After a much longer delay that I expected, I am back to blogging on a regular basis. Today I want to discuss a common topic among clinical pharmacologists. How do you properly design a drug-drug interaction study? Defining drug-drug interactions While these studies may appear complicated, they can be simplified very quickly to make the … Continued
I apologize to all my readers for such a long lapse between posts. After a very busy summer and fall, I am back to posting regularly to my blog about PK/PD topics. When analyzing PK/PD data, one of the most important plots used to visualize the data is to plot time-matched PK/PD data on a … Continued
In May 2011, T.J. Smith and B.E. Hillner published an opinion piece in the New England Journal of Medicine titled “Bending the Cost Curve in Cancer Care” (link). In this opinion piece, Smith and Hillner suggest that the rapidly increasing cost of treating cancer is not sustainable. “We must find ways to reduce the costs … Continued
The process of curve stripping is used in both compartmental and non-compartmental analysis. Each pharmacokinetic profile is made up of one or more exponential phases. The “curve stripping” process extracts each of these exponential phases from the pharmacokinetic profile in a manual fashion that does not require non-linear curve fitting. This method was originally used … Continued
In this third and final post about by review of the Phoenix WinNonlin software, I review the newest feature of the software and provide overall thoughts. You can read about the Phoenix platform in Part 1 of my review, and the non-compartmental and single subject analysis in Part 2 of my review. With the exception … Continued
Part 2 of the WinNonlin review will cover the non-compartmental and PK modeling functions of Phoenix WinNonlin. To many people, these two features have defined WinNonlin for many years. And the updated software does not disappoint with significant improvements to the functionality, ease of use, automated graphics, and other features. As I discussed in Part … Continued
WinNonlin by Certara has been a fixture in pharmacokinetic analysis software for over 20 years. While it has been known as a tool for non-compartmental analysis and model-based analysis of single subject data, the new Phoenix WinNonlin creates an entirely new platform for pharmacokinetic and pharmacodynamic analysis. Similar to my other reviews. I will be evaluating features … Continued
Elizabeth Weise, a USA Today journalist, posted a story titled “Journals: USA, others need to re-tool their science programs” on April 22, 2011 (link). The premise of the article is that the journal Nature is reporting that there are not enough academic positions available for the number of PhD graduates, and that non-academic industries are … Continued
One of the key things to do during the transition from preclinical development studies to clinical development studies is to set the target for your drug assay limit of quantification (LOQ). I will outline a few considerations on that topic. Here are my main assumptions: You are working with a drug that is intended for … Continued
BLQ values are like those pimples we used to get as teenagers. They often show up at the worst time and they always seem to be in the wrong place. (Is their really a “right” place for a pimple!?) Then what do you do with the pimple? Rub some alcohol on it, put other medication, … Continued
