Info
Bioequivalence studies in drug development [[electronic resource] ] : methods and applications / / Dieter Hauschke, Volker Steinijans, Iris Pigeot
| Bioequivalence studies in drug development [[electronic resource] ] : methods and applications / / Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| Autore | Hauschke Dieter |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 |
| Descrizione fisica | 1 online resource (330 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) |
SteinijansVolker
PigeotIris |
| Collana | Statistics in practice |
| Soggetto topico | Drugs - Therapeutic equivalency |
| Soggetto genere / forma | Electronic books. |
| ISBN |
1-280-83880-9
9786610838806 0-470-09477-X 0-470-09476-1 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Bioequivalence Studies in Drug Development; Contents; Preface; 1 Introduction; 1.1 Definitions; 1.1.1 Bioavailability; 1.1.2 Bioequivalence; 1.1.3 Therapeutic equivalence; 1.2 When are bioequivalence studies performed; 1.2.1 Applications for products containing new active substances; 1.2.2 Applications for products containing approved active substances; 1.2.3 Applications for modified release forms essentially similar to a marketed modified release form; 1.3 Design and conduct of bioequivalence studies; 1.3.1 Crossover design and alternatives; 1.3.2 Single- vs. multiple-dose studies
1.3.3 Pharmacokinetic characteristics1.3.4 Subjects; 1.3.5 Statistical models; 1.3.5.1 Average bioequivalence; 1.3.5.2 Population bioequivalence; 1.3.5.3 Individual bioequivalence; 1.3.6 Sample size; 1.4 Aims and structure of the book; References; 2 Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies; 2.1 Introduction; 2.2 Pharmacokinetic characteristics (metrics) for single-dose studies; 2.2.1 Extent of bioavailability; 2.2.2 Rate of bioavailability; 2.3 Pharmacokinetic rate and extent characteristics (metrics) for multiple-dose studies 2.4 ConclusionsReferences; 3 Basic statistical considerations; 3.1 Introduction; 3.2 Additive and multiplicative model; 3.2.1 The normal distribution; 3.2.2 The lognormal distribution; 3.3 Hypotheses testing; 3.3.1 Consumer and producer risk; 3.3.2 Types of hypotheses; 3.3.2.1 Test for difference; 3.3.2.2 Test for superiority; 3.3.2.3 Test for noninferiority; 3.3.2.4 Test for equivalence; 3.3.3 Difference versus ratio of expected means; 3.3.3.1 The normal distribution; 3.3.3.2 The lognormal distribution; 3.4 The RT/TR crossover design assuming an additive model 3.4.1 Additive model and effects3.4.2 Parametric analysis based on t-tests; 3.4.2.1 Test for difference in carryover effects; 3.4.2.2 Test for difference in formulation effects; 3.4.2.3 Test for difference in period effects; 3.4.3 Nonparametric analysis based on Wilcoxon rank sum tests; 3.4.3.1 Test for difference in carryover effects; 3.4.3.2 Test for difference in formulation effects; 3.4.3.3 Test for difference in period effects; References; 4 Assessment of average bioequivalence in the RT/TR design; 4.1 Introduction; 4.2 The RT/TR crossover design assuming a multiplicative model 5 Power and sample size determination for testing average bioequivalence in the RT/TR design |
| Record Nr. | UNINA-9910143714303321 |
Hauschke Dieter
|
||
| Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Bioequivalence studies in drug development [[electronic resource] ] : methods and applications / / Dieter Hauschke, Volker Steinijans, Iris Pigeot
| Bioequivalence studies in drug development [[electronic resource] ] : methods and applications / / Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| Autore | Hauschke Dieter |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 |
| Descrizione fisica | 1 online resource (330 p.) |
| Disciplina |
615.19
615/.19 |
| Altri autori (Persone) |
SteinijansVolker
PigeotIris |
| Collana | Statistics in practice |
| Soggetto topico | Drugs - Therapeutic equivalency |
| ISBN |
1-280-83880-9
9786610838806 0-470-09477-X 0-470-09476-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Bioequivalence Studies in Drug Development; Contents; Preface; 1 Introduction; 1.1 Definitions; 1.1.1 Bioavailability; 1.1.2 Bioequivalence; 1.1.3 Therapeutic equivalence; 1.2 When are bioequivalence studies performed; 1.2.1 Applications for products containing new active substances; 1.2.2 Applications for products containing approved active substances; 1.2.3 Applications for modified release forms essentially similar to a marketed modified release form; 1.3 Design and conduct of bioequivalence studies; 1.3.1 Crossover design and alternatives; 1.3.2 Single- vs. multiple-dose studies
1.3.3 Pharmacokinetic characteristics1.3.4 Subjects; 1.3.5 Statistical models; 1.3.5.1 Average bioequivalence; 1.3.5.2 Population bioequivalence; 1.3.5.3 Individual bioequivalence; 1.3.6 Sample size; 1.4 Aims and structure of the book; References; 2 Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies; 2.1 Introduction; 2.2 Pharmacokinetic characteristics (metrics) for single-dose studies; 2.2.1 Extent of bioavailability; 2.2.2 Rate of bioavailability; 2.3 Pharmacokinetic rate and extent characteristics (metrics) for multiple-dose studies 2.4 ConclusionsReferences; 3 Basic statistical considerations; 3.1 Introduction; 3.2 Additive and multiplicative model; 3.2.1 The normal distribution; 3.2.2 The lognormal distribution; 3.3 Hypotheses testing; 3.3.1 Consumer and producer risk; 3.3.2 Types of hypotheses; 3.3.2.1 Test for difference; 3.3.2.2 Test for superiority; 3.3.2.3 Test for noninferiority; 3.3.2.4 Test for equivalence; 3.3.3 Difference versus ratio of expected means; 3.3.3.1 The normal distribution; 3.3.3.2 The lognormal distribution; 3.4 The RT/TR crossover design assuming an additive model 3.4.1 Additive model and effects3.4.2 Parametric analysis based on t-tests; 3.4.2.1 Test for difference in carryover effects; 3.4.2.2 Test for difference in formulation effects; 3.4.2.3 Test for difference in period effects; 3.4.3 Nonparametric analysis based on Wilcoxon rank sum tests; 3.4.3.1 Test for difference in carryover effects; 3.4.3.2 Test for difference in formulation effects; 3.4.3.3 Test for difference in period effects; References; 4 Assessment of average bioequivalence in the RT/TR design; 4.1 Introduction; 4.2 The RT/TR crossover design assuming a multiplicative model 5 Power and sample size determination for testing average bioequivalence in the RT/TR design |
| Record Nr. | UNINA-9910830433203321 |
|
Hauschke Dieter
|
||
| Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Bioequivalence studies in drug development : methods and applications / / Dieter Hauschke, Volker Steinijans, Iris Pigeot
| Bioequivalence studies in drug development : methods and applications / / Dieter Hauschke, Volker Steinijans, Iris Pigeot |
| Autore | Hauschke Dieter |
| Pubbl/distr/stampa | Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 |
| Descrizione fisica | 1 online resource (330 p.) |
| Disciplina | 615/.19 |
| Altri autori (Persone) |
SteinijansVolker
PigeotIris |
| Collana | Statistics in practice |
| Soggetto topico | Drugs - Therapeutic equivalency |
| ISBN |
9786610838806
9781280838804 1280838809 9780470094778 047009477X 9780470094761 0470094761 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Bioequivalence Studies in Drug Development; Contents; Preface; 1 Introduction; 1.1 Definitions; 1.1.1 Bioavailability; 1.1.2 Bioequivalence; 1.1.3 Therapeutic equivalence; 1.2 When are bioequivalence studies performed; 1.2.1 Applications for products containing new active substances; 1.2.2 Applications for products containing approved active substances; 1.2.3 Applications for modified release forms essentially similar to a marketed modified release form; 1.3 Design and conduct of bioequivalence studies; 1.3.1 Crossover design and alternatives; 1.3.2 Single- vs. multiple-dose studies
1.3.3 Pharmacokinetic characteristics1.3.4 Subjects; 1.3.5 Statistical models; 1.3.5.1 Average bioequivalence; 1.3.5.2 Population bioequivalence; 1.3.5.3 Individual bioequivalence; 1.3.6 Sample size; 1.4 Aims and structure of the book; References; 2 Metrics to characterize concentration-time profiles in single- and multiple-dose bioequivalence studies; 2.1 Introduction; 2.2 Pharmacokinetic characteristics (metrics) for single-dose studies; 2.2.1 Extent of bioavailability; 2.2.2 Rate of bioavailability; 2.3 Pharmacokinetic rate and extent characteristics (metrics) for multiple-dose studies 2.4 ConclusionsReferences; 3 Basic statistical considerations; 3.1 Introduction; 3.2 Additive and multiplicative model; 3.2.1 The normal distribution; 3.2.2 The lognormal distribution; 3.3 Hypotheses testing; 3.3.1 Consumer and producer risk; 3.3.2 Types of hypotheses; 3.3.2.1 Test for difference; 3.3.2.2 Test for superiority; 3.3.2.3 Test for noninferiority; 3.3.2.4 Test for equivalence; 3.3.3 Difference versus ratio of expected means; 3.3.3.1 The normal distribution; 3.3.3.2 The lognormal distribution; 3.4 The RT/TR crossover design assuming an additive model 3.4.1 Additive model and effects3.4.2 Parametric analysis based on t-tests; 3.4.2.1 Test for difference in carryover effects; 3.4.2.2 Test for difference in formulation effects; 3.4.2.3 Test for difference in period effects; 3.4.3 Nonparametric analysis based on Wilcoxon rank sum tests; 3.4.3.1 Test for difference in carryover effects; 3.4.3.2 Test for difference in formulation effects; 3.4.3.3 Test for difference in period effects; References; 4 Assessment of average bioequivalence in the RT/TR design; 4.1 Introduction; 4.2 The RT/TR crossover design assuming a multiplicative model 5 Power and sample size determination for testing average bioequivalence in the RT/TR design |
| Record Nr. | UNINA-9911019528803321 |
|
Hauschke Dieter
|
||
| Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Digital Public Health : Interdisciplinary Perspectives
| Digital Public Health : Interdisciplinary Perspectives |
| Autore | Zeeb Hajo |
| Edizione | [1st ed.] |
| Pubbl/distr/stampa | Cham : , : Springer, , 2025 |
| Descrizione fisica | 1 online resource (801 pages) |
| Altri autori (Persone) |
MaaßLaura
SchultzTanja HaugUlrike PigeotIris SchüzBenjamin |
| Collana | Springer Series on Epidemiology and Public Health Series |
| ISBN | 3-031-90154-1 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Record Nr. | UNINA-9911022459503321 |
|
Zeeb Hajo
|
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| Cham : , : Springer, , 2025 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Handbook of Epidemiology / / edited by Wolfgang Ahrens, Iris Pigeot
| Handbook of Epidemiology / / edited by Wolfgang Ahrens, Iris Pigeot |
| Edizione | [2nd ed. 2014.] |
| Pubbl/distr/stampa | New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 |
| Descrizione fisica | 1 online resource (XXX, 2498 p. 280 illus., 24 illus. in color. eReference.) |
| Disciplina | 614.4 |
| Soggetto topico |
Epidemiology
Biometry Medical sciences Biostatistics Health Sciences |
| ISBN |
1-78539-592-0
0-387-09834-8 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | Foreword -- Preface -- Part I: Concepts and Designs in Epidemiology; An Introduction to Epidemiology, History of Epidemiological Methods and Concepts (NEW), Basic Concepts, Rates, Risks, Measures of Association and Impact, Descriptive Studies, Cohort Studies, Case-Control Studies, Modern Epidemiological Study Designs, Intervention Trials, Cluster Randomized Trials (NEW), Community-Based Health Promotion, Internet Based Epidemiology (NEW) -- Part II: Methodological Approaches in Epidemiology; Design and Planning of Epidemiological Studies, Quality Control and Good Epidemiological Practice, Epidemiological Field Work in Population-Based Studies, Exposure Assessment, Misclassification (NEW), Confounding and Interaction, Sensitivity Analysis and Bias Analysis (NEW), Use of Health Registers, Emergency and Disaster Health Surveillance (NEW), Screening, Epidemiology in Developing Countries, Health Services Research, Ethical Aspects of Epidemiological Research -- Part III: Statistical Methodsin Epidemiology; Statistical Inference (NEW), Data Management in Epidemiology (NEW), Sample Size Determination in Epidemiological Studies, Analysis of Continuous Covariates and Dose-Effect Analysis, Regression Methods for Epidemiological Analysis, Bayesian Methods in Epidemiology (NEW), Survival Analysis, Measurement Error, Missing Data, Generalized Estimating Equations (NEW), Meta-Analysis in Epidemiology, Geographical Epidemiology, Statistical Methods in Genetic Epidemiology, Directed Acyclic Graphs (NEW) -- Part IV: Exposure-oriented Epidemiology; Life Course Epidemiology (NEW), Social Epidemiology, Occupational Epidemiology, Environmental Epidemiology, Nutritional Epidemiology, Reproductive Epidemiology, Molecular Epidemiology, Clinical Epidemiology of Evidence-Based Health Care, Pharmacoepidemiology, Physical Activity Epidemiology (NEW), Radiation Epidemiology (NEW) -- Part V: Outcome-oriented Epidemiology; Infectious Disease Epidemiology, Cardiovascular Health and Disease, CancerEpidemiology, Musculoskeletal Disorders, Epidemiology of Obesity (NEW), Epidemiology of Respiratory Allergies and Asthma (NEW), Epidemiology of Dental Diseases (NEW), Epidemiology of Digestive Diseases (NEW), Epidemiology of Psychiatric Disorders (NEW), Epidemiology of Diabetes (NEW). |
| Record Nr. | UNINA-9910300357603321 |
| New York, NY : , : Springer New York : , : Imprint : Springer, , 2014 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Instruments for Health Surveys in Children and Adolescents / / edited by Karin Bammann, Lauren Lissner, Iris Pigeot, Wolfgang Ahrens
| Instruments for Health Surveys in Children and Adolescents / / edited by Karin Bammann, Lauren Lissner, Iris Pigeot, Wolfgang Ahrens |
| Edizione | [1st ed. 2019.] |
| Pubbl/distr/stampa | Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 |
| Descrizione fisica | XVI, 301 p. : gráf. ; ; 25 cm |
| Disciplina | 614.42 |
| Collana | Springer Series on Epidemiology and Public Health |
| Soggetto topico |
Statistics
Epidemiology Health promotion Diet therapy Clinical health psychology Statistics for Life Sciences, Medicine, Health Sciences Health Promotion and Disease Prevention Clinical Nutrition Statistics for Social Sciences, Humanities, Law Health Psychology |
| ISBN | 3-319-98857-3 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto | 0 Preface -- 1 The IDEFICS/I.Family studies: design and methods of a large European child cohort -- 2 MODYS – a modular control and documentation system for epidemiological studies -- 3 Physical examinations -- 4 Biological samples – Standard Operating Procedures for collection, shipment, storage and documentation -- 5 Web-based 24-Hour Dietary Recall: the SACANA program -- 6 Dietary behaviour in children, adolescents and families: the Eating Habits Questionnaire (EHQ) -- 7 Accelerometry-based physical activity assessment for children and adolescents -- 8 Pre- and post-natal factors obtained from health records -- 9 Core questionnaires -- 10 Instruments for assessing the role of commercials on children’s food choices -- 11 Process evaluation of the IDEFICS intervention -- 12 Assessment of sensory taste perception in children -- 13 Physical fitness -- 14 Interview on kinship and household. |
| Record Nr. | UNINA-9910337486503321 |
| Cham : , : Springer International Publishing : , : Imprint : Springer, , 2019 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Statistik : Der Weg zur Datenanalyse / / von Ludwig Fahrmeir, Christian Heumann, Rita Künstler, Iris Pigeot, Gerhard Tutz
| Statistik : Der Weg zur Datenanalyse / / von Ludwig Fahrmeir, Christian Heumann, Rita Künstler, Iris Pigeot, Gerhard Tutz |
| Autore | Fahrmeir Ludwig |
| Edizione | [8th ed. 2016.] |
| Pubbl/distr/stampa | Berlin, Heidelberg : , : Springer Berlin Heidelberg : , : Imprint : Springer Spektrum, , 2016 |
| Descrizione fisica | 1 online resource (XVI, 581 S. 162 Abb.) |
| Disciplina | 519.5 |
| Collana | Springer-Lehrbuch |
| Soggetto topico |
Statistics
Econometrics Statistical Theory and Methods Statistics in Business, Management, Economics, Finance, Insurance Quantitative Economics |
| ISBN | 3-662-50372-7 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | ger |
| Nota di contenuto | Einführung -- Univariate Deskription und Exploration von Daten -- Multivariate Deskription und Exploration -- Wahrscheinlichkeitsrechnung -- Diskrete Zufallsvariablen -- Stetige Zufallsvariablen -- Mehr über Zufallsvariablen und Verteilungen -- Mehrdimensionale Zufallsvariablen -- Parameterschätzung -- Testen von Hypothesen -- Spezielle Testprobleme -- Regressionsanalyse -- Varianzanalyse -- Zeitreihen -- Einführung in R. |
| Record Nr. | UNINA-9910483321803321 |
|
Fahrmeir Ludwig
|
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| Berlin, Heidelberg : , : Springer Berlin Heidelberg : , : Imprint : Springer Spektrum, , 2016 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||