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The following message was posted to: PharmPK
Dear all,
If I want to authorize a water soluble powder, which contains an
antimicrobial compound as active substance and lactose as excipient,
how could I know that the lactose does not affect the absorption of
the active substance without conduction of a bioequivalence studies ?
Thank you,
Elsa Costa, MSc
Pharmacokinetic Assessor
INFARMED- Pharmaceutical Department
Av. do Brasil 53, Edificio Tome Pires 1749-004 Lisboa (Portugal)
Tel: +351 21 798 7271 Fax: +351 21 798 7248
elsa.costa.-a-.infarmed.pt
[Does the antimicrobial compound exhibit bioavailability problems,
low permeability, solubility? You could look at dissolution as an in
vitro test - db]
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