Pharmacokinetics, or PK, is the monitoring of the concentration level over time of an analyte within a human (or animal) body. The analyte is typically an active ingredient of a drug, or an element such as sodium or potassium, or a chemical compound which occurs naturally in blood or other body fluids, such as creatinine or bilirubin. PK data collection for an active drug compound is performed routinely in all clinical trials since it is a critical part of measuring the safety and efficacy of an experimental treatment and in determining the treatment dose amount, frequency, and time-release profile.
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In Part 1, we will discuss a general overview of how Pharmacokinetics and Pharmacodynamics (PK/PD) plays a key role with 3 key stakeholders: Patients, Drug Companies, and the Federal Drug Administration.
Florence Nightingale began to record data on patients, most notably, credited as being one of the first to use picture graphs and statistical analysis reports (something DataCeutics knows a bit about!).
Our last dog, Baxter, was a rescue dog and we had fallen in love with him over six years ago. His death came as a shock. So after about a week of somber mourning, the kids and I decided that we might want to look for another rescue.
“I could hardly believe the generosity of these kids and their parents,” Dave Ferdock says. “It was overwhelming that such kindness by so many, was shown to people our students didn’t even know.” He continued, "Altogether, fifty backpacks were collected and filled with a myriad of school necessities."
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“For the past six years, I have been volunteering in Allentown, Pennsylvania in drug and alcohol abuse treatment facilities, says Matthew Ferdock, CEO of DataCeutics. “During the Holidays this past year, I reflected back on how many people feel the weight of loneliness and take to the bottle or reach for drugs to avoid their feelings. For them, living life is nearly impossible. Our goal as volunteers is to help them make it hour-to-hour,” he says.
Around the time CDISC was gaining momentum, my partner, and President of DataCeutics, Paul Gilbert established an internal group, the CDISC Center of Excellence (CoE) whose mission was to inform the rest of the company on new developments and challenges to implementing standards across the pharmaceutical/biotech research landscape.