Resolution to Dissolution: Making Better Drugs


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By Dave A. Miller

There is a widening gap between the discovery of potential new drugs and their successful product development. Drugs are increasingly complex and diverge from Lipinski’s rule of 5, the industry standard for predicting a drug’s bioavailability and solubility. Contemporary literature reports that greater than 70% of new chemical entities (NCEs) currently in development are not easily dissolved in water and thus not practical for oral absorption. Most of these compounds require formulation intervention to enable sufficient bioavailability and achieve therapeutic efficacy. Amorphous solid dispersions (ASDs) are becoming invaluable in literally “solving” this drug solubility problem (see Figure). Continue reading

First-in-Class Gene-Cell Biological Product Set for Approval


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By Vien Lai

For many reasons, no gene-cell therapies have been approved by the Food and Drug Administration (FDA). However, one recent modified-cell biological product is changing that status. This product potentially cures a rare and difficult to treat relapsed/refractory B-cell acute lymphoblastic leukemia (acute lymphocytic leukemia [ALL]). As with many complicated drug products, FDA asked the Oncologic Drugs Advisory Committee (ODAC) for advice with evaluation and approval. Continue reading

How Can Reviewing Science Help Your Career?


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By Vivek Agrahari

Vivek AgrahariPeer review is an integral part of the scientific process and ensures the validity of scientific publications. Constructive feedback from peer reviewers greatly improves a manuscript. It is our professional responsibility to be part of the scientific process as a reviewer and/or author. Interest in becoming a reviewer is stimulated by keenness to become more visible in your field, advancing the science, and the need for improvement in knowledge, competence, and effectiveness. Continue reading