May31 The Increasing Role of Systems Pharmacology, Biomarkers and Disease Progression Models in Developing Drugs for the Treatment of Rare Diseases
Rare diseases collectively represent a large medical challenge. With approximately 7,000 r are diseases, which include rare cancers to inherited metabolic disease and many exclusively in children, they present a significant unmet medical need. It is estimated that 350 million people worldwide su... Read More..
Apr19 MiDD Pilot Program: An Opportunity to Expedite Pediatric Drug Development
On April 17, 2018, the US FDA announced the Model-Informed Drug Development Pilot Program . The program fulfills one of the agency’s performance goals under its 6 th iteration of the Prescription Drug User Fee Act (DUFA VI, 2018-2022), which recognizes the importance of model-informed d... Read More..
Apr18 Revisiting PBPK Predictability Following FDA's Introduction of M&S in Its Pediatric Guidance
On April 11, 2018 the US FDA published a new Guidance for Industry “ ICH E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population ,” introducing the role of modeling and simulations (M&S) in pediatric drug development. The addendum appears to expect that s... Read More..
Mar30 Lung Themed Virtual Issue
The lung is an unusual organ from the perspective of drug delivery, since it is amenable to local administration. This concept has been successfully translated to clinical practice in pulmonary disease areas like asthma and chronic obstructive pulmonary disease (COPD). Physiologically-based pharma... Read More..
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 C... 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..