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Detail
BukuHow to Make Stability Studies More Efficient
Bibliografi
Author: Turvall, Elliot
Topik: Drug; Pharmaceutical; Fractional Designs
Bahasa: (EN )    
Penerbit: Master’s Thesis in Mathematical Statistics and Bioinformatics at Chalmers University of Technology and Göteborg University     Tempat Terbit: Göteborg    Tahun Terbit: 2004    
Jenis: Theses - Master Thesis
Fulltext: 7_How to Make Stability Studies More Efficient.pdf (302.03KB; 1 download)
Abstract
In pharmaceutical research, several tests are performed on a new drug product. One of these tests is a stability study that estimates the shelf life of the drug product, i.e. the amount of time it keeps stable. Normally, stability studies are conducted with a complete factorial design, where the design factors are batch, strength and package type. However, it is also possible to do this with a fractional factorial design, which will save lots of time and money. It is very important, though, to make sure not to lose too much precision in the estimates of interest. In this thesis, several different fractional factorial designs are compared to the complete factorial design in theoretical investigations as well as a case study. These analyses show that some fractional designs can be recommended, whereas others should not be used.
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