Design and analysis of bioavailability and bioequivalence studies. (©2009)

• Record Type: Book
• Further Information: Note: Shein-Chung Chow, Jen-pei Liu.
• Other Names: Chow, Shein-Chung, 1955-; Liu, Jen-pei, 1952-
• Contents: Design of bioavailability studies -- Statistical inferences for effects from a standard 2x2 crossover design -- Statistical methods for average bioequivalence -- Power and sample size determination -- Transformation and analysis of individual subject ratios -- Assessment of inter- and intra-subject 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.
• Edition: 3rd ed
• Publisher Details: Boca Raton : CRC Press
• Publication Date: 2009
• Copyright Date: 2009
• Extent: 1 online resource (xxii, 733 pages), illustrations
• Subjects: 615/.7; Bioavailability -- Research -- Statistical methods; Drugs -- Therapeutic equivalency -- Research -- Statistical methods; Biological Availability; Statistics as Topic -- methods; Therapeutic Equivalency; Médicaments -- Équivalence thérapeutique -- Méthodes statistiques; Épidémiologie -- Méthodes statistiques; Médicaments -- Biodisponibilité -- Méthodes statistiques; MEDICAL -- Pharmacology; Electronic books
• Languages: English
• ISBNs: 9781420011678; 1420011677
• Related ISBNs: 9781584886686; 1584886684
• Notes: Note: Includes bibliographical references (pages 647-667) and index.; Note: Print version record.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.