Bioequivalence and Bioavailability Forum

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❝ how should the healthy subjects be dosed in a BE study? should they be dosed by taking into account their body weight […] or regardless of their body weight take the 1000 mg tab?

When you talk about healthy subjects I guess you are referring to bioequivalence? See EMA’s definition:

Two medicinal products containing the same active substance are considered bioequivalent if they are pharmaceutically equivalent or pharmaceutical alternatives and their bioavailabilities (rate and extent) after administration in the same molar dose lie within acceptable predefined limits.

(my emphasis)

EMA wants BE to be demonstrated for the highest strength (under certain conditions BE-studies of lower strengths can be waived).

• In a cross-over study the concentration influenced by bodyweight is irrelevant (the comparison is done within subjects).
  
• In a parallel design you should try to keep the average bodyweights of groups as close as possible.