Design and analysis of bioavailability and bioequivalence studies:
Saved in:
| Main Authors: | , |
|---|---|
| Format: | Book |
| Language: | English |
| Published: |
New York u.a.
Dekker
2000
|
| Edition: | 2. ed., rev. and expanded |
| Series: | Biostatistics
3 |
| Subjects: | |
| Online Access: | Inhaltsverzeichnis |
| Physical Description: | XII, 584 S. graph. Darst. |
| ISBN: | 0824775724 |
Staff View
MARC
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| 100 | 1 | |a Chow, Shein-Chung |e Verfasser |4 aut | |
| 245 | 1 | 0 | |a Design and analysis of bioavailability and bioequivalence studies |c Shein-Chung Chow ; Jen-Pei Liu |
| 250 | |a 2. ed., rev. and expanded | ||
| 264 | 1 | |a New York u.a. |b Dekker |c 2000 | |
| 300 | |a XII, 584 S. |b graph. Darst. | ||
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| 490 | 1 | |a Biostatistics |v 3 | |
| 650 | 4 | |a Statistik | |
| 650 | 4 | |a Bioavailability |x Research |x Statistical methods | |
| 650 | 4 | |a Biological Availability | |
| 650 | 4 | |a Drugs |x Therapeutic equivalency |x Research |x Statistical methods | |
| 650 | 4 | |a Statistics as Topic |x methods | |
| 650 | 4 | |a Therapeutic Equivalency | |
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Record in the Search Index
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Contents
Series Introduction Hi
Preface v
Preface to the First Edition vii
i 1. Introduction 1
2. Designs of Bioavailability Studies 31
3. Statistical Inferences for Effects from a Standard
2x2 Crossover Design 57
4. Statistical Methods for Average Bioavailability 79
5. Power and Sample Size Determination 125
6. Transformation and Analysis of Individual Subject Ratios 161
7. The Assessment of Inter and Intrasubject Variabilities 187
f
8. Assumptions and Outliers Detection 221
9. Optimal Crossover Designs for Two Formulations 257
10. Assessment of Bioequivalence for More Than
Two Formulations 303
11. Assessment of Bioequivalence for Drugs with Negligible
f Plasma Levels 333
12. Some Related Problems in Bioavailability Studies 361
13. Meta Analysis for Bioequivalence Review 379
xi
xii Contents
14. Population and Individual Bioequivalence 401
15. Statistical Procedures for Assessment of Population
and Individual Bioequivalence 443
16. Review of FDA Guidances 489
References 521
Appendix A: Statistical Tables 537
Appendix B: SAS Programs 557
Index 577
|
| any_adam_object | 1 |
| author | Chow, Shein-Chung Liu, Jen-Pei |
| author_facet | Chow, Shein-Chung Liu, Jen-Pei |
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| bvnumber | BV013101405 |
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| callnumber-label | RM301 |
| callnumber-raw | RM301.6 |
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| callnumber-subject | RM - Therapeutics and Pharmacology |
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| ctrlnum | (OCoLC)42690028 (DE-599)BVBBV013101405 |
| dewey-full | 615/.7 |
| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 615 - Pharmacology and therapeutics |
| dewey-raw | 615/.7 |
| dewey-search | 615/.7 |
| dewey-sort | 3615 17 |
| dewey-tens | 610 - Medicine and health |
| discipline | Chemie / Pharmazie Medizin |
| edition | 2. ed., rev. and expanded |
| format | Book |
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| id | DE-604.BV013101405 |
| illustrated | Illustrated |
| indexdate | 2024-07-09T18:39:04Z |
| institution | BVB |
| isbn | 0824775724 |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-008924604 |
| oclc_num | 42690028 |
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| physical | XII, 584 S. graph. Darst. |
| publishDate | 2000 |
| publishDateSearch | 2000 |
| publishDateSort | 2000 |
| publisher | Dekker |
| record_format | marc |
| series | Biostatistics |
| series2 | Biostatistics |
| spelling | Chow, Shein-Chung Verfasser aut Design and analysis of bioavailability and bioequivalence studies Shein-Chung Chow ; Jen-Pei Liu 2. ed., rev. and expanded New York u.a. Dekker 2000 XII, 584 S. graph. Darst. txt rdacontent n rdamedia nc rdacarrier Biostatistics 3 Statistik Bioavailability Research Statistical methods Biological Availability Drugs Therapeutic equivalency Research Statistical methods Statistics as Topic methods Therapeutic Equivalency Statistik (DE-588)4056995-0 gnd rswk-swf Bioverfügbarkeit (DE-588)4145660-9 gnd rswk-swf Bioäquivalenz (DE-588)4204145-4 gnd rswk-swf Bioverfügbarkeit (DE-588)4145660-9 s Statistik (DE-588)4056995-0 s DE-604 Bioäquivalenz (DE-588)4204145-4 s Liu, Jen-Pei Verfasser aut Biostatistics 3 (DE-604)BV013101415 3 HBZ Datenaustausch application/pdf http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008924604&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA Inhaltsverzeichnis |
| spellingShingle | Chow, Shein-Chung Liu, Jen-Pei Design and analysis of bioavailability and bioequivalence studies Biostatistics Statistik Bioavailability Research Statistical methods Biological Availability Drugs Therapeutic equivalency Research Statistical methods Statistics as Topic methods Therapeutic Equivalency Statistik (DE-588)4056995-0 gnd Bioverfügbarkeit (DE-588)4145660-9 gnd Bioäquivalenz (DE-588)4204145-4 gnd |
| subject_GND | (DE-588)4056995-0 (DE-588)4145660-9 (DE-588)4204145-4 |
| title | Design and analysis of bioavailability and bioequivalence studies |
| title_auth | Design and analysis of bioavailability and bioequivalence studies |
| title_exact_search | Design and analysis of bioavailability and bioequivalence studies |
| title_full | Design and analysis of bioavailability and bioequivalence studies Shein-Chung Chow ; Jen-Pei Liu |
| title_fullStr | Design and analysis of bioavailability and bioequivalence studies Shein-Chung Chow ; Jen-Pei Liu |
| title_full_unstemmed | Design and analysis of bioavailability and bioequivalence studies Shein-Chung Chow ; Jen-Pei Liu |
| title_short | Design and analysis of bioavailability and bioequivalence studies |
| title_sort | design and analysis of bioavailability and bioequivalence studies |
| topic | Statistik Bioavailability Research Statistical methods Biological Availability Drugs Therapeutic equivalency Research Statistical methods Statistics as Topic methods Therapeutic Equivalency Statistik (DE-588)4056995-0 gnd Bioverfügbarkeit (DE-588)4145660-9 gnd Bioäquivalenz (DE-588)4204145-4 gnd |
| topic_facet | Statistik Bioavailability Research Statistical methods Biological Availability Drugs Therapeutic equivalency Research Statistical methods Statistics as Topic methods Therapeutic Equivalency Bioverfügbarkeit Bioäquivalenz |
| url | http://bvbr.bib-bvb.de:8991/F?func=service&doc_library=BVB01&local_base=BVB01&doc_number=008924604&sequence=000002&line_number=0001&func_code=DB_RECORDS&service_type=MEDIA |
| volume_link | (DE-604)BV013101415 |
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