Feb22 Preclinical QSP Modeling in the Pharmaceutical Industry
The cost of developing drugs is rising rapidly, and the number of new drug approvals per dollar spent showed a decline over the last decades. Approximately 90% of investigational drugs fail before being approved for use in patients, mostly attributed to either lack of efficacy or to drug-induced sa... Read More..
Jan26 The Proof Is in the Pee: Crowdsourcing for Hands-on Teaching of Clinical Pharmacology
Does your pee stink after eating asparagus? In many people, eating asparagus is associated with the production of malodorous urine. A team convened at the American Society for Clinical Pharmacology and Therapeutics (ASCPT) to use this observation to better understand urinary odor kinetics after co... Read More..
Dec27 PSP Launches Neuroscience Virtual Issue
In the early 1950's, Alan Hodgkin and Andrew Huxley published a series of papers on the fundamental mechanism by which membrane currents are generated and travel in neurons. Their mathematical model describing these events quantitatively became universally known as the Hodgkin & Huxley model, w... Read More..
Dec15 Physiologically Based Pharmacokinetics in FDA Drug-Drug Interactions Guidances
The use of physiologically based pharmacokinetic (PBPK) modeling in
evaluating drug-drug interaction (DDI) potentials is reinforced in the
US FDA’s new draft guidance for industry documents. Published on October 25, 2017, “ Clinical Drug Interaction Studies — Study Design, Data Analysis, and Cl... Read More..
Nov28 Memories of ACoP8
A few weeks ago we enjoyed another fantastic American Conference of Pharmacometrics (ACoP) meeting. The energy (and vitamin D) supply has kept me efficient throughout November in Sweden – very well done by the organizers! Read More..
Oct25 New Metric in Scholarly Publishing
CiteScore TM is a metric developed by Elsevier from the Scopus ® database of over 22,000 peer-reviewed journals, book series, conference proceedings, and trade publications, across 330 disciplines. CPT: Pharmacometrics & Systems Pharmacology 's 2016 CiteScore , released in June this y... Read More..
Sep28 NIH Workshop Examines Role of Quantitative Systems Pharmacology Approach to CNS Drug Discovery
An NIH workshop entitled, “Quantitative Systems Pharmacology and Drug Discovery: Filling the Gaps in Current Models of the R&D Process for Neurotherapeutics” was held in Bethesda, MD on July 26-27, 2017.
The workshop was a collaborative effort between NINDS, NIA, NIMH, NIDA and NCATS. Read More..
Aug25 PSP Publishes the First Modeling and Simulation Report from Japan's PMDA
The perspective " Quantitative Modeling and Simulation in PMDA: A Japanese Regulatory Perspective " by Sato and colleagues is the first report on the current state of modeling and simulations (M&S) in Japan's Pharmaceutical and Medical Device Agency (PMDA) in a peer-reviewed journal. It is also the... Read More..
Jul27 EMA Publishes a Commentary on the MID3 White Paper
The value of integrated modeling and simulation (M&S) as a decision-making tool is well established across a range of industries and disciplines, such as engineering, finance, aerospace, and weather forecasting.
Arguably, the pharmaceutical industry has been a relatively late adopter, but in the... Read More..
Jun21 PSP Publishes New Databases for Pharmacometrics & Systems Pharmacology
Most people probably associate the disciplines of Pharmacometrics and Systems Pharmacology in the first instance mainly with modeling and simulation. However, decades ago computer scientists had already pointed out the “garbage-in-garbage-out” (GIGO) principle, emphasizing the reliance of modelers... Read More..