Clinical pharmacology and therapeutics
Feb 11, 2020
When treating multiple complex diseases, such as cancer, polytherapy may demonstrate efficiency than monotherapy. However, due to the multiplicative relationship between the number of drugs and cell lines vs. the number of combinations, it is impract...
Clinical pharmacology and therapeutics
Jan 28, 2020
There is an unmet need for identifying innovative machine learning (ML) strategies to improve drug treatment regimens and therapeutic outcomes. We investigate Generalized Pharmacometric Modeling (GPM), a novel paradigm that integrates ML algorithms w...
Clinical pharmacology and therapeutics
Jan 26, 2020
Understanding all aspects of developmental biology, or pediatric ontogeny, that affect drug therapy from the fetus to the adolescent child is the holy grail of pediatric scientists and clinical pharmacologists. The scientific community is now close t...
Clinical pharmacology and therapeutics
Jan 22, 2020
Despite the application of advanced statistical and pharmacometric approaches to pediatric trial data, a large pediatric evidence gap still remains. Here, we discuss how to collect more data from children by using real-world data from electronic heal...
Clinical pharmacology and therapeutics
Dec 19, 2019
Lower clearance of immune checkpoint inhibitors is a predictor of improved overall survival (OS) in patients with advanced cancer. We investigated a novel approach using machine learning to identify a baseline composite cytokine signature via clearan...
Clinical pharmacology and therapeutics
Dec 9, 2019
The Pharmacogene Variation Consortium (PharmVar) provides nomenclature for the highly polymorphic human CYP2D6 gene locus. CYP2D6 genetic variation impacts the metabolism of numerous drugs and, thus, can impact drug efficacy and safety. This GeneFocu...
Clinical pharmacology and therapeutics
Nov 5, 2019
In 2009, the Clinical Pharmacogenetics Implementation Consortium (CPIC, www.cpicpgx.org), a shared project between Pharmacogenomics Knowledge Base (PharmGKB, http://www.pharmgkb.org) and the National Institutes of Health (NIH), was created to provide...
Clinical pharmacology and therapeutics
Jun 12, 2019
Generic drug products are approved by the US Food and Drug Administration (FDA) through Abbreviated New Drug Applications (ANDAs). The ANDA review and approval involves multiple offices across the FDA. Forecasting ANDA submissions can critically info...