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Absorption and drug development : solubility, permeability, and charge state / / Alex Avdeef
| Absorption and drug development : solubility, permeability, and charge state / / Alex Avdeef |
| Autore | Avdeef Alex |
| Edizione | [2nd ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2012 |
| Descrizione fisica | 1 online resource (742 p.) |
| Disciplina | 615/.19 |
| Soggetto topico |
Drugs - Design
Drugs - Metabolism Drug development Absorption |
| ISBN |
1-62198-226-2
1-280-58934-5 9786613619174 1-118-28603-0 1-118-28606-5 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Introduction -- Transport model -- pKa determination -- Octanol-water partitioning -- Liposome-water partitioning -- Solubility -- Permeability - Pampa -- Permeability Caco 2/MDCK -- Permeability blood brain barrier. |
| Record Nr. | UNINA-9910141449403321 |
Avdeef Alex
|
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| Hoboken, N.J., : John Wiley & Sons, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
ADME-enabling technologies for drug design and development [[electronic resource] /] / edited by Donglu Zhang, Sekhar Surapaneni
| ADME-enabling technologies for drug design and development [[electronic resource] /] / edited by Donglu Zhang, Sekhar Surapaneni |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2012 |
| Descrizione fisica | 1 online resource (623 p.) |
| Disciplina | 615.1/9 |
| Altri autori (Persone) |
ZhangDonglu
SurapaneniSekhar |
| Soggetto topico |
Drugs - Design
Drug development Drugs - Metabolism Pharmaceutical chemistry Pharmacokinetics Pharmaceutical technology |
| ISBN |
1-280-59257-5
9786613622402 1-118-18076-3 1-118-18077-1 1-118-18074-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
ADME-Enabling Technologies in Drug Design and Development; CONTENTS; FOREWORD; PREFACE; CONTRIBUTORS; PART A: ADME: OVERVIEW AND CURRENT TOPICS; 1: REGULATORY DRUG DISPOSITION AND NDA PACKAGE INCLUDING MIST; 1.1 INTRODUCTION; 1.2 NONCLINICAL OVERVIEW; 1.3 PK; 1.4 ABSORPTION; 1.5 DISTRIBUTION; 1.5.1 Plasma Protein Binding; 1.5.2 Tissue Distribution; 1.5.3 Lacteal and Placental Distribution Studies; 1.6 METABOLISM; 1.6.1 In vitro Metabolism Studies; 1.6.2 Drug-Drug Interaction Studies; 1.6.3 In vivo Metabolism (ADME) Studies; 1.7 EXCRETION; 1.8 IMPACT OF METABOLISM INFORMATION ON LABELING
1.9 CONCLUSIONSREFERENCES; 2: OPTIMAL ADME PROPERTIES FOR CLINICAL CANDIDATE AND INVESTIGATIONAL NEW DRUG (IND) PACKAGE; 2.1 INTRODUCTION; 2.2 NCE AND INVESTIGATIONAL NEW DRUG (IND) PACKAGE; 2.3 ADME OPTIMIZATION; 2.3.1 Absorption; 2.3.2 Metabolism; 2.3.3 PK; 2.4 ADME OPTIMIZATION FOR CNS DRUGS; 2.5 SUMMARY; REFERENCES; 3: DRUG TRANSPORTERS IN DRUG INTERACTIONS AND DISPOSITION; 3.1 INTRODUCTION; 3.2 ABC TRANSPORTERS; 3.2.1 Pgp (MDR1, ABCB1); 3.2.2 BCRP (ABCG2); 3.2.3 MRP2 (ABCC2); 3.3 SLC TRANSPORTERS; 3.3.1 OCT1 (SLC22A1) and OCT2 (SLC22A2); 3.3.2 MATE1 (SLC47A1) and MATE2K (SLC47A2) 3.3.3 OAT1 (SLC22A6) and OAT3 (SLC22A8)3.3.4 OATP1B1 (SLCO1B1, SLC21A6), OATP1B3 (SLCO1B3, SLC21A8), and OATP2B1 (SLCO2B1, SLC21A9); 3.4 IN VITRO ASSAYS IN DRUG DEVELOPMENT; 3.4.1 Considerations for Assessing Candidate Drugs as Inhibitors; 3.4.2 Considerations for Assessing Candidate Drugs as Substrates; 3.4.3 Assay Systems; 3.5 CONCLUSIONS AND PERSPECTIVES; REFERENCES; 4: PHARMACOLOGICAL AND TOXICOLOGICAL ACTIVITY OF DRUG METABOLITES; 4.1 INTRODUCTION; 4.2 ASSESSMENT OF POTENTIAL FOR ACTIVE METABOLITES; 4.2.1 Detection of Active Metabolites during Drug Discovery 4.2.2 Methods for Assessing and Evaluating the Biological Activity of Metabolite Mixtures4.2.3 Methods for Generation of Metabolites; 4.3 ASSESSMENT OF THE POTENTIAL TOXICOLOGY OF METABOLITES; 4.3.1 Methods to Study the Formation of Reactive Metabolites; 4.3.2 Reactive Metabolite Studies: In vitro; 4.3.3 Reactive Metabolite Studies: In vivo; 4.3.4 Reactive Metabolite Data Interpretation; 4.3.5 Metabolite Contribution to Off-Target Toxicities; 4.4 SAFETY TESTING OF DRUG METABOLITES; 4.5 SUMMARY; REFERENCES 5: IMPROVING THE PHARMACEUTICAL PROPERTIES OF BIOLOGICS IN DRUG DISCOVERY: UNIQUE CHALLENGES AND ENABLING SOLUTIONS5.1 INTRODUCTION; 5.2 PHARMACOKINETICS; 5.3 METABOLISM AND DISPOSITION; 5.4 IMMUNOGENICITY; 5.5 TOXICITY AND PRECLINICAL ASSESSMENT; 5.6 COMPARABILITY; 5.7 CONCLUSIONS; REFERENCES; 6: CLINICAL DOSE ESTIMATION USING PHARMACOKINETIC/PHARMACODYNAMIC MODELING AND SIMULATION; 6.1 INTRODUCTION; 6.2 BIOMARKERS IN PK AND PD; 6.2.1 PK; 6.2.2 PD; 6.2.3 Biomarkers; 6.3 MODEL-BASED CLINICAL DRUG DEVELOPMENT; 6.3.1 Modeling; 6.3.2 Simulation; 6.3.3 Population Modeling 6.3.4 Quantitative Pharmacology (QP) and Pharmacometrics |
| Record Nr. | UNINA-9910141254203321 |
| Hoboken, N.J., : Wiley, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
ADME-enabling technologies for drug design and development / / edited by Donglu Zhang, Sekhar Surapaneni
| ADME-enabling technologies for drug design and development / / edited by Donglu Zhang, Sekhar Surapaneni |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2012 |
| Descrizione fisica | 1 online resource (623 p.) |
| Disciplina | 615.1/9 |
| Altri autori (Persone) |
ZhangDonglu
SurapaneniSekhar |
| Soggetto topico |
Drugs - Design
Drug development Drugs - Metabolism Pharmaceutical chemistry Pharmacokinetics Pharmaceutical technology |
| ISBN |
1-280-59257-5
9786613622402 1-118-18076-3 1-118-18077-1 1-118-18074-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
ADME-Enabling Technologies in Drug Design and Development; CONTENTS; FOREWORD; PREFACE; CONTRIBUTORS; PART A: ADME: OVERVIEW AND CURRENT TOPICS; 1: REGULATORY DRUG DISPOSITION AND NDA PACKAGE INCLUDING MIST; 1.1 INTRODUCTION; 1.2 NONCLINICAL OVERVIEW; 1.3 PK; 1.4 ABSORPTION; 1.5 DISTRIBUTION; 1.5.1 Plasma Protein Binding; 1.5.2 Tissue Distribution; 1.5.3 Lacteal and Placental Distribution Studies; 1.6 METABOLISM; 1.6.1 In vitro Metabolism Studies; 1.6.2 Drug-Drug Interaction Studies; 1.6.3 In vivo Metabolism (ADME) Studies; 1.7 EXCRETION; 1.8 IMPACT OF METABOLISM INFORMATION ON LABELING
1.9 CONCLUSIONSREFERENCES; 2: OPTIMAL ADME PROPERTIES FOR CLINICAL CANDIDATE AND INVESTIGATIONAL NEW DRUG (IND) PACKAGE; 2.1 INTRODUCTION; 2.2 NCE AND INVESTIGATIONAL NEW DRUG (IND) PACKAGE; 2.3 ADME OPTIMIZATION; 2.3.1 Absorption; 2.3.2 Metabolism; 2.3.3 PK; 2.4 ADME OPTIMIZATION FOR CNS DRUGS; 2.5 SUMMARY; REFERENCES; 3: DRUG TRANSPORTERS IN DRUG INTERACTIONS AND DISPOSITION; 3.1 INTRODUCTION; 3.2 ABC TRANSPORTERS; 3.2.1 Pgp (MDR1, ABCB1); 3.2.2 BCRP (ABCG2); 3.2.3 MRP2 (ABCC2); 3.3 SLC TRANSPORTERS; 3.3.1 OCT1 (SLC22A1) and OCT2 (SLC22A2); 3.3.2 MATE1 (SLC47A1) and MATE2K (SLC47A2) 3.3.3 OAT1 (SLC22A6) and OAT3 (SLC22A8)3.3.4 OATP1B1 (SLCO1B1, SLC21A6), OATP1B3 (SLCO1B3, SLC21A8), and OATP2B1 (SLCO2B1, SLC21A9); 3.4 IN VITRO ASSAYS IN DRUG DEVELOPMENT; 3.4.1 Considerations for Assessing Candidate Drugs as Inhibitors; 3.4.2 Considerations for Assessing Candidate Drugs as Substrates; 3.4.3 Assay Systems; 3.5 CONCLUSIONS AND PERSPECTIVES; REFERENCES; 4: PHARMACOLOGICAL AND TOXICOLOGICAL ACTIVITY OF DRUG METABOLITES; 4.1 INTRODUCTION; 4.2 ASSESSMENT OF POTENTIAL FOR ACTIVE METABOLITES; 4.2.1 Detection of Active Metabolites during Drug Discovery 4.2.2 Methods for Assessing and Evaluating the Biological Activity of Metabolite Mixtures4.2.3 Methods for Generation of Metabolites; 4.3 ASSESSMENT OF THE POTENTIAL TOXICOLOGY OF METABOLITES; 4.3.1 Methods to Study the Formation of Reactive Metabolites; 4.3.2 Reactive Metabolite Studies: In vitro; 4.3.3 Reactive Metabolite Studies: In vivo; 4.3.4 Reactive Metabolite Data Interpretation; 4.3.5 Metabolite Contribution to Off-Target Toxicities; 4.4 SAFETY TESTING OF DRUG METABOLITES; 4.5 SUMMARY; REFERENCES 5: IMPROVING THE PHARMACEUTICAL PROPERTIES OF BIOLOGICS IN DRUG DISCOVERY: UNIQUE CHALLENGES AND ENABLING SOLUTIONS5.1 INTRODUCTION; 5.2 PHARMACOKINETICS; 5.3 METABOLISM AND DISPOSITION; 5.4 IMMUNOGENICITY; 5.5 TOXICITY AND PRECLINICAL ASSESSMENT; 5.6 COMPARABILITY; 5.7 CONCLUSIONS; REFERENCES; 6: CLINICAL DOSE ESTIMATION USING PHARMACOKINETIC/PHARMACODYNAMIC MODELING AND SIMULATION; 6.1 INTRODUCTION; 6.2 BIOMARKERS IN PK AND PD; 6.2.1 PK; 6.2.2 PD; 6.2.3 Biomarkers; 6.3 MODEL-BASED CLINICAL DRUG DEVELOPMENT; 6.3.1 Modeling; 6.3.2 Simulation; 6.3.3 Population Modeling 6.3.4 Quantitative Pharmacology (QP) and Pharmacometrics |
| Record Nr. | UNINA-9910816078003321 |
| Hoboken, N.J., : Wiley, c2012 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advanced vaccine research : methods for the decade of vaccines / / edited by Fabio Bagnoli and Rino Rappuoli
| Advanced vaccine research : methods for the decade of vaccines / / edited by Fabio Bagnoli and Rino Rappuoli |
| Pubbl/distr/stampa | Norfolk, England : , : Caister Academic Press, , [2015] |
| Descrizione fisica | 1 online resource (474 p.) |
| Disciplina | 615.372 |
| Soggetto topico |
Vaccines - Research
Drug development |
| Soggetto genere / forma | Electronic books. |
| ISBN | 1-910190-04-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; Contributors; Current Books of Interest; Preface; Part I: Innovative Technologies and Approaches in Vaccine Research; 1: Deep Sequencing in Vaccine Research, Development and Surveillance ; Impact of DNA sequencing on vaccines research and development; Deep sequencing potential to transform vaccinology; 2: New Bioinformatics Algorithms Applied to Deep Sequencing Projects ; Introduction; Better understating of host and pathogen genomes; Computational approaches to study adaptive immune responses; Better understanding of transcriptome
Epigenomics: understanding of inheritable chemical changesMetagenomics: finding new pathogens and strains; Bioinformatics challenges; 3: Comparative Genomics Approaches for Tracking the Emergence and Spread of Disease-associated Bacteria; Background; Comparative genomics of disease-associated bacteria; Assays for identification of disease-associated bacteria based on insights from comparative genomics; Conclusions; 4: Quantitative Proteomics in Vaccine Research; Introduction; Quantitative proteomics based on gel electrophoresis; Quantitative proteomics based on differential mass tag Label-free technologies and targeted proteomicsMass spectrometry for viral vaccinology; Proteomic technology for vaccine development ; Combining proteomics and system biology to improve vaccines; Concluding remarks; 5: Structural Biology in Vaccine Research; Introduction; Experimental mapping and computational prediction of epitopes; Examples of structural vaccinology for bacterial and viral pathogens; Concluding remarks and future directions; 6: Cellular Screens to Interrogate the Human T- and B-cell Repertoires and Design Better Vaccines ; Introduction Generation of naive B- and T-cell repertoires7: Novel Strategies of Vaccine Administration: The Science Behind Epidermal and Dermal Immunization; Introduction; The skin layers; Skin antigen-presenting cells and other players in vaccination; Principles and methods in skin immunization; Vaccine formulation and immunity; Immunological advantage of epidermal and dermal immunization; 8: Toll-like Receptors as Targets to Develop Novel Adjuvants; Introduction; Innate immunity; TLR-based adjuvants in high-priority vaccines; Lessons learned from studies of TLR agonists as adjuvants Safety considerations of TLR agonistsChallenges for the next decade; 9: The Importance of Cell-mediated Immunity for Bacterial Vaccines ; Introduction; T-cell responses to bacterial infection; Targeting cellular immunity for novel anti-bacterial vaccine design; 10: T-cell-inducing Vaccines; Introduction; How can we measure T-cell responses?; Technologies for inducing T-cell responses by vaccination; Heterologous prime-boost immunization; Successful clinical development of T-cell vaccines; 11: Exploiting the Mutanome for Personalized Cancer Immunotherapy Cancer mutations as therapeutic targets |
| Record Nr. | UNINA-9910460918103321 |
| Norfolk, England : , : Caister Academic Press, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advanced vaccine research : methods for the decade of vaccines / / edited by Fabio Bagnoli and Rino Rappuoli
| Advanced vaccine research : methods for the decade of vaccines / / edited by Fabio Bagnoli and Rino Rappuoli |
| Pubbl/distr/stampa | Norfolk, England : , : Caister Academic Press, , [2015] |
| Descrizione fisica | 1 online resource (474 p.) |
| Disciplina | 615.372 |
| Soggetto topico |
Vaccines - Research
Drug development |
| ISBN | 1-910190-04-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; Contributors; Current Books of Interest; Preface; Part I: Innovative Technologies and Approaches in Vaccine Research; 1: Deep Sequencing in Vaccine Research, Development and Surveillance ; Impact of DNA sequencing on vaccines research and development; Deep sequencing potential to transform vaccinology; 2: New Bioinformatics Algorithms Applied to Deep Sequencing Projects ; Introduction; Better understating of host and pathogen genomes; Computational approaches to study adaptive immune responses; Better understanding of transcriptome
Epigenomics: understanding of inheritable chemical changesMetagenomics: finding new pathogens and strains; Bioinformatics challenges; 3: Comparative Genomics Approaches for Tracking the Emergence and Spread of Disease-associated Bacteria; Background; Comparative genomics of disease-associated bacteria; Assays for identification of disease-associated bacteria based on insights from comparative genomics; Conclusions; 4: Quantitative Proteomics in Vaccine Research; Introduction; Quantitative proteomics based on gel electrophoresis; Quantitative proteomics based on differential mass tag Label-free technologies and targeted proteomicsMass spectrometry for viral vaccinology; Proteomic technology for vaccine development ; Combining proteomics and system biology to improve vaccines; Concluding remarks; 5: Structural Biology in Vaccine Research; Introduction; Experimental mapping and computational prediction of epitopes; Examples of structural vaccinology for bacterial and viral pathogens; Concluding remarks and future directions; 6: Cellular Screens to Interrogate the Human T- and B-cell Repertoires and Design Better Vaccines ; Introduction Generation of naive B- and T-cell repertoires7: Novel Strategies of Vaccine Administration: The Science Behind Epidermal and Dermal Immunization; Introduction; The skin layers; Skin antigen-presenting cells and other players in vaccination; Principles and methods in skin immunization; Vaccine formulation and immunity; Immunological advantage of epidermal and dermal immunization; 8: Toll-like Receptors as Targets to Develop Novel Adjuvants; Introduction; Innate immunity; TLR-based adjuvants in high-priority vaccines; Lessons learned from studies of TLR agonists as adjuvants Safety considerations of TLR agonistsChallenges for the next decade; 9: The Importance of Cell-mediated Immunity for Bacterial Vaccines ; Introduction; T-cell responses to bacterial infection; Targeting cellular immunity for novel anti-bacterial vaccine design; 10: T-cell-inducing Vaccines; Introduction; How can we measure T-cell responses?; Technologies for inducing T-cell responses by vaccination; Heterologous prime-boost immunization; Successful clinical development of T-cell vaccines; 11: Exploiting the Mutanome for Personalized Cancer Immunotherapy Cancer mutations as therapeutic targets |
| Record Nr. | UNINA-9910787429503321 |
| Norfolk, England : , : Caister Academic Press, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advanced vaccine research : methods for the decade of vaccines / / edited by Fabio Bagnoli and Rino Rappuoli
| Advanced vaccine research : methods for the decade of vaccines / / edited by Fabio Bagnoli and Rino Rappuoli |
| Pubbl/distr/stampa | Norfolk, England : , : Caister Academic Press, , [2015] |
| Descrizione fisica | 1 online resource (474 p.) |
| Disciplina | 615.372 |
| Soggetto topico |
Vaccines - Research
Drug development |
| ISBN | 1-910190-04-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Contents; Contributors; Current Books of Interest; Preface; Part I: Innovative Technologies and Approaches in Vaccine Research; 1: Deep Sequencing in Vaccine Research, Development and Surveillance ; Impact of DNA sequencing on vaccines research and development; Deep sequencing potential to transform vaccinology; 2: New Bioinformatics Algorithms Applied to Deep Sequencing Projects ; Introduction; Better understating of host and pathogen genomes; Computational approaches to study adaptive immune responses; Better understanding of transcriptome
Epigenomics: understanding of inheritable chemical changesMetagenomics: finding new pathogens and strains; Bioinformatics challenges; 3: Comparative Genomics Approaches for Tracking the Emergence and Spread of Disease-associated Bacteria; Background; Comparative genomics of disease-associated bacteria; Assays for identification of disease-associated bacteria based on insights from comparative genomics; Conclusions; 4: Quantitative Proteomics in Vaccine Research; Introduction; Quantitative proteomics based on gel electrophoresis; Quantitative proteomics based on differential mass tag Label-free technologies and targeted proteomicsMass spectrometry for viral vaccinology; Proteomic technology for vaccine development ; Combining proteomics and system biology to improve vaccines; Concluding remarks; 5: Structural Biology in Vaccine Research; Introduction; Experimental mapping and computational prediction of epitopes; Examples of structural vaccinology for bacterial and viral pathogens; Concluding remarks and future directions; 6: Cellular Screens to Interrogate the Human T- and B-cell Repertoires and Design Better Vaccines ; Introduction Generation of naive B- and T-cell repertoires7: Novel Strategies of Vaccine Administration: The Science Behind Epidermal and Dermal Immunization; Introduction; The skin layers; Skin antigen-presenting cells and other players in vaccination; Principles and methods in skin immunization; Vaccine formulation and immunity; Immunological advantage of epidermal and dermal immunization; 8: Toll-like Receptors as Targets to Develop Novel Adjuvants; Introduction; Innate immunity; TLR-based adjuvants in high-priority vaccines; Lessons learned from studies of TLR agonists as adjuvants Safety considerations of TLR agonistsChallenges for the next decade; 9: The Importance of Cell-mediated Immunity for Bacterial Vaccines ; Introduction; T-cell responses to bacterial infection; Targeting cellular immunity for novel anti-bacterial vaccine design; 10: T-cell-inducing Vaccines; Introduction; How can we measure T-cell responses?; Technologies for inducing T-cell responses by vaccination; Heterologous prime-boost immunization; Successful clinical development of T-cell vaccines; 11: Exploiting the Mutanome for Personalized Cancer Immunotherapy Cancer mutations as therapeutic targets |
| Record Nr. | UNINA-9910820979003321 |
| Norfolk, England : , : Caister Academic Press, , [2015] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors
| Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2014 |
| Descrizione fisica | 1 online resource (90 pages) : illustrations (some color) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Testing
Drug development |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-909453-27-7
1-909453-28-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910464757503321 |
| London, England : , : Future Science Ltd, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors
| Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2014 |
| Descrizione fisica | 1 online resource (90 pages) : illustrations (some color) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Testing
Drug development |
| ISBN |
1-909453-27-7
1-909453-28-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910789329703321 |
| London, England : , : Future Science Ltd, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors
| Advances in collating and using trial data / / Sylvie Chevret, Matthieu Resche-Rigon, editors |
| Pubbl/distr/stampa | London, England : , : Future Science Ltd, , 2014 |
| Descrizione fisica | 1 online resource (90 pages) : illustrations (some color) |
| Disciplina | 615.1901 |
| Soggetto topico |
Drugs - Testing
Drug development |
| ISBN |
1-909453-27-7
1-909453-28-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910821759403321 |
| London, England : , : Future Science Ltd, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
The agile approach to adaptive research [[electronic resource] ] : optimizing efficiency in clinical development / / Michael J. Rosenberg
| The agile approach to adaptive research [[electronic resource] ] : optimizing efficiency in clinical development / / Michael J. Rosenberg |
| Autore | Rosenberg Michael J |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (296 p.) |
| Disciplina | 615/.19 |
| Collana | Wiley series on technologies for the pharmaceutical industry |
| Soggetto topico |
Drug development
Pharmaceutical industry |
| ISBN |
1-282-54764-X
9786612547645 0-470-59968-5 0-470-59967-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
The Agile Approach to Adaptive Research: Optimizing Efficiency in Clinical Development; Contents; Preface; Acknowledgments; 1 Opportunity for Efficiency; The Adaptive Solution; An Industrial Success Story; Signs of Trouble Ahead; Converging Challenges; The Struggle to Replace Lost Revenues; Clinical Research Is the Key; Behind the High Costs of Clinical Development; High Costs and Increasing Prices; Growing Pressures Mandate Greater Efficiency; The High Risk of Current Development Practices; Economic Consequences of Faster Clinical Development; Thriving in a New Era; References
2 Defining and Extending the Adaptive ApproachThe Adaptive Concept; Knowledge, Time, and Decision Making; The Value of Early Knowledge; The Spectrum of Design and Operational Adaptations; Maximizing the Adaptive Approach: Agile Clinical Development; Measure Performance in Real Time; Metrics in Action; Right Information to the Right Eyes at the Right Time; Make Timely Decisions; Organize Work in Lean Processes; Rework in Clinical Studies; Backflow of Patient Data; Match Technology with Tasks; Objections to Adaptive Methods; Integrity and Validity; The Regulatory Environment The Complexity of Clinical ResearchConclusion; References; 3 Design Adaptations Part One: Finding the Right Dose; Background; Types of Design Adaptations; Order of Discussion; Dosing Nomenclature; Determining Maximum Safe Dose; Single Arm; Continual Reassessment Method; Other Bayesian Dose-Finding Methods; Determining Optimal Dose (Pruning); Multiple Arms; Improvements over Conventional Approaches to Dose Finding; Dose Selection in Practice; Optimizing Dose Selection; Minimizing Costs Versus Maximizing Information; Surrogate Endpoints; Conclusion; References 4 Design Adaptations Part Two: Additional Design ChangesSample-Size Reestimation; The Trouble with Planning Estimates; The High Cost of "Underbuilt" Studies; The Benefits of Reestimation and Rightsizing; Reestimation and Trial Stages; Rules to Restrict Reestimation; Adjusting Sample Size for Nuisance Parameters; Seamless Designs: Combining Multiple Phases; When to Consider Seamless Studies; Seamless Phase I/Phase II Trials; Seamless Phase II/Phase III Trials; Planning Issues in Seamless Trials; Phase I-II-III Designs; Adaptive Randomization; Response-Adaptive Randomization Other Forms of Adaptive RandomizationOther Types of Design Adaptations; Noninferiority-to-Superiority Design; Adaptive Hypotheses and Subpopulations; Treatment Switching; Conclusions; References; 5 Operational Adaptations; Design and Operational Adaptations; The Nature and Significance of Operational Adaptations; Implementing Operational Adaptations; Enrollment and Other Site Issues; Data Quality; Monitoring; Site Closeout and Database Lock; Supporting Functions for Efficient Operations; The Bottom Line; References; 6 Agile Clinical Development; Benefits of Agile Development A Development Example |
| Record Nr. | UNINA-9910140620203321 |
|
Rosenberg Michael J
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| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||