Bioequivalence Studies in Drug Development : Methods and Applications
Dieter. Hauschke
Bok Engelsk 2007 · Electronic books.
| Annen tittel | |
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| Utgitt | Hoboken : : Wiley, , 2007.
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| Omfang | 1 online resource (330 p.)
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| Opplysninger | Description based upon print version of record.. - 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. - 4.2.1 Multiplicative model and effects4.2.2 Test problem; 4.2.3 Estimation of the formulation difference; 4.3 Test procedures for bioequivalence assessment; 4.3.1 Analysis of variance; 4.3.1.1 Example: Dose equivalence study; 4.3.2 Two one-sided t-tests and (1 - 2α)100 % confidence interval; 4.3.2.1 Example: Dose equivalence study; 4.3.3 Two one-sided Wilcoxon rank sum tests and (1−2α)100 % confidence interval; 4.3.3.1 Example: Dose equivalence study; 4.3.3.2 Analysis of time to maximum concentration; 4.3.4 Bioequivalence ranges; 4.4 Conclusions; References. - 5 Power and sample size determination for testing average bioequivalence in the RT/TR design. - Studies in bioequivalence are the commonly accepted method to demonstrate therapeutic equivalence between two medicinal products. Savings in time and cost are substantial when using bioequivalence as an established surrogate marker of therapeutic equivalence. For this reason the design, performance and evaluation of bioequivalence studies have received major attention from academia, the pharmaceutical industry and health authorities. Bioequivalence Studies in Drug Development focuses on the planning, conducting, analysing and reporting of bioequivalence studies, covering all aspects r
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| Emner | Drugs - Therapeutic equivalency
Analytical, Diagnostic and Therapeutic Techniques and Equipment Biological Science Disciplines Chemistry Vis mer... Chemistry, Pharmaceutical
Clinical Trials as Topic Disciplines and Occupations Drug Discovery Environment and Public Health Epidemiologic Methods Epidemiologic Study Characteristics as Topic Evaluation Studies as Topic Health Care Health Care Evaluation Mechanisms Health Care Quality, Access, and Evaluation Investigative Techniques Metabolic Phenomena Methods Models, Statistical Models, Theoretical Natural Science Disciplines Pharmacokinetics Pharmacological Phenomena Pharmacology Phenomena and Processes Physiological Phenomena Public Health Quality of Health Care Statistics as Topic Clinical Trials - methods. Drug Design. Therapeutic Equivalency. Health & Biological Sciences Pharmacy, Therapeutics, & Pharmacology |
| Sjanger | |
| Dewey | |
| ISBN | 0470094753. - 9780470094754
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