This article answers some of the questions about what multidrug (especially of unapproved drugs) faae i get tested as combinations. This is just a brief statement from the article.
http://the-scientist.com/2011/05/27/take-two-of-these/
This article answers some of the questions about what multidrug (especially of unapproved drugs) faae i get tested as combinations. This is just a brief statement from the article.
http://the-scientist.com/2011/05/27/take-two-of-these/
Though increasingly sophisticated research is making the selection and targeting of the right steps in a disease pathway more likely, how best to conduct clinical efficacy trials of combination therapies remains somewhat unsettled, Friedman adds. “The biggest worry is how to prove that the single agents are not providing sufficient benefit,” she says. While preclinical work may suggest that a combo therapy is the best way to go, testing the drugs in tandem makes it difficult to parse the effectiveness of each compound individually. And because demonstrating that the combo is better than either component on its own is one of the FDA guidelines, Friedman continues, Phase II studies may require multiple arms that test each agent in isolation as well as in combination.
Furthermore, the FDA guidelines are just that. The agency currently has no established approval protocol for novel combination therapies, making the undertaking risky and potentially expensive. That, according to Troy Wilson, president and CEO of the California–based biotech Intellikine, is why Big Pharma is first to launch into the novel-combination-therapy arena. Larger pharmaceutical companies are better positioned to take on the initial risk because they can spread costs across their large portfolios, he says. However, thanks to biotechs’ ability to efficiently pull together specialized research teams, there could also be opportunities for such firms to conduct smaller-scale preclinical and early-phase studies, Wilson adds.
