Design and analysis of bioavailability and bioequivalence studies / Shein-Chun Chow; Jen-pei Liu
Design of bioavailability studies -- Statistical inferences for effects from a standard 22 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intrasubject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges.
| Medienart: |
Buch |
|---|
| Erscheinungsjahr: |
2009 |
|---|---|
| Erschienen: |
Boca Raton, Fla. u.a.: Chapman & Hall/CRC ; 2009 |
| Ausgabe: |
3rd ed. |
| Reihe: |
|---|
| Sprache: |
Englisch |
|---|
| Beteiligte Personen: |
Chow, Shein-Chung, 1955- [VerfasserIn] |
|---|
| Links: |
|---|
| ISBN: |
|---|
| Nlm: |
2008 M-918 QV 38 |
|---|---|
| BKL: | |
| Themen: |
Bioavailability |
| RVK: |
|---|
| Anmerkungen: |
Includes bibliographical references and index |
|---|
| Umfang: |
XXII, 733 S. ; graph. Darst. |
|---|
| Weitere IDs: |
2008025461 |
|---|
| Förderinstitution / Projekttitel: |
|
|---|
| PPN (Katalog-ID): |
570472296 |
|---|
| LEADER | 01000cam a2200265 4500 | ||
|---|---|---|---|
| 001 | 570472296 | ||
| 003 | DE-627 | ||
| 005 | 20230911162250.0 | ||
| 007 | tu | ||
| 008 | 080626s2009 xxu||||| 00| ||eng c | ||
| 010 | |a 2008025461 | ||
| 020 | |a 9781584886686 |c hardback : alk. paper |9 978-1-58488-668-6 | ||
| 024 | 8 | |a 2008025461 |q Identnummer | |
| 035 | |a (DE-627)570472296 | ||
| 035 | |a (DE-576)287057151 | ||
| 035 | |a (DE-599)GBV570472296 | ||
| 035 | |a (OCoLC)730304061 | ||
| 035 | |a (OCoLC)166358489 | ||
| 035 | |a (ZBM)1158.62075 | ||
| 035 | |a (ZBM)1158.62075 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rakwb | ||
| 041 | |a eng | ||
| 044 | |c XD-US |c XA-GB | ||
| 050 | 0 | |a RM301.6 | |
| 060 | 0 | |a 2008 M-918 | |
| 060 | 0 | |a QV 38 | |
| 084 | |a 15,3 |2 ssgn | ||
| 084 | |a VX 8550 |2 rvk |0 (DE-625)rvk/147830:253 | ||
| 084 | |a SK 850 |2 rvk |0 (DE-625)rvk/143263: | ||
| 084 | |a VC 6000 |2 rvk |0 (DE-625)rvk/147080:253 | ||
| 084 | |a QH 252 |2 rvk |0 (DE-625)rvk/141562: | ||
| 084 | |a *62P10 |2 msc | ||
| 084 | |a 62-01 |2 msc | ||
| 084 | |a 92C45 |2 msc | ||
| 084 | |a 58.28 |2 bkl | ||
| 084 | |a 44.38 |2 bkl | ||
| 100 | 1 | |a Chow, Shein-Chung |d 1955- |e verfasserin |0 (DE-588)135557992 |0 (DE-627)567065529 |0 (DE-576)171782240 |4 aut | |
| 245 | 1 | 0 | |a Design and analysis of bioavailability and bioequivalence studies |c Shein-Chun Chow; Jen-pei Liu |
| 250 | |a 3rd ed. | ||
| 264 | 1 | |a Boca Raton, Fla. [u.a.] |b Chapman & Hall/CRC |c 2009 | |
| 300 | |a XXII, 733 S. |b graph. Darst. | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a ohne Hilfsmittel zu benutzen |b n |2 rdamedia | ||
| 338 | |a Band |b nc |2 rdacarrier | ||
| 490 | 1 | |a Chapman & Hall/CRC biostatistics series |v 27 | |
| 500 | |a Includes bibliographical references and index | ||
| 505 | 8 | 0 | |a Design of bioavailability studies -- Statistical inferences for effects from a standard 22 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intrasubject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges |
| 520 | |a Design of bioavailability studies -- Statistical inferences for effects from a standard 22 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intrasubject variabilities -- Assumptions of outlier detection for average bioequivalence -- Optimal crossover designs for two formulations for average bioequivalence -- Assessment of bioequivalence for more than two formulations -- Population and individual bioequivalence -- Statistical procedures for assessment of population and individual bioequivalence -- Assessment of bioequivalence for drugs with negligible plasma levels -- In vitro bioequivalence testing -- In vitro dissolution profiles comparison -- Meta-analysis for bioequivalence review -- Population pharmacokinetics -- Other pharmacokinetic studies -- Review of regulatory guidances on bioequivalence -- Frequently asked questions and future challenges | ||
| 583 | 1 | |a Archivierung prüfen |c 20200919 |f DE-640 |z 1 |2 pdager | |
| 650 | 0 | |a Bioavailability |x Research |x Statistical methods | |
| 650 | 0 | |a Drugs |x Therapeutic equivalency |x Research |x Statistical methods | |
| 650 | 0 | |a Bioavailability |x Research |x Statistical methods | |
| 650 | 0 | |a Drugs |x Therapeutic equivalency |x Research |x Statistical methods | |
| 650 | 0 | |a Biological Availability | |
| 650 | 0 | |a Statistics as Topic |x methods | |
| 650 | 0 | |a Therapeutic Equivalency | |
| 650 | 2 | |a Biological Availability | |
| 650 | 2 | |a Statistics as Topic |x methods | |
| 650 | 2 | |a Therapeutic Equivalency | |
| 689 | 0 | 0 | |D s |0 (DE-588)4145660-9 |0 (DE-627)105589470 |0 (DE-576)20974314X |a Bioverfügbarkeit |2 gnd |
| 689 | 0 | 1 | |D s |0 (DE-588)4031192-2 |0 (DE-627)106266888 |0 (DE-576)208991050 |a Klinische Prüfung |2 gnd |
| 689 | 0 | |5 (DE-627) | |
| 700 | 1 | |a Liu, Jen-Pei |d 1952- |0 (DE-588)172228549 |0 (DE-627)697140806 |0 (DE-576)133097757 |4 oth | |
| 830 | 0 | |a Chapman & Hall/CRC biostatistics series |v 27 |9 27 |w (DE-627)549837701 |w (DE-576)267469128 |w (DE-600)2397334-1 |7 ns | |
| 856 | 4 | 2 | |u https://zbmath.org/?q=an:1158.62075 |m B:ZBM |v 2021-04-12 |x Verlag |y Zentralblatt MATH |3 Inhaltstext |
| 856 | 4 | 2 | |u http://digitale-objekte.hbz-nrw.de/webclient/DeliveryManager?pid=2695024&custom_att_2=simple_viewer |x Verlag |3 Inhaltsverzeichnis |
| 912 | |a GBV_ILN_20 | ||
| 912 | |a ISIL_DE-84 | ||
| 912 | |a SYSFLAG_1 | ||
| 912 | |a GBV_KXP | ||
| 912 | |a SSG-OLC-PHA | ||
| 912 | |a SSG-OPC-MAT | ||
| 912 | |a SSG-OPC-PHA | ||
| 912 | |a SSG-OPC-DE-84 | ||
| 912 | |a GBV_ILN_40 | ||
| 912 | |a ISIL_DE-7 | ||
| 912 | |a GBV_ILN_40_i731 | ||
| 912 | |a GBV_ILN_2088 | ||
| 912 | |a ISIL_DE-Frei3c | ||
| 935 | |i Blocktest | ||
| 936 | r | v | |a VX 8550 |b Allgemeines |k Chemie und Pharmazie |k Pharmazeutische Technologie einschl. Biopharmazie |k Pharmazeutische Technologie allgemein |k Pharmakokinetik |k Allgemeines |0 (DE-627)1271728699 |0 (DE-625)rvk/147830:253 |0 (DE-576)201728699 |
| 936 | r | v | |a SK 850 |b Angewandte Statistik, Tabellen |k Mathematik |k Monografien |k Wahrscheinlichkeitstheorie |k Angewandte Statistik, Tabellen |0 (DE-627)1271156261 |0 (DE-625)rvk/143263: |0 (DE-576)201156261 |
| 936 | r | v | |a VC 6000 |b Allgemeines |k Chemie und Pharmazie |k Allgemeine Chemie; Mathematik, Statistik und Datenverarbeitung in Chemie und Pharmazie |k Mathematik, Statistik und Datenverarbeitung in Chemie und Pharmazie |k Mathematik für Chemiker |k Allgemeines |0 (DE-627)1271531801 |0 (DE-625)rvk/147080:253 |0 (DE-576)201531801 |
| 936 | r | v | |a QH 252 |b Biometrie, Lebensdaueranalyse (Survival analysis), Ereignisanalyse (event history analysis), Hazardratenmodelle |k Wirtschaftswissenschaften |k Mathematik. Statistik. Ökonometrie. Unternehmensforschung |k Statistik |k Sonstige Anwendungsgebiete der Statistik |k Biometrie, Lebensdaueranalyse (Survival analysis), Ereignisanalyse (event history analysis), Hazardratenmodelle |0 (DE-627)127157098X |0 (DE-625)rvk/141562: |0 (DE-576)20157098X |
| 936 | b | k | |a 58.28 |j Pharmazeutische Technologie |0 (DE-627)106417622 |
| 936 | b | k | |a 44.38 |j Pharmakologie |0 (DE-627)106409743 |
| 951 | |a BO | ||
| 953 | |2 045F |a 615/.7 | ||
| 953 | |2 045F |a 615.7 | ||
| 980 | |2 20 |1 01 |x 0084 |b 888207832 |c 00 |f LS2 |d PM B 952 |e b |j --%%-- |c 09 |f --%%-- |d 2884-6987 |e --%%-- |j --%%-- |y k |z 19-11-08 | ||
| 980 | |2 40 |1 01 |x 0007 |b 3929770105 |c 00 |f 7/731 |d Cho : MSB 1351 |e i |j --%%-- |y zi731 |z 20-05-21 | ||
| 980 | |2 2088 |1 01 |x DE-Frei3c |b 3195719304 |c 00 |f --%%-- |d M/Chow, S |e p |j --%%-- |y l01 |z 21-10-08 | ||
| 983 | |2 2088 |1 01 |x DE-Frei3c |8 00 |0 (DE-627)1295035014 |a AMS:62 |b Statistics | ||
| 983 | |2 2088 |1 01 |x DE-Frei3c |8 01 |0 (DE-627)1295439077 |a AMS:92 |b Biology and other natural sciences | ||
| 984 | |2 20 |1 01 |x 0084 |a 84$028846987 | ||
| 985 | |2 40 |1 01 |x 0007 |a MSB 1351 | ||
| 998 | |2 2088 |1 01 |x DE-Frei3c |0 20091 | ||