Design and analysis of bioavailability and bioequivalence studies [Elektronisk resurs] / authors, 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.

Ämnesord

Farmakologi  (sao)

Statistisk metod  (sao)

Bioavailability  -- Research -- Statistical methods. (LCSH)

Drugs  -- Therapeutic equivalency -- Research -- Statistical methods. (LCSH)

Biological Availability.  (MeSH)

Therapeutic Equivalency.  (MeSH)

Statistics as Topic  -- methods. (MeSH)

Pharmacology  (LCSH)

Statistics  (LCSH)

Indexterm och SAB-rubrik

Vd Farmakologi

Thi Matematisk statistik

Vd Farmakologi

Thi Matematisk statistik

Klassifikation

RM301.6 (LCC)

QV 38 (NLM)

615/.7 (DDC)

Vd:t/DR (kssb/8)

Thi/DR (kssb/8)

Vd:t (kssb/8)

Thi (kssb/8)