Design and analysis of bioavailability and bioequivalence studies
著者
書誌事項
Design and analysis of bioavailability and bioequivalence studies
(Biostatistics, 3)
M. Dekker, c2000
2nd ed, revised and expanded
大学図書館所蔵 件 / 全5件
-
該当する所蔵館はありません
- すべての絞り込み条件を解除する
注記
Includes bibliographical references and index
内容説明・目次
内容説明
"Provides a comprehensive summary of the continuously growing literature and research activities on the regulatory requirements, scientific and practical issues, and statistical methodology of the design and analysis of bioavailability and bioequivalence studies. Includes several new chapters."
目次
- Designs of bioavailability studies
- statistical inferences for effects from a standard 2x2 crossover design
- statistical methods for average bioavailability
- power and sample size determination
- transformation and analysis of individual subject ratios
- the assessment of inter- and intrasubject variabilities
- assumptions and outliers detection
- optimal crossover designs for two formulations
- assessment of bioequivalence for more than two formulations
- assessment of bioequivalence for drugs with negligible plasma levels
- some related problems in bioavailability studies
- metanalysis for bioequivalence - review
- population and individual bioequivalence
- review of FDA guidances. Appendices: statistical tables
- SAS programs.
「Nielsen BookData」 より