Design and Analysis of Bioavailability and Bioequivalence
Seiten
1992
Marcel Dekker Inc (Verlag)
978-0-8247-8682-3 (ISBN)
Marcel Dekker Inc (Verlag)
978-0-8247-8682-3 (ISBN)
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This reference/text, written at a basic mathematical and statisical level, presents important statistical concepts for assessing bioequivalence through "real" examples and provides a thorough, unified discussion of the design and analysis of bioavailability and bioequivalance studies.
This practical reference/text, written at a basic mathematical and statistical level, presents important statistical concepts for assessing bioequivalence through "real" examples and provides a thorough, unified discussion of the design and analysis of bioavailability and bioequivalence studies. Furnishing a comprehensive overview of the field and comparing average bioavailability methods, "Design and Analysis of Bioavailability and Bioequivalence Studies": supplies a simple formula for sample size determination; explains techniques for checking model assumptions and detecting outlying data; compares the additive model and the multiplicative model; demonstrates statistical methods of assessing more than two formulations; and delineates bioequivalence assessment with negligible plasma levels. As a fundamental text in the classroom or for self-education, "Design and Analysis of Bioavailability and Bioequivalence Studies": contains various study designs based on different needs and objectives; offers over 400 display equations but requires no mathematics beyond simple algebra; and incorporates time-saving SAS programmes and an appendix of statistical tables.
"Design and Analysis of Bioavailability and Bioequivalence Studies" is intended for biostatisticians; applied statisticians; biometricians; pharmacologists; clinical, industrial and research pharmacists; and drug regulatory personnel; as well as an for all upper-level undergraduate and graduate courses in bioavailability and bioequivalence, pharmacokinetics, pharmaceutics and biostatistics.
This practical reference/text, written at a basic mathematical and statistical level, presents important statistical concepts for assessing bioequivalence through "real" examples and provides a thorough, unified discussion of the design and analysis of bioavailability and bioequivalence studies. Furnishing a comprehensive overview of the field and comparing average bioavailability methods, "Design and Analysis of Bioavailability and Bioequivalence Studies": supplies a simple formula for sample size determination; explains techniques for checking model assumptions and detecting outlying data; compares the additive model and the multiplicative model; demonstrates statistical methods of assessing more than two formulations; and delineates bioequivalence assessment with negligible plasma levels. As a fundamental text in the classroom or for self-education, "Design and Analysis of Bioavailability and Bioequivalence Studies": contains various study designs based on different needs and objectives; offers over 400 display equations but requires no mathematics beyond simple algebra; and incorporates time-saving SAS programmes and an appendix of statistical tables.
"Design and Analysis of Bioavailability and Bioequivalence Studies" is intended for biostatisticians; applied statisticians; biometricians; pharmacologists; clinical, industrial and research pharmacists; and drug regulatory personnel; as well as an for all upper-level undergraduate and graduate courses in bioavailability and bioequivalence, pharmacokinetics, pharmaceutics and biostatistics.
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 intra-subject 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; references; appendix a - statistical tables; appendix b - SAS programmes.
| Reihe/Serie | Statistics: Textbooks & Monographs ; v. 133 |
|---|---|
| Zusatzinfo | Illustrations |
| Verlagsort | New York |
| Sprache | englisch |
| Maße | 165 x 241 mm |
| Gewicht | 771 g |
| Themenwelt | Mathematik / Informatik ► Mathematik |
| ISBN-10 | 0-8247-8682-3 / 0824786823 |
| ISBN-13 | 978-0-8247-8682-3 / 9780824786823 |
| Zustand | Neuware |
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