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RegisterLatest FDA product-specific guidelines – Some questions… [Regulatives / Guidelines]
❝ Is CYP2D6 substrate, poor/ultrarapid metabolizers might be the reason for high variability? Why not pheno/genotype the volunteers for BE-trial, to minimize variability?
Pheno/Genotype subjects for BE studies? Isn't that not advisable?
John
Complete thread:
- Latest FDA product-specific guidelines – Some questions… nobody 2017-07-19 10:56
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- Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-25 18:21
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- Latest FDA product-specific guidelines – Some questions… Achievwin 2017-07-25 17:33
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Ing. Helmut Schütz