๐”– Bobbio Scriptorium
โœฆ   LIBER   โœฆ

An Alternative Approach for the Assessment of Bioequivalence Between Two Formulations of a Drug

โœ Scribed by Dr. Shein-Chung Chow; Dr. Jun Shao

Publisher
John Wiley and Sons
Year
2007
Tongue
English
Weight
332 KB
Volume
32
Category
Article
ISSN
0323-3847

No coin nor oath required. For personal study only.

โœฆ Synopsis

Swut rmzry

The problem of the assessment of biocquivalencc bet\sreii Q test forniiilation (T) and a reference formnlation (R) of n drug using a two-way crossover experiment is considered. To claim bioequivalence between two formulations, i t is required by the United States Food and Drug -4dministration (FDA) to dcnionstrate that the true ratio of means p ~/ p ~ of pharinarokinetic parameters of concern falls within some reasonable limits (cs., (80 0/0, 120 %)) with certain assurance. -4 rommonly used approach is to construct a n approximate 90 0,; confidence interval for p ~/ p ~ and, compare it with (80 O,b, 120 0 ; ) . I n this paper, an exact approach according to the FD-I's criteria, is proposed. The proposed procedure is derived by constriirting an exact confidence region (an clli)se) for ( p ~, p ~) and coniparing i t vith t h e region bouiidcd by / 1 ~= 0 . 8 p ~ and /iT=i.2/IR. Iheqitivalence is ronclrided if the ellipse IS within t lie critical region.

๐Ÿ“œ SIMILAR VOLUMES

A practical approach for the assessment
A practical approach for the assessment of bioequivalence under selected higher-order cross-over designs
โœ Jouni Vuorinen ๐Ÿ“‚ Article ๐Ÿ“… 1997 ๐Ÿ› John Wiley and Sons ๐ŸŒ English โš– 129 KB ๐Ÿ‘ 2 views

The two-period cross-over design with two sequences of drug administration is a standard experimental design when bioequivalence of one test formulation is to be assessed in comparison with a reference formulation. Previously, an approach based on Fieller's confidence interval has been presented for

The third-dimensional structure of the c
The third-dimensional structure of the complex between an Fv antibody fragment and an analogue of the main immunogenic region of the acetylcholine receptor: A combined two-dimensional NMR, homology, and molecular modeling approach
โœ Jens Kleinjung; Marie-Christine Petit; Piotr Orlewski; Avgi Mamalaki; Socrates J ๐Ÿ“‚ Article ๐Ÿ“… 2000 ๐Ÿ› Wiley (John Wiley & Sons) ๐ŸŒ English โš– 351 KB ๐Ÿ‘ 1 views

## Binding of autoantibodies to the acetylcholine receptor (AChR) plays a major role in the autoimmune disease Myasthenia gravis (MG). In this paper, we propose a structure model of a putative immunocomplex that gives rise to the reduction of functional AChR molecules during the course of MG. The mo