAPEUTIC PROTEINS; CONTENTS; PREFACE; CONTRIBUTORS; CHAPTER 1: Fundamental Structures and Behaviors of Proteins; CHAPTER 2: Protein Aggregation Pathways, Kinetics, and Thermodynamics; CHAPTER 3: Identification and Impact of Aggregation-Prone Regions in Proteins and Therapeutic Monoclonal Antibodies; CHAPTER 4: External Factors Affecting Protein Aggregation; CHAPTER 5: Experimental Detection and Characterization of Protein Aggregates; CHAPTER 6: Approaches to Control Protein Aggregation during Bulk Production
CHAPTER 7: Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces, and Drug Product Manufacturing OperationsCHAPTER 8: Approaches to Managing Protein Aggregation in Product Development; CHAPTER 9: Case Studies Involving Protein Aggregation; CHAPTER 10: Aggregation and Immunogenicity of Therapeutic Proteins; CHAPTER 11: Regulatory Perspective on Aggregates as a Product Quality Attribute; INDEX; color plate |
| Record Nr. | UNINA-9910140832103321 |
| Hoboken, NJ, : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Aggregation of therapeutic proteins / / edited by Wei Wang, Christopher J. Roberts
| Aggregation of therapeutic proteins / / edited by Wei Wang, Christopher J. Roberts |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, NJ, : Wiley, c2010 |
| Descrizione fisica | 1 online resource (514 p.) |
| Disciplina | 615.5/8 |
| Altri autori (Persone) |
WangWei <1957 Mar. 10->
RobertsChristopher John <1972-> |
| Soggetto topico |
Protein drugs
Aggregation (Chemistry) |
| ISBN |
9786612707988
9781118043585 1118043588 9781282707986 1282707981 9780470769829 0470769823 9780470769812 0470769815 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
AGGREGATION OF THERAPEUTIC PROTEINS; CONTENTS; PREFACE; CONTRIBUTORS; CHAPTER 1: Fundamental Structures and Behaviors of Proteins; CHAPTER 2: Protein Aggregation Pathways, Kinetics, and Thermodynamics; CHAPTER 3: Identification and Impact of Aggregation-Prone Regions in Proteins and Therapeutic Monoclonal Antibodies; CHAPTER 4: External Factors Affecting Protein Aggregation; CHAPTER 5: Experimental Detection and Characterization of Protein Aggregates; CHAPTER 6: Approaches to Control Protein Aggregation during Bulk Production
CHAPTER 7: Protein Aggregation and Particle Formation: Effects of Formulation, Interfaces, and Drug Product Manufacturing OperationsCHAPTER 8: Approaches to Managing Protein Aggregation in Product Development; CHAPTER 9: Case Studies Involving Protein Aggregation; CHAPTER 10: Aggregation and Immunogenicity of Therapeutic Proteins; CHAPTER 11: Regulatory Perspective on Aggregates as a Product Quality Attribute; INDEX; color plate |
| Record Nr. | UNINA-9910819845003321 |
| Hoboken, NJ, : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Clinical therapeutics
| Clinical therapeutics |
| Pubbl/distr/stampa | [Princeton, N.J.], : Excerpta Medica |
| Disciplina | 615.5/8 |
| Soggetto topico |
Chemotherapy
Chemotherapy - Periodicals Chimiothérapie - Périodiques Chimiothérapie |
| Soggetto genere / forma | Periodicals. |
| ISSN | 1879-114X |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNISA-996209481803316 |
| [Princeton, N.J.], : Excerpta Medica | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. di Salerno | ||
| ||
Clinical therapeutics
| Clinical therapeutics |
| Pubbl/distr/stampa | [Princeton, N.J.], : Excerpta Medica |
| Disciplina | 615.5/8 |
| Soggetto topico |
Chemotherapy
Chimiothérapie - Périodiques Chimiothérapie |
| Soggetto genere / forma | Periodicals. |
| ISSN | 1879-114X |
| Formato | Materiale a stampa |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910145205503321 |
| [Princeton, N.J.], : Excerpta Medica | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of new MDR-tuberculosis drugs [[electronic resource] /] / Jarmila Vinšová and Martin Krátký
| Development of new MDR-tuberculosis drugs [[electronic resource] /] / Jarmila Vinšová and Martin Krátký |
| Autore | Vinšová Jarmila |
| Pubbl/distr/stampa | New York, : Nova Science Publishers/Nova Biomedical, c2010 |
| Descrizione fisica | 1 online resource (112 p.) |
| Disciplina | 615.5/8 |
| Altri autori (Persone) | KrátkýMartin <1960-> |
| Collana | Pharmacology-research, safety testing and regulation |
| Soggetto topico |
Antitubercular agents
Multidrug-resistant tuberculosis - Chemotherapy |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-61668-478-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Resistance to commonly used drugs, mechanism of the action -- Research of novel MDR potential drugs. |
| Record Nr. | UNINA-9910465691303321 |
Vinšová Jarmila
|
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| New York, : Nova Science Publishers/Nova Biomedical, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of new MDR-tuberculosis drugs [[electronic resource] /] / Jarmila Vinšová and Martin Krátký
| Development of new MDR-tuberculosis drugs [[electronic resource] /] / Jarmila Vinšová and Martin Krátký |
| Autore | Vinšová Jarmila |
| Pubbl/distr/stampa | New York, : Nova Science Publishers/Nova Biomedical, c2010 |
| Descrizione fisica | 1 online resource (112 p.) |
| Disciplina | 615.5/8 |
| Altri autori (Persone) | KrátkýMartin <1960-> |
| Collana | Pharmacology-research, safety testing and regulation |
| Soggetto topico |
Antitubercular agents
Multidrug-resistant tuberculosis - Chemotherapy |
| ISBN | 1-61668-478-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Resistance to commonly used drugs, mechanism of the action -- Research of novel MDR potential drugs. |
| Record Nr. | UNINA-9910791768103321 |
|
Vinšová Jarmila
|
||
| New York, : Nova Science Publishers/Nova Biomedical, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Development of new MDR-tuberculosis drugs / / Jarmila Vinšová and Martin Krátký
| Development of new MDR-tuberculosis drugs / / Jarmila Vinšová and Martin Krátký |
| Autore | Vinšová Jarmila |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | New York, : Nova Science Publishers/Nova Biomedical, c2010 |
| Descrizione fisica | 1 online resource (112 p.) |
| Disciplina | 615.5/8 |
| Altri autori (Persone) | KrátkýMartin <1960-> |
| Collana | Pharmacology-research, safety testing and regulation |
| Soggetto topico |
Antitubercular agents
Multidrug-resistant tuberculosis - Chemotherapy |
| ISBN | 1-61668-478-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Resistance to commonly used drugs, mechanism of the action -- Research of novel MDR potential drugs. |
| Record Nr. | UNINA-9910967797203321 |
|
Vinšová Jarmila
|
||
| New York, : Nova Science Publishers/Nova Biomedical, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Extracorporeal photopheresis [[electronic resource] ] : cellular photoimmunotherapy / / edited by Hildegard Greinix and Robert Knobler
| Extracorporeal photopheresis [[electronic resource] ] : cellular photoimmunotherapy / / edited by Hildegard Greinix and Robert Knobler |
| Pubbl/distr/stampa | Berlin ; ; Boston, : De Gruyter, c2012 |
| Descrizione fisica | 1 online resource (228 p.) |
| Disciplina |
615.5/8
615.831 |
| Altri autori (Persone) |
GreinixHildegard T
KnoblerRobert |
| Soggetto topico |
Photochemotherapy
Cancer - Treatment |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-283-85672-7
3-11-027613-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front matter -- Preface -- Content -- Authors Index -- Section 1: History of Extracorporeal Photopheresis / Knobler, Robert -- Section 2: Technical Aspects / Jacobsohn, David / Wong, Edward / Worel, Nina / Hölig, Kristina / Bohbot, Alain / Liu, Vincent / Lioure, Bruno / Bilger, Karin / Laplace, Annegret / Herbrecht, Raoul -- Section 3: Mechanisms of Action of ECP / Ferrara, James LM / Schwarz, Thomas / Gatza, Erin / Taylor, Peter C. / Whittle, Rob M. -- Section 4: Extracorporeal Photopheresis in Acute Graft-versus-Host Disease / Greinix, Hildegard T. / Bacigalupo, Andrea -- Section 5: Extracorporeal Photopheresis in Chronic Graft-versus-Host Disease / Flowers, Mary E.D. / Inamoto, Yoshiro / Jagasia, Madan / Raj, Kavita / Das-Gupta, Emma / Couriel, Daniel / Zureki, Kari / Greinix, Hildegard T. -- Section 6: ECP for the Prevention of Graft-versus-Host Disease / Levine, John E. / Kitko, Carrie -- Section 7: ECP in Cutaneous T Cell Lymphoma / Scarisbrick, Julia -- Section 8: ECP in Scleroderma and Other Skin Diseases / Just, Ulrike -- Section 9: ECP in Crohn's Disease / Reinisch, Walter -- Section 10: Extracorporeal Photopheresis after Solid Organ/Tissue Transplantation / Zic, John A. / Michallet, Mauricette / Sobh, Mohamad -- Section 11: ECP in Diabetes Mellitus / Berlin, Gösta / Ludvigsson, Johnny -- Section 12: Side Effects of Extracorporeal Photopheresis / Hillen, Uwe -- Section 13: Summary / Greinix, Hildegard T. |
| Record Nr. | UNINA-9910462981703321 |
| Berlin ; ; Boston, : De Gruyter, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Extracorporeal photopheresis [[electronic resource] ] : cellular photoimmunotherapy / / edited by Hildegard Greinix and Robert Knobler
| Extracorporeal photopheresis [[electronic resource] ] : cellular photoimmunotherapy / / edited by Hildegard Greinix and Robert Knobler |
| Pubbl/distr/stampa | Berlin ; ; Boston, : De Gruyter, c2012 |
| Descrizione fisica | 1 online resource (228 p.) |
| Disciplina |
615.5/8
615.831 |
| Altri autori (Persone) |
GreinixHildegard T
KnoblerRobert |
| Soggetto topico |
Photochemotherapy
Cancer - Treatment |
| ISBN |
1-283-85672-7
3-11-027613-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front matter -- Preface -- Content -- Authors Index -- Section 1: History of Extracorporeal Photopheresis / Knobler, Robert -- Section 2: Technical Aspects / Jacobsohn, David / Wong, Edward / Worel, Nina / Hölig, Kristina / Bohbot, Alain / Liu, Vincent / Lioure, Bruno / Bilger, Karin / Laplace, Annegret / Herbrecht, Raoul -- Section 3: Mechanisms of Action of ECP / Ferrara, James LM / Schwarz, Thomas / Gatza, Erin / Taylor, Peter C. / Whittle, Rob M. -- Section 4: Extracorporeal Photopheresis in Acute Graft-versus-Host Disease / Greinix, Hildegard T. / Bacigalupo, Andrea -- Section 5: Extracorporeal Photopheresis in Chronic Graft-versus-Host Disease / Flowers, Mary E.D. / Inamoto, Yoshiro / Jagasia, Madan / Raj, Kavita / Das-Gupta, Emma / Couriel, Daniel / Zureki, Kari / Greinix, Hildegard T. -- Section 6: ECP for the Prevention of Graft-versus-Host Disease / Levine, John E. / Kitko, Carrie -- Section 7: ECP in Cutaneous T Cell Lymphoma / Scarisbrick, Julia -- Section 8: ECP in Scleroderma and Other Skin Diseases / Just, Ulrike -- Section 9: ECP in Crohn's Disease / Reinisch, Walter -- Section 10: Extracorporeal Photopheresis after Solid Organ/Tissue Transplantation / Zic, John A. / Michallet, Mauricette / Sobh, Mohamad -- Section 11: ECP in Diabetes Mellitus / Berlin, Gösta / Ludvigsson, Johnny -- Section 12: Side Effects of Extracorporeal Photopheresis / Hillen, Uwe -- Section 13: Summary / Greinix, Hildegard T. |
| Record Nr. | UNINA-9910786435603321 |
| Berlin ; ; Boston, : De Gruyter, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
A history of a cGMP medical event investigation / / Michael A. Brown
| A history of a cGMP medical event investigation / / Michael A. Brown |
| Autore | Brown Michael A. <1945-> |
| Pubbl/distr/stampa | Hoboken, N.J., : J. Wiley & Sons, c2013 |
| Descrizione fisica | 1 online resource (251 p.) |
| Disciplina | 615.5/8 |
| Soggetto topico | Drugs - Side effects - Reporting - United States |
| ISBN |
9781118494943
1118494946 9781283917537 128391753X 9781118494936 1118494938 9781118494882 1118494881 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Title page; Copyright page; Dedication; Contents; Preface; ***; PART ONE: The Event; 1: Francesca; ***; PART TWO: Drug Discovery:Five Years Earlier; 2: Katlin BioScience: Transgenic Mouse Study; 3: Oxy-Fox Inhaler; 3.1 Kinnen Laboratories; 3.2 Kinnen Laboratories: Oxy-Fox Transfer; 3.3 Due-Diligence Team and Katlin Data Acceptance; PART THREE: Kinnen Oxy-Fox Inhaler Market Launch Program; 4: Agency IND and NDA Requirements, Six Sigma Charter, and Device Master Record; 4.1 Launch Team Meeting Number 1; ***; ***; ***; 4.2 Meeting with Medical Affairs: Toxicity Studies
5: Meeting Minutes Guidelines5.1 Launch Team Meeting Number 2; ***; 6: Project Timing, Marketing Plan, and Offshore Molding; 6.1 Launch Team Meeting Number 3; 6.2 Project Financial Review; 6.3 Progress Meeting: Who Takes Credit for What?; 6.4 Morning meeting: Just-in-Time Manufacturing; 7: cGMP Process Validation Requirements; 7.1 Launch Team Meeting Number 4; ***; 8: Failure Mode Effects Analysis; 8.1 Launch Team Meeting Number 5; ***; 9: Design for Manufacturability, Design for Six Sigma, Concurrent Design; 9.1 Product Development Meeting Number 1; *** 9.2 Update Meeting with Ed Chase and Gordon Taylor10: Design Fishbone Diagram; 10.1 Launch Team Meeting Number 6; 11: Product Specifications; 11.1 Product Development Meeting Number 2; 12: Design Control; 12.1 Design Team Meeting Number 7; 12.2 Product Development Staff Meeting; 12.3 Engineering One-on-One; 12.4 Program Update; 13: Design of Experiments (DOE); 13.1 Molding Team Meeting; 14: Start-Up Issues; 14.1 Oxy-Fox Inhaler Wrap-Up and Equipment Start-Up; ***; 14.2 The Final Management Review; ***; PART FOUR: Present Day: Funeral; 15: Grief; ***; 16: The Autopsy Results; *** 17: The Agency***; ***; PART FIVE: Agency Medical Event Letter; 18: Kinnen Notification; 18.1 Another Agency Letter; 18.2 Medical Event Review Meeting; ***; 19: Investigation Team Management; 19.1. Morning Meeting with Gail Strom, Marcia Hines, and Dan Garvey; 20: DMAIC Investigation Process; 21: Internal Quality Review; 21.1 Meeting with Gail Strom and Marcia Hines; 21.2 Executive Management Review; ***; ***; ***; 22: The Agency Audit Letter; ***; 23: Agency Arrival; ***; 24: The Audit 24.1 Agency Meeting to Review Qualification Documents and the Quality Acceptance Records of First Lot to Stock***; 24.2 Agency Meeting to Review the Oxy-Fox Inhaler Lot Used in the NDA Clinical Studies; 24.3 Agency Meeting to Review the Design and Program Team Meeting Minutes; ***; 24.4 Agency Meeting to Review the Due-Diligence Report, Katlin Studies, and Oxy-Fox Design History File; ***; 25: End-of-Day Agency Wrap-Up Meeting; ***; 26: Kinnen Management Review; ***; ***; PART SIX: Reckoning; 27: Blame and Responsibility; 27.1 The Investigation Is a Public Record; 27.2 Kinnen Wrap-Up; *** 28: Closure |
| Record Nr. | UNINA-9911020240703321 |
|
Brown Michael A. <1945->
|
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| Hoboken, N.J., : J. Wiley & Sons, c2013 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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