What is PAGE?

1. The Community

PAGE is a group of individuals with a common interest in data analysis using the population approach. If you want to be a part of this community then please register by clicking on my profile on your left. If you have entered your personal information before at this web-site but no longer know your password, it can be mailed to you automatically using the my profile link. If you've both changed your e-mail address and do not know your password, please contact Rik Schoemaker (); do not create a new profile!

2. The Meeting

Each year a meeting is held in June at a different European location. The upcoming meeting will be two-and-a-half days and will be held in St. Petersburg, Russia, from Wednesday morning, June 24 to Friday noon, June 26 2009. Registration will not open until January 15, 2009, but if you sign up as a PAGE member, you will be kept notified.

3. The Online Journal

This web-site is also home of the official online journal PAGE. Abstracts of the Annual Meeting of the Population Approach Group in Europe. ISSN 1871-6032. All the abstracts for the past PAGE meetings can be accessed online through either the search function on the left or by going to the relevant PAGE meeting. Each abstract is formally and uniformly referenced as indicated when viewing the abstract.

Links to other Population Approach Resources

NONMEM®

NONMEM® software from GloboMax, LLC

• NONMEM Software and Support
• NONMEM Users Net Archive
• NONMEM ftp Repository at GloboMax
• NONMEM Project Group, UCSF

Pharsight

Pharsight develops and markets software and services that help pharmaceutical and biotechnology companies improve their decision-making in drug development and commercialization. By integrating scientific, clinical and business decision criteria into a dynamic, model-based methodology, Pharsight helps its customers optimize the value of their drug development programs and portfolios from discovery to post-launch marketing and any point in between.

Xpose 4

is a model building aid for population analysis using NONMEM®. Xpose produces various plots and analyses to facilitate data set checkout, goodness-of-fit analysis, model exploration and visualization, model diagnostics, candidate covariate identification and model comparison.  Xpose 4 is written in the programming language R and allows for integration into nearly any model building platform. New functionality in Xpose 4 allows the user to create simulation based reference diagnostics, compute the conditional weighted residuals and modify standard Xpose graphics to create publication quality figures.

Perl-speaks-NONMEM (PsN)

is a collection of Perl modules and programs aiding in the development of non-linear mixed effect models using NONMEM®. The functionality ranges from simpler tasks such as parameter estimate extraction from output files, data file sub setting and resampling, to advanced computer-intensive statistical methods. PsN includes both stand-alone tools as well as development libraries for method developers.

NMQual

by Metrum Research Group, LLC, manages NONMEM® installations by incorporating bug fixes, implementing user/site specific changes, and providing a complete, self-documenting record of a given NONMEM® installation for traceability and systems qualification purposes.

Wings for NONMEM

WFN is a set of DOS batch command files and awk scripts to help NONMEM® users be more productive. The first version of WFN (Wheels for NONMEM) was written in 1989 at UC San Francisco. The unix csh and awk scripts evolved and were eventually ported to DOS in order to support NONMEM as part of the RIDO (Right Dose First Time) project.

Census

is a comprehensive Windows-based analysis project manager for NONMEM, providing detailed summary, comparison and overview of the runs comprising a given project, including the display of output data, simple post-run processing, numerical output diagnostics, fast diagnostic plots (through tight integration with R and Xpose) and run output management, complementary to other available modeling aids.

BUGS

is a general-purpose program for Bayesian statistical analysis. BUGS version 0.6 can handle a wide range of models including linear mixed-effect models. The 1.4 version of WinBUGS is currently available and is capable of fitting non-linear mixed effect models; a specialist Windows interface for PK modelling (PKBUGS) is included.

MONOLIX 2.3

is a free MATLAB program that implements the SAEM algorithm for estimation in nonlinear mixed-effects models with several nice new features: library of usual PK and PD models, additional graphical output, enhanced interface, handling of measurements below limit of quantification etc. Also available as a stand-alone executable version that does not require MATLAB.

PFIM

is a collection of R functions for population designs evaluation and optimisation. It is based on the expression of the Fisher information matrix in nonlinear mixed effects models. The recent versions are PFIM Interface 2.1, for single response models which includes a graphical user interface, and PFIM 3.0 for multiple response models. Several new features are proposed. A library of usual PK models is available and other models can be written using an analytical form or using a differential equations system. Regarding optimisation, it can be performed using either the Simplex algorithm or the Fedorov-Wynn algorithm.

PopDesign

is an e-mail list server for questions and comments about the design of population PK and PKPD studies. The PopDesign mailing list would be an appropriate place to ask questions and post comments about the design of any study for which nonlinear mixed effects modelling is the proposed analysis tool. Members of the list includes those who have developed nonlinear mixed effects models design software: PFIM, PFIM_OPT, PkStamp, PopDes, PopED, POPT, WinPOPT.

EMEA

The European Agency for the Evaluation of Medicinal Products. The EMEA will be organising a workshop on paediatric modelling on April 14-15, 2008 (see this link).

GloboMax® Division of ICON plc - Europe and U.S. 

is a full service Product Development and Contract Research Organisation, serving the pharmaceutical, and biotechnology industries. Our presence in the U.K. represents our long-term commitment to provide European clients with the very best in product development, regulatory, pharmacokinetic, biostatistics, clinical and data management services. In addition to providing exclusive licensing and technical support for NONMEM®, GloboMax has introduced a NONMEM® shell called PDx-POP.

Exprimo NV

is a European consulting company with the emphasis of its activities focussed towards the application of quantitative, model based approaches at all stages of pharmaceutical development. Services offered include pharmacokinetic analysis and reporting, population PK/PD modelling as well as advanced drug-disease modelling and clinical trial simulations. All work is conducted to appropriate GCP or regulatory requirements.

Cognigen Corporation

is the industry leader in pharmacometric analysis. Close collaboration with our clients and a systematic approach to model-based drug development are the foundations of our success. Cognigen’s reputation for excellence stems from our highly experienced interdisciplinary teams, which combine reliability, integrity, and scientific acumen to deliver superior service.

EMF Consulting

is a group of pharmaceutical consultants who provide a wide range of drug development services. We offer consulting as members of a development team, we offer our expertise in the design, conduct, analysis and reporting of studies, we provide data sciences logistics, and write regulatory documents and PKPD modelling training.

LAP&P Consultants

provides interdisciplinary support on advanced pharmacokinetic and pharmacodynamic analyses to solve complex problems in preclinical and clinical drug development. LAP&P has a professional infrastructure for advanced PK/PD analyses and reporting for the pharmaceutical industry, based on the most recent developments in academic science. Services include Mixed Effect (population) analysis, Physiologically Based Pharmacokinetic (PB-PK) Modelling, disease progression analysis and clinical trial simulations.

Pharmacokinetic Resources

maintained by David Bourne, OUHSC College of Pharmacy. The purpose of this page is to provide links to information about the discipline of Pharmacokinetics.

RFPK

is the Resource Facility for Population Kinetics, a research resource sponsored by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) within the US National Institutes of Health. RFPK's mission is to continuously improve the quality of research in the biomedical community by widely distributing software and expertise related to population analysis. RFPK encourages collaboration at all levels of biomedical research. Areas of emphasis include intermediary metabolism, lipid metabolism and pharmacokinetics and pharmacodynamics, among others.

PKPD Software Server

at the Department of Anesthesia at Stanford. This server is maintained by Steven Shafer.

The Laboratory of Applied Pharmacokinetics, USC

directed by Roger W. Jelliffe.

Thermo Electron Corporation

Thermo is an ideal choice for companies seeking to standardize on LIMS, CDS and PK-PD solutions - supporting enterprise deployment and 21 CFR Part 11 compliance: Kinetica for population and standard PK/PD analysis; EP Series, an enterprise PK/PD data management solution, integrating with NONMEM, SAS, WinNonLin; SampleManager LIMS, an enterprise solution for multiple industries; Watson LIMS for pre-clinical & clinical bioanalysis; Galileo LIMS, for in vitro ADME studies; Nautilus LIMS, for discovery and R&D; Atlas CDS, for chromatographic instrument control, data acquisition and processing.

DruDevO

With 20+ years of experience in modeling and simulation we specialize in consultancy for DRUg DEVelopment Optimization using M&S methods. Based on the experience in this field we have also developed a time saving NONMEM interface which also links Windows to Linux/Mosix systems. We comply with GCP and 21 CRF 11 guidelines.

RDPP

Research and Development for Population Pharmacokinetics.

ASTER.CEPHAC

is a leading European contract research organization (CRO) providing clinical and bioanalytical services to pharmaceutical companies. With an average of more than 10 years experience and 3 full trained people dedicated to PK/PD, ASTER.CEPHAC provides the following services: PK and PK/PD analysis, population PK/PD modelling and simulation approaches, preparation of scientific publications and investigator's brochures.

Metrum Research Group LLC

is a for-profit research organization, focused on the investigation and application of innovative mathematical modeling and simulation methods in clinical pharmacology and related biomedical sciences. MetrumRG provides quality research and consulting services, emphasizing advanced population PK and PK-PD modeling and simulation, novel trial design and analysis, to the pharma/biotech industries and non-profit research centers. Other research initiatives include the implementation of open-source software and high-performance computing technologies to facilitate quantitative problem-solving.

Next Level Solutions

is a consulting company focusing on rapid turnaround population pk/pd analysis. We apply proprietary methods and high performance computing to standard population pk/pd software resulting in more robust solutions on a shorter timeline.

QuantPharm LLC

is a consulting company located in Maryland, US. It specializes in development and application of advanced mathematical modeling, simulation, and data mining methods to support pharmaceutical and biotechnology industries. QuantPharmTM offers fast, efficient and high quality population analysis of pharmacokinetic and pharmacodynamic data and model-based clinical trial simulations to support all stages of drug development, from pre-clinical to Phase IV.

Cellular Statistics, LLC

Tools and services in algebraic statistics and logic for  pharmacometrics applications.

Probayes

provide ProBT© which is a powerful modeling, inference, and learning platform inheriting 10 years of experience in the domain of Bayesian probabilistic computing, and ProBT-XL which makes Bayesian models prototyping and testing easier and quicker. It provides a Microsoft Excel graphical user interface to ProBT. Use it to design Bayesian networks while taking advantage of the worksheet environment and the Bayesian programming approach.

PRI

provides a wide range of Study Design (D-optimization), Pharmacokinetic, Pharmacodynamic, and Pharmacometric services performed by internationally recognized experts with experience working within industry, academia, and FDA. The PRI team analyzes clinical trial data and provides clear concise reports allowing faster, better informed decision-making during the drug development process and ensuring fewer queries during the regulatory review process.

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