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Approved drug products with therapeutic equivalence evaluations
| Approved drug products with therapeutic equivalence evaluations |
| Pubbl/distr/stampa | [Rockville, Md.], : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics |
| Descrizione fisica | 1 online resource (volumes) |
| Disciplina |
615
615/.1 |
| Soggetto topico |
Drugs - Therapeutic equivalency
Drugs - Bioavailability Drugs Pharmaceutical services insurance Medical care - United States Medical care Pharmaceutical Preparations Therapeutic Equivalency |
| Soggetto genere / forma |
Catalogs.
Periodicals. Catalog Periodical |
| ISSN | 2158-7744 |
| Formato | Materiale a stampa  |
| Livello bibliografico | Periodico |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Orange book |
| Record Nr. | UNINA-9910132234103321 |
| [Rockville, Md.], : U.S. Dept. of Health and Human Services, Public Health Service, Food and Drug Administration, Center for Drugs and Biologics | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Arzneimitteltherapiesicherheit im spannungsfeld von vollständiger nedikationsübersicht, mündigem Patienten und individualisierter Medikation / / Alexandra Classen [and sixteen others]
| Arzneimitteltherapiesicherheit im spannungsfeld von vollständiger nedikationsübersicht, mündigem Patienten und individualisierter Medikation / / Alexandra Classen [and sixteen others] |
| Pubbl/distr/stampa | Göttingen, [Germany] : , : Cuvillier Verlag, , 2015 |
| Descrizione fisica | 1 online resource (144 pages) |
| Disciplina | 615.19 |
| Collana | Sozialwissenschaftliche Ansätze in der Wirtschaftsinformatik |
| Soggetto topico | Drugs - Therapeutic equivalency |
| ISBN | 3-7369-8115-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | ger |
| Record Nr. | UNINA-9910794964803321 |
| Göttingen, [Germany] : , : Cuvillier Verlag, , 2015 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Arzneimitteltherapiesicherheit im spannungsfeld von vollständiger nedikationsübersicht, mündigem Patienten und individualisierter Medikation / / Alexandra Classen [and sixteen others]
| Arzneimitteltherapiesicherheit im spannungsfeld von vollständiger nedikationsübersicht, mündigem Patienten und individualisierter Medikation / / Alexandra Classen [and sixteen others] |
| Pubbl/distr/stampa | Göttingen, [Germany] : , : Cuvillier Verlag, , 2015 |
| Descrizione fisica | 1 online resource (144 pages) |
| Disciplina | 615.19 |
| Collana | Sozialwissenschaftliche Ansätze in der Wirtschaftsinformatik |
| Soggetto topico | Drugs - Therapeutic equivalency |
| ISBN | 3-7369-8115-5 |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | ger |
| Record Nr. | UNINA-9910826759203321 |
| Göttingen, [Germany] : , : Cuvillier Verlag, , 2015 | ||
| 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 |
| 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-9910876806603321 |
|
Hauschke Dieter
|
||
| Chichester, West Sussex, England ; ; Hoboken, NJ, : Wiley, c2007 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
| Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
| Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica | 1 online resource (292 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
| Collana | Drugs and the pharmaceutical sciences |
| Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
| Soggetto genere / forma | Electronic books. |
| ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products - Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products - Manufacture and Quality ; Index; Color Insert ; Back Cover |
| Record Nr. | UNINA-9910459270503321 |
| New York : , : Informa Healthcare USA, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
| Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
| Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica | 1 online resource (292 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
| Collana | Drugs and the pharmaceutical sciences |
| Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
| ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products - Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products - Manufacture and Quality ; Index; Color Insert ; Back Cover |
| Record Nr. | UNINA-9910792350103321 |
| New York : , : Informa Healthcare USA, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer
| Generic drug product development : specialty dosage forms / / edited by Leon Shargel, Isadore Kanfer |
| Pubbl/distr/stampa | New York : , : Informa Healthcare USA, , 2010 |
| Descrizione fisica | 1 online resource (292 p.) |
| Disciplina | 615.19 |
| Altri autori (Persone) |
ShargelLeon <1941->
KanferIsadore |
| Collana | Drugs and the pharmaceutical sciences |
| Soggetto topico |
Generic drugs
Drug development Drugs - Dosage forms Drugs - Therapeutic equivalency |
| ISBN |
0-429-13292-1
1-282-56098-0 9786612560989 1-4200-2003-X |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Nota di contenuto |
Front Cover; Preface; Contents; Chapter 1. Introduction; Chapter 2. Nonsystemically Absorbed Oral Drug Products; Chapter 3. Topical Drug Products - Development, Manufacture, and Regulatory Issues; Chapter 4. Assessment of Topical Dosage Forms Intended for Local or Regional Activity; Chapter 5. Rectal Dosage Forms and Suppositories; Chapter 6. Nasal and INhalation Drug Products; Chapter 7. Locally Acting Nasal and inhalation Drug Products: Regulatory and Bioequivalence Perspective; Chapter 8. Transdermal Dosage Forms
Chapter 9. Pharmaceutical Development of Modified-Release Parenteral Dosage Forms Using Bioequivalence (BE), Quality by Design (QBD), and In Vitro In Vitro Correlation (IVIVC) Principles Chapter 10. Biosimilar Drug Products - Manufacture and Quality ; Index; Color Insert ; Back Cover |
| Record Nr. | UNINA-9910800062003321 |
| New York : , : Informa Healthcare USA, , 2010 | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
Guidance for industry [[electronic resource] ] : food-effect bioavailability and fed bioequivalence studies
| Guidance for industry [[electronic resource] ] : food-effect bioavailability and fed bioequivalence studies |
| Pubbl/distr/stampa | Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2002] |
| Descrizione fisica | 1 online resource (9 pages) |
| Soggetto topico |
Drugs - Bioavailability
Drugs - Therapeutic equivalency |
| Formato | Materiale a stampa |
| Livello bibliografico | Monografia |
| Lingua di pubblicazione | eng |
| Altri titoli varianti | Guidance for industry |
| Record Nr. | UNINA-9910699059003321 |
| Rockville, MD : , : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, , [2002] | ||
| Materiale a stampa | ||
| Lo trovi qui: Univ. Federico II | ||
| ||
