Bioavailability Can Best Be Described as a Process When Drug

Although there was no correlation between in vitro dissolution and in vivo bioavailability the profiles shown in Figure 9 may still reflect the in vivo dissolution. Because coenzyme Q 10 is classified as a Class II drug according to the Biopharmaceutics Classification System 32 its absorption could be rate-limited by the dissolution process.

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3 5 6 Inhibitors include clarithromycin erythromycin ritonavir and verapamil.

. Inducers include rifampicin and St Johns wort. Peak time when maximum plasma drug concentration occurs is the most widely used general index of absorption rate. The slower the absorption the later the peak time.

The best that any project team can do is set clear GoNo-Go criteria and design a preclinical strategy focused on identification of key issues to weed out problematic drug candidates early in the process. Bioavailability determinations based on the peak plasma concentration can be misleading because drug elimination begins as soon as the drug enters the bloodstream. Successful drug delivery to the intended target sites of action is dependent on multiple factors including the individuals physiology and the drugs physicochemical properties solubility dissolution stability permeability and metabolism.

Preclinical drug development is often called the Valley of Death where good ideas often die through design flaws lack of specialized. And used in any of the bioequivalence or bioavailability studies described in 32038 or 32063 of. At specific times during the drug investigation process meetings between FDA and a sponsor can be especially helpful in minimizing wasteful expenditures of time and money and thus in speeding the drug development and evaluation process.

3 The pharmacokinetics of a drug may be altered when co-administered with compounds which inhibit or induce P-glycoprotein. P-glycoprotein is an important mediator of drug-drug interactions.

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