Parenteral Bioequivalence [Design Issues]
Hi Alhas,
sometimes the intestinal absorption (rate and/or extent) of an oral drug can be affected by food intake / food factors. When comparison between two formulations is done, one should accordingly make sure that the formulations are not too different in terms of the effect of food.
When you inject a solution/suspension you bypass gastrointestinal absorption. Therefore, I don't see a need to consider food effects.
I am not aware of any parenteral drug product with an SPC in which it is stated that food may affect its pharmacological properties. If one such exists it would be tremendously interesting to hear about it.
Darn, now I got really hungry.
Best regards
EM.
sometimes the intestinal absorption (rate and/or extent) of an oral drug can be affected by food intake / food factors. When comparison between two formulations is done, one should accordingly make sure that the formulations are not too different in terms of the effect of food.
When you inject a solution/suspension you bypass gastrointestinal absorption. Therefore, I don't see a need to consider food effects.
I am not aware of any parenteral drug product with an SPC in which it is stated that food may affect its pharmacological properties. If one such exists it would be tremendously interesting to hear about it.
Darn, now I got really hungry.
Best regards
EM.
Complete thread:
- Parenteral Bioequivalence BEAZ 2008-07-24 14:05
- Parenteral BioequivalenceElMaestro 2008-07-25 09:01
- Parenteral Bioequivalence BEAZ 2008-07-25 12:11
- Parenteral Bioequivalence H_Rotter 2008-07-25 12:35
- Parenteral Bioequivalence ElMaestro 2008-07-25 12:59
- Parenteral Bioequivalence Ohlbe 2008-07-25 17:25
- Parenteral Bioequivalence Helmut 2008-07-25 17:35
- Parenteral Bioequivalence BEAZ 2008-07-30 12:52
- Parenteral Bioequivalence BEAZ 2008-07-25 12:11
- Parenteral BioequivalenceElMaestro 2008-07-25 09:01
