With the data that is being generated, you’re expected to make informed decisions as quickly as possible. 2011. The GastroPlus PBBM / PBPK modeling and simulation package – supporting internal research through regulatory filings…Īs a researcher in the life sciences space, you can’t measure everything as a project winds its way through the R&D process. Recombinant factor IX-Fc fusion protein (rFIXFc) demonstrates safety and prolonged activity in a phase 1/2a study in hemophilia B patients. Shapiro AD, Ragni MV, Valentino LA, Key NS, Josephson NC, Powell JS, et al. Safety and prolonged activity of recombinant factor VIII Fc fusion protein in hemophilia A patients.
Powell JS, Josephson NC, Quon D, Ragni MV, Cheng G, Li E, Jiang H, Li L, Dumont JA, Goyal J, Zhang X, Sommer J, McCue J, Barbetti M, Luk A, Pierce GF. In vitro dissolution profile comparison-statistics and analysis of the similarity factor, F2. B-domain deleted recombinant factor VIII preparations are bioequivalent to a monoclonal antibody purified plasma-derived factor VIII concentrate: a randomized, three-way crossover study.
Kessler CM, Gill JC, White GC, Shapiro A, Arkin S, Roth DA, et al.
In case 3, DTAARRAY variables were used to perform a looping operation to calculate the difference factor ( F1) and the similarity factor ( F2) in support of in vitro bioequivalence evaluations. In case 2 (pre-processing data), a baseline correction decision tree was programmed into the PK model to account for both the endogenous baseline level as well as the presence of residual drug. In case 1 (post-processing data), DTA variables were used to calculate three user-defined parameters in the primary PK model. We demonstrated the application of this strategy through three case study examples. We propose a method of leveraging DTA and DTAARRAY variables plus simple programming techniques in an ASCII model to automate these user-defined calculations in WinNonlin and eliminate the need for manual handling of data outside of the primary analysis. Such analysis approaches increase the risk of generating data defects and can employ software that is not fully compliant. Conventionally, these calculations are often executed outside of the primary PK analysis by pre- or post-processing data from multiple sources, manually entering formulas and multiple additional set-ups. In pharmacokinetic (PK) analysis, there are many occasions where user-defined calculations need to be performed before or after the primary PK modeling/analysis.
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