In Vitro Bio-Availability Testing
Bioavailability is a measure of the effectiveness of the delivery of an active pharmaceutical compound to the place in the body where its presence is required. According to the FDA ‘Bioavailability means the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action (21 CFR 320.1(a)).’
It is a relevant measure to all routes of administration. In-vitro bio-availability assays can, in many cases, be used as an alternative clinical trial to demonstrate the delivery of a generic pharmaceutical. The FDA has published Guidance for its use with novel drugs.
MET’s analytical department can combine dissolution or other administration simulation methods with API concentration and stability studies. The process is applied to novel materials and RLD comparisons