Our Mission
Our mission is to support the best practices and quantitative approaches for drug research & development at various stages. We strive to provide consultation and analysis for your related needs using mathematical models and statistical science by integrating knowledge across studies and/or programs.
What We Do
Our consulting services include population PK modeling, exposure response (PK/PD) analyses, model-based clinical trial simulations (CTS), or model based meta-analysis (MBMA) to help understand the characteristics of the drug, and to support dose selection and/or optimal sampling. We also provide high quality report writing services, resulting in an industry standard technical document/ready for regulatory submission. We are sub-contracted with Projections Research Inc.
An Emerging Science
How Regulatory Agencies Utilize Pharmacometrics
"FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development."
An Emerging Science
How Regulatory Agencies Utilize Pharmacometrics
"A variety of drug development, regulatory, and therapeutic questions are addressed by CDER through modeling and simulation strategies. CDER’s Office of Translational Sciences (OTS) uses these same strategies in the review of Investigational New Drugs Applications (INDs) and New Drug Applications (NDAs)... [M]odeling and simulation that incorporates aspects of individual physiology and genetics in drug metabolizing enzymes is being used to identify patient subgroups that need dose adjustments."
An Emerging Science
How Regulatory Agencies Utilize Pharmacometrics
"Another example is the use of modeling and simulation to assist in the creation of natural history databases to support model-based drug development. This could make clinical trials more efficient—for example, by enabling FDA to model some aspects of the behavior of the placebo arm in clinical trials. Right now, FDA is collaborating with scientists to develop such natural history models in Parkinson’s disease, Huntington’s disease, Alzheimer’s disease, and muscular dystrophy."
Collaborations
-Coming Soon-
Education/Training
An adjunct lecturer at the University of Tokyo, biostatistics programs funded by Japan Agency for Medical Research and Development (AMED), term 2019 to 2023
(link in Japanese only)
Experience
20+ years of experience in pharmacometrics/pharmaceutical industries. The area of expertise and list of publication is found in About Us page.
News
-Coming Soon-