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- W2402160189 abstract "For a new formulation of an existing drug, as well as for generics, one has only to demonstrate pharmacokinetic (PK) bioequivalence with the original formulation to obtain registration. This PK tests are performed in healthy young volunteers, taking for granted that PK follows pharmacodynamics (PD). However, this methodology hardly takes in account potential gender, size, age, maturation specific differences in bioequivalence. FDA and EMA-regulation on pediatric drug research have tried to find a compromise between minimal exposure of children to a pediatric research program, and acquiring minimal PK/PD and safety-data in children to reassure safe Introduction" @default.
- W2402160189 created "2016-06-24" @default.
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- W2402160189 date "2016-01-01" @default.
- W2402160189 modified "2023-09-27" @default.
- W2402160189 title "Bioequivalence in adults does not mean bioequivalence in children" @default.
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- W2402160189 hasPublicationYear "2016" @default.
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