Info
- Utilizzare la checkbox di selezione a fianco di ciascun documento per attivare le funzionalità di stampa, invio email, download nei formati disponibili del (i) record.
Assuring data quality and validity in clinical trials for regulatory decision making [[electronic resource] ] : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors
| Assuring data quality and validity in clinical trials for regulatory decision making [[electronic resource] ] : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, c1999 |
| Descrizione fisica | 1 online resource (88 p.) |
| Disciplina | 615/.1 |
| Altri autori (Persone) | DavisJonathan R |
| Collana | The compass series |
| Soggetto topico | Clinical trials - Quality control |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-309-52024-X
0-585-14261-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and Acronyms |
| Record Nr. | UNINA-9910456122403321 |
| Washington, DC, : National Academy Press, c1999 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Assuring data quality and validity in clinical trials for regulatory decision making [[electronic resource] ] : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors
| Assuring data quality and validity in clinical trials for regulatory decision making [[electronic resource] ] : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, c1999 |
| Descrizione fisica | 1 online resource (88 p.) |
| Disciplina | 615/.1 |
| Altri autori (Persone) | DavisJonathan R |
| Collana | The compass series |
| Soggetto topico | Clinical trials - Quality control |
| ISBN |
0-309-17280-2
0-309-52024-X 0-585-14261-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and Acronyms |
| Record Nr. | UNINA-9910778746103321 |
| Washington, DC, : National Academy Press, c1999 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors
| Assuring data quality and validity in clinical trials for regulatory decision making : workshop report : Roundtable on Research and Development of Drugs, Biologics, and Medical Devices / / Jonathan R. Davis ... [et al.] editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, c1999 |
| Descrizione fisica | 1 online resource (88 p.) |
| Disciplina | 615/.1 |
| Altri autori (Persone) | DavisJonathan R |
| Collana | The compass series |
| Soggetto topico | Clinical trials - Quality control |
| ISBN |
0-309-17280-2
0-309-52024-X 0-585-14261-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Front Matter; Preface; Acknowledgments; Contents; Executive Summary; Introduction; Presubmission and Submission; FDA Regulatory Review; Summary of Issues; Directions for the Future; Final Comments; APPENDIX A Workshop Agenda; APPENDIX B Speakers and Panelists; APPENDIX C Workshop Registrants; APPENDIX D Glossary and Acronyms |
| Record Nr. | UNINA-9910816117003321 |
| Washington, DC, : National Academy Press, c1999 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emerging infectious diseases from the global to the local perspective [[electronic resource] ] : a summary of a workshop of the Forum on Emerging Infections / / Jonathan R. Davis and Joshua Lederberg, editors
| Emerging infectious diseases from the global to the local perspective [[electronic resource] ] : a summary of a workshop of the Forum on Emerging Infections / / Jonathan R. Davis and Joshua Lederberg, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c2001 |
| Descrizione fisica | xiv, 118 p. : ill., maps |
| Disciplina | 614.5/9 |
| Altri autori (Persone) |
DavisJonathan R
LederbergJoshua |
| Soggetto topico |
Emerging infectious diseases - Epidemiology
Medical geography World health |
| Soggetto genere / forma | Electronic books. |
| ISBN | 0-309-56482-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910455998303321 |
| Washington, D.C., : National Academy Press, c2001 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emerging infectious diseases from the global to the local perspective [[electronic resource] ] : a summary of a workshop of the Forum on Emerging Infections / / Jonathan R. Davis and Joshua Lederberg, editors
| Emerging infectious diseases from the global to the local perspective [[electronic resource] ] : a summary of a workshop of the Forum on Emerging Infections / / Jonathan R. Davis and Joshua Lederberg, editors |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c2001 |
| Descrizione fisica | xiv, 118 p. : ill., maps |
| Disciplina | 614.5/9 |
| Altri autori (Persone) |
DavisJonathan R
LederbergJoshua |
| Soggetto topico |
Emerging infectious diseases - Epidemiology
Medical geography World health |
| ISBN |
0-309-17110-5
0-309-56482-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778613703321 |
| Washington, D.C., : National Academy Press, c2001 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Emerging infectious diseases from the global to the local perspective : a summary of a workshop of the Forum on Emerging Infections / / Jonathan R. Davis and Joshua Lederberg, editors
| Emerging infectious diseases from the global to the local perspective : a summary of a workshop of the Forum on Emerging Infections / / Jonathan R. Davis and Joshua Lederberg, editors |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, D.C., : National Academy Press, c2001 |
| Descrizione fisica | xiv, 118 p. : ill., maps |
| Disciplina | 614.5/9 |
| Altri autori (Persone) |
DavisJonathan R
LederbergJoshua |
| Soggetto topico |
Emerging infectious diseases - Epidemiology
Medical geography World health |
| ISBN |
0-309-17110-5
0-309-56482-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
EMERGING INFECTIOUS DISEASES FROM THE GLOBAL TO THE LOCAL PERSPECTIVE -- Copyright -- REVIEWERS -- Preface -- ABOUT THE WORKSHOP -- ORGANIZATION OF WORKSHOP SUMMARY -- ACKNOWLEDGMENTS -- Contents -- Summary and Assessment -- EMERGING INFECTIONS: THE GLOBAL PICTURE -- Financial Costs of Infectious Diseases -- Infectious Diseases and Human Rights -- FACTORS IN EMERGENCE OF INFECTIOUS DISEASES -- Global Trade and Travel -- Seasonality and Climate Variation -- Zoonoses -- Food Safety -- Antimicrobial Drug Use in Animals and Humans -- Slowed Vaccine and Drug Development and Degraded Immunization Policies -- NEED FOR COORDINATION AND COLLABORATION -- Cooperation Across Borders -- Bilateral Agreements -- International Health Regulations -- NETWORKS OF GLOBAL SURVEILLANCE -- Continuing Need for Local Surveillance -- Preservation of Samples -- Using the Internet for Reporting and Communication -- TAKING ADVANTAGE OF WINDOWS OF OPPORTUNITY -- 1 Introduction -- LOST WINDOWS OF OPPORTUNITY -- GLOBAL RESPONSES TO EMERGING INFECTIONS -- WINDOWS OF OPPORTUNITY FOR THE FUTURE -- 2 Emerging Infections in Latin America -- OVERVIEW -- EMERGING INFECTIONS IN COLOMBIA: A NATIONAL PERSPECTIVE -- Environmental Changes -- Human Demographics, Mosquito Behavior, and Deforestation -- Emerging Antimicrobial Resistance -- Complacency and Natural Disasters -- Conclusion -- A NATIONAL STRATEGY FOR EMERGING INFECTIOUS DISEASES: THE ARGENTINE CASE OF 1999 -- Argentine Hemorrhagic Fever -- HIV/AIDS -- Leishmaniasis -- Cholera Epidemic -- Hemolytic-Uremic Syndrome -- Bacterial Antibiotic Resistance -- Multidrug Tuberculosis Resistance -- Hantavirus Pulmonary Syndrome -- Dengue -- Bilateral and Multilateral Agreements -- DIAGNOSIS, EPIDEMIOLOGICAL SURVEILLANCE, AND CONTROL PROGRAMS FOR EMERGING AND RE-EMERGING INFECTIOUS DISEASES IN MEXICO -- Dengue -- Leptospirosis -- Tuberculosis.
HIV/AIDS -- Other Emerging and Reemerging Diseases -- Surveillance in Response to Natural Disasters -- RESPONSE OF THE PAN AMERICAN HEALTH ORGANIZATION TO COMBATING EMERGING INFECTIOUS DISEASES IN LATIN ... -- 3 Emerging Infections in Africa -- OVERVIEW -- INTEGRATED DISEASE SURVEILLANCE AND EPIDEMICS: PREPAREDNESS AND RESPONSE IN AFRICA -- GLOBAL EMERGING INFECTIOUS DISEASES -- DOD's Expanded Role -- DOD Involvement in Rift Valley Fever Outbreak -- Syndromic Surveillance in Indonesia -- Integrating Surveillance in the Caribbean -- Facilitating Training and Capacity Building -- EMERGING INFECTIONS IN AFRICA: THE WHO RESPONSE -- Global Epidemic Intelligence -- Use of the Internet -- Disease Distribution and Verification -- Outbreak Response Role of WHO -- 4 Emerging Infections in Asia and the Pacific Region -- OVERVIEW -- EMERGING INFECTIOUS DISEASES IN HONG KONG AND THEIR PUBLIC HEALTH SIGNIFICANCE -- Influenza A Virus (H5N1) -- Avian H9N2 Viruses -- Swine Influenza A Virus (H3N2) -- Conclusion -- EMERGING DISEASES IN THE AUSTRALASIAN REGION -- Japanese Encephalitis Virus -- Dengue -- Other Emerging Diseases -- INTERNATIONAL SMART PARTNERSHIP IN EMERGING DISEASES: SENSE AND SENSITIVITY -- Introduction -- Emerging Infections in Malaysia -- Lessons Learned -- 5 Emerging Infections in Europe -- OVERVIEW -- PANDEMIC STRATEGIC PLANNING -- Pandemic Influenza Contingency Plan in the United Kingdom -- The Hong Kong Influenza A Virus Outbreak -- European Response to Emerging Infectious Diseases -- Importance of Local Surveillance and Collaboration -- A VIEW FROM THE GROUND: TUBERCULOSIS AS AN EXAMPLE OF A REEMERGING INFECTIOUS DISEASE IN THE FORMER SOVIET UNION -- Introduction -- Reemergence of Infectious Disease in the Former Soviet Union -- Political and Economic Causes of TB Reemergence -- Special Problems of the Prisons. Role of Nongovernmental Organizations -- Conclusion -- EUROPEAN RESPONSES TO EMERGING INFECTIONS AND THEIR POLICY IMPLICATIONS -- References -- APPENDIX A Glossary and Acronyms -- APPENDIX B Workshop Agenda -- APPENDIX C Workshop Participants -- APPENDIX D Forum Member and Staff Biographies -- FORUM MEMBERS -- STUDY STAFF. |
| Record Nr. | UNINA-9910817432803321 |
| Washington, D.C., : National Academy Press, c2001 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Managed care systems and emerging infections [[electronic resource] ] : challenges and opportunities for strengthening surveillance, research, and prevention : workshop summary, based on a workshop of the Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine / / Jonathan R. Davis, editor
| Managed care systems and emerging infections [[electronic resource] ] : challenges and opportunities for strengthening surveillance, research, and prevention : workshop summary, based on a workshop of the Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine / / Jonathan R. Davis, editor |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, 2000 |
| Descrizione fisica | 1 online resource (127 p.) |
| Disciplina | 362.1/04258 |
| Altri autori (Persone) | DavisJonathan R |
| Soggetto topico |
Emerging infectious diseases
Managed care plans (Medical care) |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-18563-5
9786610185634 0-309-59388-3 0-585-25990-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910456160203321 |
| Washington, DC, : National Academy Press, 2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Managed care systems and emerging infections [[electronic resource] ] : challenges and opportunities for strengthening surveillance, research, and prevention : workshop summary, based on a workshop of the Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine / / Jonathan R. Davis, editor
| Managed care systems and emerging infections [[electronic resource] ] : challenges and opportunities for strengthening surveillance, research, and prevention : workshop summary, based on a workshop of the Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine / / Jonathan R. Davis, editor |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, 2000 |
| Descrizione fisica | 1 online resource (127 p.) |
| Disciplina | 362.1/04258 |
| Altri autori (Persone) | DavisJonathan R |
| Soggetto topico |
Emerging infectious diseases
Managed care plans (Medical care) |
| ISBN |
0-309-17228-4
1-280-18563-5 9786610185634 0-309-59388-3 0-585-25990-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910778749403321 |
| Washington, DC, : National Academy Press, 2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Managed care systems and emerging infections : challenges and opportunities for strengthening surveillance, research, and prevention : workshop summary, based on a workshop of the Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine / / Jonathan R. Davis, editor
| Managed care systems and emerging infections : challenges and opportunities for strengthening surveillance, research, and prevention : workshop summary, based on a workshop of the Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine / / Jonathan R. Davis, editor |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Washington, DC, : National Academy Press, 2000 |
| Descrizione fisica | 1 online resource (127 p.) |
| Disciplina | 362.1/04258 |
| Altri autori (Persone) | DavisJonathan R |
| Soggetto topico |
Emerging infectious diseases
Managed care plans (Medical care) |
| ISBN |
0-309-17228-4
1-280-18563-5 9786610185634 0-309-59388-3 0-585-25990-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Managed Care Systems and Emerging Infections -- Copyright -- REVIEWERS -- Preface -- Contents -- Summary -- BASIC AND CLINICAL RESEARCH -- CLINICAL PRACTICE GUIDELINES -- SURVEILLANCE AND MONITORING -- EDUCATION AND OUTREACH -- DRUG FORMULARIES -- 1 Introduction -- BACKGROUND -- ABOUT THE WORKSHOP AND ORGANIZATION OF THE WORKSHOP SUMMARY -- 2 Conducting Basic and Clinical Research in the Managed Care Setting -- PERSPECTIVE OF ASSOCIATION OF AMERICAN MEDICAL COLLEGES ON BASIC AND CLINICAL RESEARCH -- OPPORTUNITIES FOR POPULATION-BASED CLINICAL RESEARCH USING DATA FROM MANAGED CARE ORGANIZATIONS -- CONDUCTING CLINICAL RESEARCH WITHIN MANAGED CARE ORGANIZATIONS -- NIH ACTIVITIES RELATED TO CLINICAL RESEARCH AND MANAGED CARE -- SUMMARY OF CHALLENGES AND OPPORTUNITIES -- Supporting the Functions of Academic Health Centers -- Ensuring Adequate Databases for Clinical Research -- Exploiting the Unique Advantages of Managed Care for Surveillance and Research -- Promoting Collaboration -- Summary -- 3 Clinical Practice Guidelines -- CLINICAL PRACTICE GUIDELINES FOR EMERGING INFECTIONS AND MANAGED CARE -- REALITIES OF IMPLEMENTING GUIDELINES -- MAKING GUIDELINES INSTRUMENTAL: THEORY VERSUS PRACTICE -- SUMMARY OF CHALLENGES AND OPPORTUNITIES -- Promoting Adoption and Use of Guidelines in Managed Care Organizations -- Involving Clinicians in Guideline Development and Implementation -- The Need for Systemwide, Standardized Guidelines -- Promoting Professional and Public Education -- Summary -- 4 Surveillance and Monitoring -- AN EMPLOYER'S PERSPECTIVE -- MANAGED CARE AND INFECTIOUS DISEASE SURVEILLANCE: OPPORTUNITIES FOR COLLABORATION -- COLLABORATIVE SURVEILLANCE EFFORTS AND MONITORING OF DATA -- LATTER DAY SAINTS HOSPITAL'S SYSTEM -- LABORATORY-BASED REPORTING AND MANAGING ENCOUNTER-LEVEL DATA -- LABORATORY-BASED REPORTING ISSUES -- LEGAL CONCERNS.
SUMMARY OF CHALLENGES AND OPPORTUNITIES -- Understanding Professional Roles in Surveillance and Monitoring -- Ensuring Availability of Data -- Promoting Sharing of Data -- Tracking Nosocomial Infections -- Accurate Reporting of Encounter-Level Data -- Overcoming Structural Barriers -- Summary -- 5 Education and Outreach -- COORDINATING HEALTH PLAN RESEARCH AND EDUCATIONAL EFFORTS -- IMPACTS OF MANAGED CARE SYSTEM'S EDUCATIONAL EFFORTS ON CONTROL OF ANTIBIOTIC USE -- EDUCATION AND OUTREACH PERSPECTIVES OF THE NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES -- MANAGED CARE SYSTEMS AND EMERGING INFECTIONS: EDUCATION AND OUTREACH -- SUMMARY OF CHALLENGES AND OPPORTUNITIES -- Promote Professional Education Efforts -- Encourage Judicious Antibiotic Use -- Invest in Educational Programs -- Summary -- 6 Drug Formularies -- REGULATORY ISSUES -- RELATIONSHIP BETWEEN MANAGED CARE FORMULARIES AND TREATMENT OUTCOMES -- BACTERIAL RESISTANCE, THE ANTIBIOTIC FORMULARY, AND OTHER MANAGEMENT STRATEGIES -- ECONOMICS OF RESTRICTIONS ON PHARMACEUTICALS -- SUMMARY OF CHALLENGES AND OPPORTUNITIES -- Ensuring Availability of Current Information on New Drugs -- Managing Antibiotic Selective Pressure -- Need for New Management Strategies for Cost Reduction -- Achieving Quality Care and Cost Containment -- Summary -- 7 Concluding Remarks -- References -- Appendix A Veterans Health Administration and Infectious Disease -- CLINICAL RESEARCH -- CLINICAL PRACTICE -- Information Technology -- Homelessness -- SURVEILLANCE AND MONITORING -- Emerging Pathogens Initiative -- Annual Infectious Diseases and Infection Control Report -- EDUCATION -- DRUG FORMULARY -- Appendix B Glossary and Acronyms -- Acronyms -- Glossary -- Appendix C Workshop Agenda -- Appendix D Forum Member and Staff Biographies -- FORUM MEMBERS -- STUDY STAFF. |
| Record Nr. | UNINA-9910810769803321 |
| Washington, DC, : National Academy Press, 2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Public health systems and emerging infections [[electronic resource] ] : assessing the capabilities of the public and private sectors : workshop summary / / Jonathan R. Davis and Joshua Lederberg, editors
| Public health systems and emerging infections [[electronic resource] ] : assessing the capabilities of the public and private sectors : workshop summary / / Jonathan R. Davis and Joshua Lederberg, editors |
| Pubbl/distr/stampa | Washington, D.C. ; ; [Great Britain], : National Academy Press, 2000 |
| Descrizione fisica | 1 online resource (128 p.) |
| Disciplina | 362.1969 |
| Altri autori (Persone) |
DavisJonathan R
LederbergJoshua |
| Soggetto topico |
Communicable diseases - Prevention
Epidemics - Prevention Public health |
| Soggetto genere / forma | Electronic books. |
| ISBN | 0-309-55817-4 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | ""Front Matterr""; ""REVIEWERS""; ""Preface""; ""ACKNOWLEDGMENTS""; ""Contents""; ""Summary and Assessment""; ""1 Introduction""; ""2 Epidemiological Investigation""; ""3 Surveillance""; ""4 Communication, Coordination, and Education and Outreach""; ""5 Strategic Planning, Resource Allocation, and Economic Support""; ""References""; ""APPENDIX A Glossary and Acronyms""; ""APPENDIX B Workshop Agenda""; ""APPENDIX C Emerging Infectious Diseases: Consensus on Needed Laboratory Capacity Could Strengthen Surveillance""; ""APPENDIX D Forum Member and Staff Biographies"" |
| Record Nr. | UNINA-9910456101203321 |
| Washington, D.C. ; ; [Great Britain], : National Academy Press, 2000 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
