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Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem
| Design, execution, and management of medical device clinical trials [[electronic resource] /] / Salah Abdel-aleem |
| Autore | Abdel-aleem Salah |
| Pubbl/distr/stampa | Hoboken, N.J., : John Wiley & Sons, c2009 |
| Descrizione fisica | 1 online resource (296 p.) |
| Disciplina | 610.28/4 |
| Soggetto topico |
Medical instruments and apparatus - Research
Clinical trials |
| ISBN |
1-282-27905-X
9786612279058 0-470-47591-9 0-470-47590-0 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
DESIGN, EXECUTION, AND MANAGEMENT OF MEDICAL DEVICE CLINICAL TRIALS; CONTENTS; List of Abbreviations; Preface; Acknowledgments; 1 An Overview of Clinical Study Tasks and Activities; Key Clinical Study Tasks and Activities; Discussion of Key Tasks and Activities; Management of Key Clinical Tasks and Activities; Example of the Spread Sheet for Managing Clinical Study Activities; The Clinical Research Team
2 Development of Clinical Protocols, Case Report Forms, Clinical Standard Operating Procedures, Informed Consent Form, Study Regulatory Binder, Study Research Agreement, and Other Clinical Materials Clinical Protocol; Case Report Forms (CRFs); Example of the Case Report Form Template; Informed Consent Form (ICF); Instructions for Use of Device; Study Regulatory Binder; Study Research Agreement; Research Agreement Template; Research Contract Challenges; Clinical Forms and Certificates; Clinical Standard Operating Procedures (SOPs) 3 Qualification/Selection of Study Investigators and Study Monitoring Visits Qualification and Selection of Investigators; Monitoring Visits; Monitoring Reports; Interim Monitoring Visit Report Template; 4 Adverse Events Definitions and Reporting Procedures; Adverse Event Definitions; Policies, Regulations, and Guidelines Regarding Adverse Event Reporting; Adverse Event Reporting Pathway; Terms for Causality Assessment; GAPS/Challenges in Adverse Event Reporting; Adverse Event Reporting Time Periods (21 CFR 803); Differences between the United States and Europe in Reporting Adverse Events Serious Adverse Event Narratives Classification of Adverse Events; Special Requirement for Reporting Certain Adverse Events; Case Example; Mandatory Device Reporting for FDA-Approved Devices; 5 Statistical Analysis Plan (SAP) and Biostatistics in Clinical Research; Statistical Analysis Plan (SAP); Selection of Study Endpoints; Biostatistics in Clinical Research; 6 Final Clinical Study Report; Final Clinical Report's Outline; Discussion of Sections in the Final Clinical Report; 7 Medical Device Regulations, Combination Product, Study Committees, and FDA-Sponsor Meetings Medical Device Regulations Combination Products; Study Committees; FDA-Sponsor Meetings; Registration of Clinical Trials; Implementation of the HIPAA Privacy Rule in Clinical Research; Institutional Review Boards (IRB); FDA's Oversight of Clinical Trials (Bioresearch Monitoring); Code of Federal Regulations of Medical Devices; 8 Design Issues in Medical Devices Studies; Design of the Clinical Trial; Assumptions and Parameters of Clinical Trial Design; Clinical Trials' Design Issues and Data Analysis Issues; Use of Historic Controls as the Control Group in IDE Studies Summary of Recommendations When Using Historic Controls |
| Record Nr. | UNINA-9910827440103321 |
Abdel-aleem Salah
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| Hoboken, N.J., : John Wiley & Sons, c2009 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Designing clinical research / / Stephen B Hulley [and four others]
| Designing clinical research / / Stephen B Hulley [and four others] |
| Edizione | [Fourth edition.] |
| Pubbl/distr/stampa | Philadelphia : , : Wolters Kluwer/Lippincott Williams & Wilkins, , [2013] |
| Descrizione fisica | 1 online resource (381 pages) |
| Disciplina | 610.72 |
| Altri autori (Persone) | HulleyStephen B |
| Soggetto topico | Clinical trials |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-4698-4053-7
1-4698-4054-5 1-4698-7533-0 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | section I. Basic ingredients -- section II. Study designs -- section III. Implementation. |
| Record Nr. | UNINA-9910464171303321 |
| Philadelphia : , : Wolters Kluwer/Lippincott Williams & Wilkins, , [2013] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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La donaci̤n del cerebro: un regalo para las generaciones futuras
| La donaci̤n del cerebro: un regalo para las generaciones futuras |
| Pubbl/distr/stampa | [Bethesda, Md.] : , : National Institute on Aging, National Institutes of Health, , 2020 |
| Descrizione fisica | 1 online resource : color illustrations |
| Soggetto topico |
Donation of organs, tissues, etc
Clinical trials Memory - Age factors Alzheimer's disease Dementia |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Record Nr. | UNINA-9910716859903321 |
| [Bethesda, Md.] : , : National Institute on Aging, National Institutes of Health, , 2020 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
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Drug regimen compliance : issues in clinical trials and patient management
| Drug regimen compliance : issues in clinical trials and patient management |
| Pubbl/distr/stampa | [Place of publication not identified], : Wiley, 1999 |
| Descrizione fisica | 1 online resource (203 pages) |
| Disciplina | 615/.1 |
| Soggetto topico |
Patient compliance - Dosage
Drugs Clinical trials Clinical Trials as Topic Patient Compliance Pharmaceutical Preparations Patient Acceptance of Health Care Evaluation Studies as Topic Health Behavior Epidemiologic Methods Behavior Investigative Techniques Health Care Evaluation Mechanisms Attitude to Health Behavior and Behavior Mechanisms Public Health Quality of Health Care Delivery of Health Care Health Care Quality, Access, and Evaluation Environment and Public Health Health Care Medical Professional Practice Medicine Health & Biological Sciences |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-55486-X
9786610554867 0-470-85202-X 0-470-84633-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910146063703321 |
| [Place of publication not identified], : Wiley, 1999 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug regimen compliance : issues in clinical trials and patient management
| Drug regimen compliance : issues in clinical trials and patient management |
| Pubbl/distr/stampa | [Place of publication not identified], : Wiley, 1999 |
| Descrizione fisica | 1 online resource (203 pages) |
| Disciplina | 615/.1 |
| Soggetto topico |
Patient compliance - Dosage
Drugs Clinical trials Clinical Trials as Topic Patient Compliance Pharmaceutical Preparations Patient Acceptance of Health Care Evaluation Studies as Topic Health Behavior Epidemiologic Methods Behavior Investigative Techniques Health Care Evaluation Mechanisms Attitude to Health Behavior and Behavior Mechanisms Public Health Quality of Health Care Delivery of Health Care Health Care Quality, Access, and Evaluation Environment and Public Health Health Care Medical Professional Practice Medicine Health & Biological Sciences |
| ISBN |
1-280-55486-X
9786610554867 0-470-85202-X 0-470-84633-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910830458703321 |
| [Place of publication not identified], : Wiley, 1999 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Drug regimen compliance : issues in clinical trials and patient management
| Drug regimen compliance : issues in clinical trials and patient management |
| Pubbl/distr/stampa | [Place of publication not identified], : Wiley, 1999 |
| Descrizione fisica | 1 online resource (203 pages) |
| Disciplina | 615/.1 |
| Soggetto topico |
Patient compliance - Dosage
Drugs Clinical trials Clinical Trials as Topic Patient Compliance Pharmaceutical Preparations Patient Acceptance of Health Care Evaluation Studies as Topic Health Behavior Epidemiologic Methods Behavior Investigative Techniques Health Care Evaluation Mechanisms Attitude to Health Behavior and Behavior Mechanisms Public Health Quality of Health Care Delivery of Health Care Health Care Quality, Access, and Evaluation Environment and Public Health Health Care Medical Professional Practice Medicine Health & Biological Sciences |
| ISBN |
1-280-55486-X
9786610554867 0-470-85202-X 0-470-84633-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9910840506303321 |
| [Place of publication not identified], : Wiley, 1999 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Early drug development [[electronic resource] ] : strategies and routes to first-in-human trials / / edited by Mitchell N. Cayen
| Early drug development [[electronic resource] ] : strategies and routes to first-in-human trials / / edited by Mitchell N. Cayen |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (658 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | CayenM. N |
| Soggetto topico |
Drug development
Clinical trials |
| ISBN |
1-118-03520-8
1-283-91645-2 0-470-61319-X 0-470-61317-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
EARLY DRUG DEVELOPMENT; CONTENTS; Contributors; Foreword; Preface; PART I INTRODUCTION; 1 Drug Discovery and Early Drug Development; References; PART II LEAD OPTIMIZATION STRATEGIES; 2 ADME Strategies in Lead Optimization; 3 Prediction of Pharmacokinetics and Drug Safety in Humans; 4 Bioanalytical Strategies; PART III BRIDGING FROM DISCOVERY TO DEVELOPMENT; 5 Chemistry, Manufacturing, and Controls: The Drug Substance and Formulated Drug Product; 6 Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials; PART IV PRE-IND DRUG DEVELOPMENT
7 Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine8 Toxicokinetics in Support of Drug Development; 9 Good Laboratory Practice; PART V PLANNING THE FIRST-IN-HUMAN STUDY AND REGULATORY SUBMISSION; 10 Estimation of Human Starting Dose for Phase I Clinical Programs; 11 Exploratory INDs/CTAs; 12 Unique Considerations for Biopharmaceutics; 13 Project Management and International Regulatory Requirements and Strategies for First-in-Human Trials; 14 First-in-Human Regulatory Submissions; Appendix 1: Abbreviations and Acronyms Appendix 2: Definitions and Glossary of TermsAppendix 3: Some Relevant Government and Regulatory Documents; Appendix 4: Some Relevant Resources with Web Sites; Index |
| Record Nr. | UNINA-9910140776803321 |
| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Early drug development [[electronic resource] ] : strategies and routes to first-in-human trials / / edited by Mitchell N. Cayen
| Early drug development [[electronic resource] ] : strategies and routes to first-in-human trials / / edited by Mitchell N. Cayen |
| Pubbl/distr/stampa | Hoboken, N.J., : Wiley, c2010 |
| Descrizione fisica | 1 online resource (658 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) | CayenM. N |
| Soggetto topico |
Drug development
Clinical trials |
| ISBN |
1-118-03520-8
1-283-91645-2 0-470-61319-X 0-470-61317-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
EARLY DRUG DEVELOPMENT; CONTENTS; Contributors; Foreword; Preface; PART I INTRODUCTION; 1 Drug Discovery and Early Drug Development; References; PART II LEAD OPTIMIZATION STRATEGIES; 2 ADME Strategies in Lead Optimization; 3 Prediction of Pharmacokinetics and Drug Safety in Humans; 4 Bioanalytical Strategies; PART III BRIDGING FROM DISCOVERY TO DEVELOPMENT; 5 Chemistry, Manufacturing, and Controls: The Drug Substance and Formulated Drug Product; 6 Nonclinical Safety Pharmacology Studies Recommended for Support of First-in-Human Clinical Trials; PART IV PRE-IND DRUG DEVELOPMENT
7 Toxicology Program to Support Initiation of a Clinical Phase I Program for a New Medicine8 Toxicokinetics in Support of Drug Development; 9 Good Laboratory Practice; PART V PLANNING THE FIRST-IN-HUMAN STUDY AND REGULATORY SUBMISSION; 10 Estimation of Human Starting Dose for Phase I Clinical Programs; 11 Exploratory INDs/CTAs; 12 Unique Considerations for Biopharmaceutics; 13 Project Management and International Regulatory Requirements and Strategies for First-in-Human Trials; 14 First-in-Human Regulatory Submissions; Appendix 1: Abbreviations and Acronyms Appendix 2: Definitions and Glossary of TermsAppendix 3: Some Relevant Government and Regulatory Documents; Appendix 4: Some Relevant Resources with Web Sites; Index |
| Record Nr. | UNINA-9910821642403321 |
| Hoboken, N.J., : Wiley, c2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Estudios clínicos [[electronic resource] ] : preguntas y respuestas
| Estudios clínicos [[electronic resource] ] : preguntas y respuestas |
| Pubbl/distr/stampa | [Bethesda, Md.] : , : National Cancer Institute, , [2008] |
| Descrizione fisica | 13 pages : digital, PDF file |
| Collana | Hojas informativas |
| Soggetto topico |
Clinical trials
Cancer - Treatment |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | spa |
| Altri titoli varianti | Estudios clínicos |
| Record Nr. | UNINA-9910697339203321 |
| [Bethesda, Md.] : , : National Cancer Institute, , [2008] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Evidence-based outcome research [[electronic resource] ] : a practical guide to conducting randomized controlled trials for psychosocial interventions / / edited by Arthur M. Nezu & Christine Maguth Nezu
| Evidence-based outcome research [[electronic resource] ] : a practical guide to conducting randomized controlled trials for psychosocial interventions / / edited by Arthur M. Nezu & Christine Maguth Nezu |
| Pubbl/distr/stampa | Oxford ; ; New York, : Oxford University Press, c2008 |
| Descrizione fisica | 1 online resource (513 p.) |
| Disciplina | 616.89 |
| Altri autori (Persone) |
NezuArthur M
NezuChristine M |
| Soggetto topico |
Evidence-based psychiatry
Psychiatry - Research - Methodology Psychotherapy - Research - Methodology Clinical trials |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-19-026165-X
1-281-16298-1 9786611162986 0-19-804145-4 1-4356-0095-9 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Contents; About the Editors; About the Contributors; SECTION I: CONCEPTUAL ISSUES; SECTION II: ASSESSMENT ISSUES; SECTION III: METHODOLOGICAL AND DESIGN ISSUES; SECTION IV: DATA ANALYSIS ISSUES; SECTION V: SPECIAL TOPICS; Index |
| Record Nr. | UNINA-9910452099103321 |
| Oxford ; ; New York, : Oxford University Press, c2008 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Soggetto topico
-
Clinical trials
(243)
- Clinical Trials as Topic (26)
- Drugs - Testing (25)
- Medicine - Research (11)
- Clinical medicine - Research (9)