Guidance for industry [[electronic resource] ] : E6 good clinical practice, consolidated guidance |
Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Control : , : Center for Biologics Evaluation and Research, , [1996] |
Descrizione fisica | iii, 58 pages : digital, PDF file |
Soggetto topico | Clinical trials |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Guidance for industry |
Record Nr. | UNINA-9910698972703321 |
Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Control : , : Center for Biologics Evaluation and Research, , [1996] | ||
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Lo trovi qui: Univ. Federico II | ||
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Guidance on nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals [[electronic resource]] |
Pubbl/distr/stampa | [Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [2008] |
Descrizione fisica | iii, 20 pages : digital, PDF file |
Soggetto topico |
Clinical trials
Drugs - Testing |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Altri titoli varianti | Nonclinical safety studies for the conduct of human clinical trials and marketing authorization for pharmaceuticals |
Record Nr. | UNINA-9910698761603321 |
[Rockville, MD] : , : [U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research], , [2008] | ||
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Lo trovi qui: Univ. Federico II | ||
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HANDBOOK FOR CLINICAL INVESTIGATORS |
Autore | KIRKPATRICK CHRISTOPHER |
Pubbl/distr/stampa | BOCA RATON, : CRC Press, 2002 |
Descrizione fisica | 1 online resource (85 p.) |
Disciplina |
610.72
615 |
Soggetto topico |
Clinical trials
Medicine - Research personnel Clinical medicine - Research Drugs - Testing |
Soggetto genere / forma | Electronic books. |
ISBN |
0-429-07896-X
1-4822-9539-3 1-280-11034-1 9786610110346 0-203-48407-X |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Book Cover; Title; Contents; Preface page; Motivation: What's in it for me?; Brief overview of drug development; Regulators and the Good Clinical Practice guidelines; The sponsor; Practical issues; running the trial; Publication; Postscript; Glossary and list of abbreviations; Notes; Index |
Record Nr. | UNINA-9910454682703321 |
KIRKPATRICK CHRISTOPHER
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BOCA RATON, : CRC Press, 2002 | ||
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Lo trovi qui: Univ. Federico II | ||
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HANDBOOK FOR CLINICAL INVESTIGATORS |
Autore | KIRKPATRICK CHRISTOPHER |
Pubbl/distr/stampa | BOCA RATON, : CRC Press, 2002 |
Descrizione fisica | 1 online resource (85 p.) |
Disciplina |
610.72
615 |
Soggetto topico |
Clinical trials
Medicine - Research personnel Clinical medicine - Research Drugs - Testing |
ISBN |
0-429-07896-X
1-4822-9539-3 1-280-11034-1 9786610110346 0-203-48407-X |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Book Cover; Title; Contents; Preface page; Motivation: What's in it for me?; Brief overview of drug development; Regulators and the Good Clinical Practice guidelines; The sponsor; Practical issues; running the trial; Publication; Postscript; Glossary and list of abbreviations; Notes; Index |
Record Nr. | UNINA-9910779910203321 |
KIRKPATRICK CHRISTOPHER
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BOCA RATON, : CRC Press, 2002 | ||
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Lo trovi qui: Univ. Federico II | ||
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HANDBOOK FOR CLINICAL INVESTIGATORS |
Autore | KIRKPATRICK CHRISTOPHER |
Pubbl/distr/stampa | BOCA RATON, : CRC Press, 2002 |
Descrizione fisica | 1 online resource (85 p.) |
Disciplina |
610.72
615 |
Soggetto topico |
Clinical trials
Medicine - Research personnel Clinical medicine - Research Drugs - Testing |
ISBN |
0-429-07896-X
1-4822-9539-3 1-280-11034-1 9786610110346 0-203-48407-X |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Book Cover; Title; Contents; Preface page; Motivation: What's in it for me?; Brief overview of drug development; Regulators and the Good Clinical Practice guidelines; The sponsor; Practical issues; running the trial; Publication; Postscript; Glossary and list of abbreviations; Notes; Index |
Record Nr. | UNINA-9910808411203321 |
KIRKPATRICK CHRISTOPHER
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||
BOCA RATON, : CRC Press, 2002 | ||
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Lo trovi qui: Univ. Federico II | ||
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Handbook for clinical research : design, statistics, and implementation / / editors Flora M. Hammond, [and others] |
Pubbl/distr/stampa | New York, New York : , : Demos Medical Publishing, LLC, , 2015 |
Descrizione fisica | 1 online resource (348 p.) |
Disciplina | 610.72/4 |
Collana | Rehabilitation Medicine Quick Reference |
Soggetto topico | Clinical trials |
Soggetto genere / forma | Electronic books. |
ISBN |
1-78539-066-X
1-61705-099-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
""Cover""; ""Title""; ""Copyright""; ""Contents""; ""Contributors""; ""Preface""; ""Share Handbook for Clinical Research: Design, Statistics, and Implementation""; ""Part I: Design""; ""Chapter 1: Development and Testing of Treatments""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Chapter 2: Qualitative Research""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""
""Suggested Readings""""Resources""; ""Chapter 3: Single-Case Experimental Designs""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Controls""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Resources""; ""Chapter 4: Studies of Associations""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 5: Observational Studies: Retrospective Versus Prospective"" ""Definitions and Descriptions""""Introduction""; ""Background and Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 6: Historical Controls""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 7: Subject as Own Control""; ""Definitions and Descriptions""; ""Background""; ""Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 8: Longitudinal Cohort Versus Cross-Sectional Cohort Studies"" ""Definitions and Descriptions""""Introduction""; ""Background and Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 9: Survey Research""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 10: Choice of Control Groups in Treatment Studies""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strategies""; ""Suggested Readings""; ""Resource""; ""Chapter 11: Randomization"" ""Definitions and Descriptions""""Introduction""; ""Implications""; ""Background""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Chapter 12: Special Issues in Randomized Controlled Trials""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Resources""; ""Chapter 13: Secondary Data Analysis""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings"" ""Resources"" |
Record Nr. | UNINA-9910459993003321 |
New York, New York : , : Demos Medical Publishing, LLC, , 2015 | ||
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Lo trovi qui: Univ. Federico II | ||
|
Handbook for clinical research : design, statistics, and implementation / / editors Flora M. Hammond, [and others] |
Pubbl/distr/stampa | New York, New York : , : Demos Medical Publishing, LLC, , 2015 |
Descrizione fisica | 1 online resource (348 p.) |
Disciplina | 610.72/4 |
Collana | Rehabilitation Medicine Quick Reference |
Soggetto topico | Clinical trials |
ISBN |
1-78539-066-X
1-61705-099-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
""Cover""; ""Title""; ""Copyright""; ""Contents""; ""Contributors""; ""Preface""; ""Share Handbook for Clinical Research: Design, Statistics, and Implementation""; ""Part I: Design""; ""Chapter 1: Development and Testing of Treatments""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Chapter 2: Qualitative Research""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""
""Suggested Readings""""Resources""; ""Chapter 3: Single-Case Experimental Designs""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Controls""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Resources""; ""Chapter 4: Studies of Associations""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 5: Observational Studies: Retrospective Versus Prospective"" ""Definitions and Descriptions""""Introduction""; ""Background and Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 6: Historical Controls""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 7: Subject as Own Control""; ""Definitions and Descriptions""; ""Background""; ""Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 8: Longitudinal Cohort Versus Cross-Sectional Cohort Studies"" ""Definitions and Descriptions""""Introduction""; ""Background and Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 9: Survey Research""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 10: Choice of Control Groups in Treatment Studies""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strategies""; ""Suggested Readings""; ""Resource""; ""Chapter 11: Randomization"" ""Definitions and Descriptions""""Introduction""; ""Implications""; ""Background""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Chapter 12: Special Issues in Randomized Controlled Trials""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Resources""; ""Chapter 13: Secondary Data Analysis""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings"" ""Resources"" |
Record Nr. | UNINA-9910787200603321 |
New York, New York : , : Demos Medical Publishing, LLC, , 2015 | ||
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Lo trovi qui: Univ. Federico II | ||
|
Handbook for clinical research : design, statistics, and implementation / / editors Flora M. Hammond, [and others] |
Pubbl/distr/stampa | New York, New York : , : Demos Medical Publishing, LLC, , 2015 |
Descrizione fisica | 1 online resource (348 p.) |
Disciplina | 610.72/4 |
Collana | Rehabilitation Medicine Quick Reference |
Soggetto topico | Clinical trials |
ISBN |
1-78539-066-X
1-61705-099-7 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto |
""Cover""; ""Title""; ""Copyright""; ""Contents""; ""Contributors""; ""Preface""; ""Share Handbook for Clinical Research: Design, Statistics, and Implementation""; ""Part I: Design""; ""Chapter 1: Development and Testing of Treatments""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Chapter 2: Qualitative Research""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""
""Suggested Readings""""Resources""; ""Chapter 3: Single-Case Experimental Designs""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Controls""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Resources""; ""Chapter 4: Studies of Associations""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 5: Observational Studies: Retrospective Versus Prospective"" ""Definitions and Descriptions""""Introduction""; ""Background and Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 6: Historical Controls""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 7: Subject as Own Control""; ""Definitions and Descriptions""; ""Background""; ""Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 8: Longitudinal Cohort Versus Cross-Sectional Cohort Studies"" ""Definitions and Descriptions""""Introduction""; ""Background and Implications""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 9: Survey Research""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Chapter 10: Choice of Control Groups in Treatment Studies""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strategies""; ""Suggested Readings""; ""Resource""; ""Chapter 11: Randomization"" ""Definitions and Descriptions""""Introduction""; ""Implications""; ""Background""; ""Strategies""; ""Pitfalls""; ""Helpful Hints""; ""Suggested Readings""; ""Chapter 12: Special Issues in Randomized Controlled Trials""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings""; ""Resources""; ""Chapter 13: Secondary Data Analysis""; ""Definitions and Descriptions""; ""Introduction""; ""Implications""; ""Background""; ""Strengths""; ""Weaknesses""; ""Strategies""; ""Suggested Readings"" ""Resources"" |
Record Nr. | UNINA-9910807874003321 |
New York, New York : , : Demos Medical Publishing, LLC, , 2015 | ||
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Lo trovi qui: Univ. Federico II | ||
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Handbook for clinical trials of imaging and image-guided interventions / / edited by Nancy A. Obuchowski and G. Scott Gazelle |
Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley Blackwell, , 2016 |
Descrizione fisica | 1 online resource (226 p.) |
Disciplina | 616.07/54 |
Soggetto topico |
Diagnostic imaging
Clinical trials |
ISBN | 1-118-84956-6 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Imaging technology assessment / Pari V. Pandharipande, G. Scott Gazelle -- Clinical trials of therapy / Sayeh Lavasani, Ali Mahinbakht, Anthony F. Shields -- Clinical trials of image guided interventions including radiotherapy studies / Gary S. Dorfman, Stephen M. Hahn -- Imaging as predictor of therapeutic response / David A. Mankoff, Anthony F. Shields -- Screening trials and design / Constance D. Lehman, Diana L. Miglioretti -- Practicalities of running a trial / Michael T. Lu, Elizabeth C. Adami, Udo Hoffmann -- Statistical issues in study design / Nancy A. Obuchowski -- Introduction to biostatistical methods / Diana L. Miglioretti, Todd A. Alonzo, Nancy A. Obuchowski -- Methods of studies of diagnostic tests / Jeffrey D. Blume -- Methods for quantitative imaging biomarker studies / Alicia Y. Toledano, Nancy A. Obuchowski -- Introduction to cost-effectiveness analysis in clinical trials / Ruth C. Carlos, G. Scott Gazelle. |
Record Nr. | UNINA-9910137400603321 |
Hoboken, New Jersey : , : Wiley Blackwell, , 2016 | ||
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Lo trovi qui: Univ. Federico II | ||
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Handbook for clinical trials of imaging and image-guided interventions / / edited by Nancy A. Obuchowski and G. Scott Gazelle |
Pubbl/distr/stampa | Hoboken, New Jersey : , : Wiley Blackwell, , 2016 |
Descrizione fisica | 1 online resource (226 p.) |
Disciplina | 616.07/54 |
Soggetto topico |
Diagnostic imaging
Clinical trials |
ISBN | 1-118-84956-6 |
Formato | Materiale a stampa ![]() |
Livello bibliografico | Monografia |
Lingua di pubblicazione | eng |
Nota di contenuto | Imaging technology assessment / Pari V. Pandharipande, G. Scott Gazelle -- Clinical trials of therapy / Sayeh Lavasani, Ali Mahinbakht, Anthony F. Shields -- Clinical trials of image guided interventions including radiotherapy studies / Gary S. Dorfman, Stephen M. Hahn -- Imaging as predictor of therapeutic response / David A. Mankoff, Anthony F. Shields -- Screening trials and design / Constance D. Lehman, Diana L. Miglioretti -- Practicalities of running a trial / Michael T. Lu, Elizabeth C. Adami, Udo Hoffmann -- Statistical issues in study design / Nancy A. Obuchowski -- Introduction to biostatistical methods / Diana L. Miglioretti, Todd A. Alonzo, Nancy A. Obuchowski -- Methods of studies of diagnostic tests / Jeffrey D. Blume -- Methods for quantitative imaging biomarker studies / Alicia Y. Toledano, Nancy A. Obuchowski -- Introduction to cost-effectiveness analysis in clinical trials / Ruth C. Carlos, G. Scott Gazelle. |
Record Nr. | UNINA-9910824682903321 |
Hoboken, New Jersey : , : Wiley Blackwell, , 2016 | ||
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Lo trovi qui: Univ. Federico II | ||
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