Pharmaceutical Consulting and Project Management: Preclinical - CMC - Regulatory

image description

PDI Blog

What is Oral Bioavailability?

Saturday, November 05, 2011
The term oral bioavailability is frequently misused. It is the percentage of the total dose that reaches the bloodstream, but it does not all reach the bloodstream at once, and so one cannot simply take a blood sample, find out how much drug is in it and divide that amount by the dose. It is quite strictly defined when used correctly. There a level of ambiguity in the scientific literature that has led some people to confuse oral absorption with oral bioavailability. The best way to understand how to use this information in developing oral formulations is to understand the barriers a drug molecule must cross to get from the dosage form in the gut to the bloodstream. We have several tools including PK modeling and GastroPlus that can help us visualize and design oral formulations that can optimize bioavailability and improve potential outcomes. Take at look at the article “What is Oral Bioavailability?” in our Resource Center for a more in-depth discussion. In some special cases we may want to prevent it. A White Paper “What if you don’t want bioavailability” that explores this topic is also available in our Resource Center.  We’re interested in hearing some opinions or comments from our readers. More...

What is biopharmaceutics really useful for?

Saturday, October 22, 2011

Biopharmaceutics is defined as the study of the physical and chemical properties of drugs and their proper dosage as related to the onset, duration and intensity of drug action. The science of biopharmaceutics is essentially comparing the dissolution of a drug to its in-vivo performance and its effectiveness. Passing this evaluation based on specific criteria has been one of the keys to getting approval from the US Food and Drug Administration.  But, there is much more value to this science then initially meets the eye.  Read the rest at our Resource Center White Papers.
 More...