Recent Advisory Committee Meetings

The proceedings of two recent advisory committee meetings, one for the antiviral (AV) drug products and the other for the cardio-renal (CR) drug products, are noteworthy. Both these meetings devoted 50% of the total time to discuss the role of PK/PD in the AV and CR drug development. The AV advisory committee discussed the role of modeling and simulation in exploring various dosing regimens to appreciate resistance to the effects of protease inhibitors over cumulative exposure and the importance of compliance. The AV committee recommended that FDA should develop guidance to the industry on the role of PK/PD in developing AV drug products. The CR advisory meeting encompassed discussions on the need to determine the exposure-response relationship. The FDA presented retrospective dose-effect analyses of more than 10 antihypertensive agents previously approved over several years by the FDA [11]. The point that the dose-response range of most of the drugs did not allow adequate identification of the "optimum" dose was made. This affects several regulatory decisions such as approval of combination drug products and superiority claims. The outcomes of the meeting included: (1) use of modeldependent analysis to learn about the shape of the exposure-response curve and (2) need for more innovative designs that could potentially allow frequentist and Bayesian types of data analysis.

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Blood Pressure Health

Blood Pressure Health

Your heart pumps blood throughout your body using a network of tubing called arteries and capillaries which return the blood back to your heart via your veins. Blood pressure is the force of the blood pushing against the walls of your arteries as your heart beats.Learn more...

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