Objectives
Survey the publicly available scientific literature as it relates to your drug class.
Determine the availability of publications that describe PK and PD of one or more drugs from your group’s drug class.
Begin to distinguish published data as describing PK vs. PD properties, in vitro vs. in vivo studies, and preclinical vs. clinical studies.
Directions
First, you will need to find at least five articles that you believe present PK and PD data related to your chosen drug class and/or drug. Note that not all articles need to have both PK and PD, but among the 5 articles, both PK and PD must be represented.
For each of the 5 articles, write a few sentences, in your own words, that describe the main PK and/or PD finding(s).
As examples,
“Publication #1 was a study that included assessment of the PK of drugX in mice that received 10 mg/kg oral doses . The results indicated DrugX is extensively metabolized into active metaboliteX, which is primarily excreted in urine. The authors concluded that a majority of the activity of DrugX resides within active metaboliteX.”
“Publication #2 evaluated the clinical efficacy of DrugX in a randomized phase 3 clinical trial. A total of 430 patients were accrued to the study, in which patients received either drugX at a daily dose of 50 mg orally or the standard of care therapy, drugY, at a dose of 10 mg twice daily. The results indicated patients receiving drugX had a higher response rate (54%, 95% CI 40% – 68%) compared to those receiving drugY (37%, 95% CI 21% – 51%). This study enabled FDA approval of drugX in the disease population evaluated.”
Next, select one of the articles that includes PK data and one that includes PD data (or if one article includes both PK and PD, you may use a single article) .
For each, write one brief paragraph summarizing the PK and PD data in more detail.
For example, was the PK data from in vitro studies (i.e. in cell culture or cell-free systems), in animals or in humans? What PK parameters were reported? What pharmacodyanmic parameter was being studied? How did the investigators measure drug or metabolite concentrations (for PK) or the efficacy or toxicity endpoints (for PD)? Was the PD endpoint a molecular marker (e.g. gene or protein expression) or a clinical endpoint (heart rate, blood pressure, glucose levels, pain, fatigue, etc.)?
NOTES: You will use peer-reviewed, scientific journal articles as your primary source of information in this course (roughly 70 – 95%).
The remaining material (roughly 5 – 30%) will come from FDA reports or other, official scientific documents from companies or regulatory agencies. Realize that marketing websites do not represent official scientific documentation.
Also, since this assignment is early in the course, we do not expect you to fully understand all PK/PD parameters, how they are measured or what they may mean in the context of the studies. Most importantly, we want you to begin exploring these and begin to familiarize yourself with the various concepts, which by the end of the course, we expect you will have mastered.
What to Include
Submit your work as a single word document with the following:
5 brief summaries – one for each article – which are two to three sentences in length, for articles that relate to your chosen drug class.
Two paragraphs describing PK and PD data from the articles.
Each article properly cited in a “References” or “Bibliography” page. Please note that we will not be critical of the reference style you use.
To make it easy for now, simply adopt one of the styles within the References section of one of the published scientific articles that you review.
Ultimately, your group project report should include a References section with citations that are consistent throughout the report document.
As long as the reference style used is consistent with one or more peer reviewed scientific journals and includes all appropriate details (author names, article title, journal name, volume/issue, and publication date), it will be fine.
Resources
RESOURCE: PubMed Search Tips
RESOURCE: FDA Search Tips
RESOURCE: Scientific Communication and Writing
