| Description |
1 online resource (xxi, 374 pages) : illustrations |
| Series |
Chapman & Hall/CRC interdisciplinary statistics series |
|
Interdisciplinary statistics.
|
| Contents |
DRUG DEVELOPMENT AND CLINICAL PHARMACOLOGY; Aims of This Book; Drug Development; Clinical Pharmacology; Statistics in Clinical Pharmacology; Structure of the Book; ; HISTORY AND REGULATION OF BIOEQUIVALENCE; When and How BE Studies Are Performed; Why Are BE Studies Performed?; Deciding When Formulations Are Bioequivalent; Potential Issues with TOST Bioequivalence; Current International Regulation; ; TESTING FOR AVERAGE BIOEQUIVALENCE; Background; Linear Model for 2 x 2 Data; Applying the TOST Procedure; Carry-over, Sequence, |
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And Interaction Effects; Checking Assumptions Made about the Linear Model; Power and Sample Size for ABE in the 2 x 2 Design; Example Where Test and Reference Are Not ABE; Nonparametric Analysis; Some Practical Issues; ; BE STUDIES WITH MORE THAN TWO PERIODS; Background; Three-period Designs; Within-subject Variability; Robust Analyses for Three Period Designs; Four-Period Designs; Designs with More than Two Treatments; Nonparametric Analyses of Tmax; Technical Appendix: Efficiency; Tables of Data; ; DEALING WITH UNEXPECTED BE CHALLENGES; Restricted Maximum Likelihood Modelling; Failing BE and the DER Assessment; Simulation; Data-Based Simulation; Carry-Over; Optional Designs; Determining Trial Size; What Outliers are and How to Handle Their Data; Bayesian BE Assessment; Technical Appendix; ; THE FUTURE AND RECENT PAST OF BE TESTING; Brief History; Individual and Population BE; Scaled Average BE; ; CLINICAL |
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PHARMACOLOGY SAFETY STUDIES; Background; First-time-in-humans; Sub-chronic Dosing Studies; Food-Effect Assessment and DDIs; Dose-Proportionality; Technical Appendix; ; QTC; Background; Modelling of QTc Data; Interpreting the QTc Modelling Findings; Design of a Thorough QTc Study in the Future; Technical Appendix; ; CLINICAL PHARMACOLOGY EFFICACY STUDIES; Background; Sub-chronic Dosing; Phase IIa and the Proof of Concept; Methodology Studies; ; POPULATION PHARMACOKINETICS; Population and Pharmacokinetics; Absolute and Relative Bioavailability; Age and Gender Pharmacokinetic Studies; Ethnicity; Liver Disease; Kidney Disease; Technical Appendix; ; Epilogue; Bibliography; Index |
| Bibliography |
Includes bibliographical references (pages 335-370) and index |
| Notes |
Print version record |
| Subject |
Clinical pharmacology.
|
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Drugs -- Therapeutic equivalency.
|
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Medical statistics.
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Pharmacology, Clinical
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Therapeutic Equivalency
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Statistics
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MEDICAL -- Drug Guides.
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MEDICAL -- Pharmacology.
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MEDICAL -- Pharmacy.
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MEDICAL -- Nursing -- Pharmacology.
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Clinical pharmacology
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Drugs -- Therapeutic equivalency
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Medical statistics
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| Form |
Electronic book
|
| Author |
Jones, Byron, 1951-
|
| LC no. |
2005053753 |
| ISBN |
1420034936 |
|
9781420034936 |
|
1584885300 |
|
9781584885306 |
|
