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But what are the key potential changes and how could they impact drugdevelopers and manufacturers? He noted that within the proposals, there is likely to be a differentiation in incentives for drugdevelopment in the orphan and unmet medical need areas. Key areas of potential legislative change. Future outlook.
As formulators, we are often able to directly impact the amount of drug absorbed through formulation optimization and improve exposure. However, the chances of improving the exposure profile of a drug that is highly cleared by formulation modification are limited. S54 – S61 (2001).
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