Development of an analytical methodology from toxicokinetic to clinical studies for the anti-migraine drug frovatriptan
2000
Laugher, L. | Briggs, R. | Doughty, J. | Noctor, T. A. G.
To support the development programme of the anti-migraine drug, frovatriptan, an analytical method using HLPC-UV was validated in rat blood and subsequently cross-validated in dog and mouse blood to analyse samples generated from pre-clinical studies. The method was also evaluated in rabbit blood, however the method proved insufficiently selective/specific for this particular matrix. A need for a more sensitive method suitable for the analysis of a large number of samples to support clinical studies was identified. Advances in analytical technology over this period of development led to the development of LC-MS-MS analytical methods for human and rabbit whole blood that were appropriate, for the changing requirements of each study. A summary of the respective validation data, together with a discussion on the validation procedures employed, has been presented.
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