Modeling, Simulation, and the Critical Path

The benefits of modeling and simulation fall into two categories: Increased certainty in trial designs and faster decisions to kill or advance compounds. The first, more tactical benefit means trials are less likely to fail because they are properly powered and optimally designed to address the hypotheses of interest. The second, more strategic benefit of […]

Read More
Topics:

The Future of the Pharmaceutical Sciences and Graduate Education: Recommendations from the AACP Graduate Education Special Interest Group

Despite pharma’s recent sea change in approach to drug discovery and development, U.S. pharmaceutical sciences graduate programs are currently maintaining traditional methods for master’s and doctoral student education. The literature on graduate education in the biomedical sciences has long been advocating educating students to hone soft skills like communication and teamwork, in addition to maintaining […]

Read More
Topics:

Do You Compute?

Candidate drugs emerging from discovery await in vivo PK evaluation prior to moving to late-stage development. Facing ever-increasing clinical development costs, drug companies are performing elaborate and intensive evaluations of PK/PD at earlier stages. The US Food and Drug Administration (FDA) Critical Path Initiative is calling for more use of PK/PD modeling.

Read More
Topics:

How PBPK modeling will make drugs safer, cheaper, and more effective

Daniel Weiner

Historically, drugs have been selected using various methods (e.g., biological and chemical screens). Candidate drugs were often pushed into the clinic with only a rudimentary understanding of the link between drug exposure and resultant effect(s). As a consequence, drug development has been inefficient by relying on trial and error at the clinical stage, not to […]

Read More
Topics: Model-based Drug Development, PBPK Modeling and Simulation
Learn More
LinkedIn