Bioequivalence and Statistics in Clinical PharmacologyCRC Press, 10. nov. 2005 - 400 sider Maintaining a practical perspective, Bioequivalence and Statistics in Clinical Pharmacology explores statistics used in day-to-day clinical pharmacology work. The book covers the methods needed to design, analyze, and interpret bioequivalence trials; explores when, how, and why these studies are performed as part of drug development; and demonstrat |
Innhold
Drug Development and Clinical Pharmacology | 1 |
History and Regulation of Bioequivalence | 17 |
Testing for Average Bioequivalence | 39 |
BE Studies with More Than Two Periods | 79 |
Dealing with Unexpected BE Challenges | 133 |
The Future and Recent Past of BE Testing | 177 |
Clinical Pharmacology Safety Studies | 189 |
QTc | 243 |
Clinical Pharmacology Efficacy Studies | 269 |
Population Pharmacokinetics | 299 |
Epilogue | 333 |
Bibliography | 335 |
| 371 | |
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Bioequivalence and Statistics in Clinical Pharmacology Scott D. Patterson,Byron Jones Ingen forhåndsvisning tilgjengelig - 2005 |
Vanlige uttrykk og setninger
adjusted alternative analysis applied approach assessment assume AUC and Cmax bioavailability bioequivalence bootstrap calculate carry-over changes Chapter clinical pharmacology comparison concentration confidence interval cross-over data set demonstrate denotes derived described determine difference discussed distribution dose drug development drug product effects efficacy endpoints equivalence error estimate evidence Example expected exposure Figure findings formulation given Group guidance half-life healthy impact included increased individual interaction interest Journal limits logAUC logCmax lower mean measure methods normal Note observed parameters patients performed Period pharmacokinetic Phase placebo Plot population potential practical precision probability proc mixed procedure prolongation random reference regimen regulatory relative repeated response safety sample scale Sequence similar standard statistical Study Design Table testing therapeutic TOST treatment trials Type values variability variance versus within-subject
Populære avsnitt
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