Guidelines for the performance and analysis of bioequivalence studies are not very specific. The advantages and disadvantages of the following methods and tests are discussed: analysis of variance by summation or by use of general linear models, nonparametric procedures, aposteriori probabilities an
Rationale and conditions for the requirement of chiral bioanalytical methods in bioequivalence studies
✍ Scribed by Juan José Torrado; María Blanco; Magí Farré; Pere Roset; Alfredo García-Arieta
- Publisher
- Springer
- Year
- 2010
- Tongue
- English
- Weight
- 153 KB
- Volume
- 66
- Category
- Article
- ISSN
- 0031-6970
No coin nor oath required. For personal study only.
📜 SIMILAR VOLUMES
## Abstract A novel High Performance Liquid Chromatography — electrospray mass spectrometric method has been developed for the estimation of Ursodiol (Ursodeoxycholic acid)‐a bile acid, in human plasma using Ornidazole as internal standard. The methodology involved solid phase extraction of the ana
Characteristics of the variance component for the subject-by-formulation interaction ( 2 D ), estimated in simulated studies of individual bioequivalence and in three-and four-period cross-over trials reported by the FDA, were compared. 2 D was estimated by (i) restricted maximum likelihood (REML) a