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According to F.D.A. rules, the new generic version must "have the same active ingredient, strength and dosage form" as the brand name or reference product.
The generic manufacturers say that if a biosimilar has a different name from the reference product, substitution by a pharmacist would not be allowed.
Therefore, results were reported in relation to the reference product milk powder.
The fenofibrate-loaded mesoporous silica formulation was compared directly to a commercial reference product, Lipantil Supra®.
However, TDCs usually are lack of reference product classes, market data, and other necessary inputs data.
Sample size estimation is a vital step for bioequivalence studies comparing a reference product with a new/generic (test) product.
Pharmacokinetic parameters of Cmax, AUC0 t and AUC0 ∞ were calculated to compare a test product with CADUET® reference product.
In a typical bioequivalence study, two products, T (test product) and R (reference product), are each administered.
Given its volumetric qualities and its action on cutaneous trophicity, adipose tissue can be considered the reference product for filling.
As reference product Nutramigen® (NUT) was used.
R and R′ denote two administrations of the reference product.
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