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International Society of Pharmacometrics (ISOP)
United States
Registrace 30. 07. 2013
The International Society of Pharmacometrics (www.go-isop.org) goal is to promote and advance the discipline of Pharmacometrics and broaden its impact.
(ISoP) seeks the promotion and advancement of the discipline of pharmacometrics, through Integration, Innovation, and Impact: quantitative integration of multisource data and knowledge of clinical, biomedical, biological, engineering, statistical, and mathematical concepts, resulting in continuous methodological and technological innovation enhancing scientific understanding and knowledge, which in turn has an impact on discovery, research, development, approval, and utilization of new therapies.
www.go-isop.org/
(ISoP) seeks the promotion and advancement of the discipline of pharmacometrics, through Integration, Innovation, and Impact: quantitative integration of multisource data and knowledge of clinical, biomedical, biological, engineering, statistical, and mathematical concepts, resulting in continuous methodological and technological innovation enhancing scientific understanding and knowledge, which in turn has an impact on discovery, research, development, approval, and utilization of new therapies.
www.go-isop.org/
Video
Understanding the Impact of Study Design the Role of Model-Informed Development on Dosage Selection
zhlédnutí 69Před 2 měsíci
Understanding the Impact of Study Design the Role of Model-Informed Development on Dosage Selection
Maximizing on Minimal Data using Pharmacometric Modeling to Estimate the Prob. of Technical Success
zhlédnutí 89Před 3 měsíci
Hosted by the SxP SIG and Biopharmaceutical Section of the ASA. sxpsig.github.io/ community.amstat.org/biop/home Speakers: John Prybylski and Min Zhang, Pfizer Dermatomyositis is a rare disease with manifestations in skin and muscle tissues and is considered a type I interferonopathy largely driven by interferon β (IFNβ). While there are several clinical scores used in dermatomyositis, Total Im...
Overview of CDISC ADaM Population PK Data Standard ADPPK Implementation Guide
zhlédnutí 207Před 3 měsíci
Hosted by the PKPD Programming subgroup of the Statistics and Pharmacometrics SIG for ASA and ISoP sxpsig.github.io/ Speakers: Neelima Thanneer (BMS), Fang Li (FDA), Luke Reinbolt (Navitas) Presentation slides and ADPPK Implementation Guide are posted here: sxpsig.github.io/events/pastevents/posts/webinar-19Jan2024.html This Webinar provides an overview of the work done by the ADaM sub-team (AD...
Handling missing covariates in model-based meta-analysis (Use-case for competitive benchmarking)
zhlédnutí 141Před 7 měsíci
Hosted by the MBMA Sub-SIG of the Statistics and Pharmacometrics SIG for ASA and ISoP sxpsig.github.io/ www.linkedin.com/company/isop-model-based-meta-analysis-mbma-sub-sig Model-based meta-analysis (MBMA) is a quantitative approach that leverages summary- and/or individual-level of historical clinical trials to inform key drug development decisions. Missingness is a frequent limitation that we...
Changes to Population PK/PD data and supplemental information based on FDA Guidance for PopPK
zhlédnutí 186Před 8 měsíci
Hosted by the PKPD Programming Subgroup of the Statistics and Pharmacometrics SIG for ASA and ISoP: sxpsig.github.io/ In this presentation the speakers highlight the updates in the latest FDA Guidance for Population PK that impact the PMx Datasets, Report and eSub aspects. They provide some discussion and recommendations on how to incorporate the changes into the submission package. Speakers : ...
The DEM Method for Evaluating Surrogate Endpoints for Accelerated Clinical Development
zhlédnutí 117Před 10 měsíci
The Decision-Equivalence Metric (DEM) method for Evaluating Surrogate Endpoints for Accelerated Clinical Development Using a Combination of Individual Level and Aggregate Level Literature Data Presenters: Chandni Valiathan, John Maringwa and Lixia Pei - Janssen R&D Sponsored by the Statistics and Pharmacometrics Special Interest Group for ASA and ISoP: sxpsig.github.io/ Surrogate endpoints, if ...
Importance of Cultural Sensitivity in Transforming R&D in an International Company
zhlédnutí 45Před rokem
In this webinar, Dr. Frank Douglas discusses three examples of the importance of cultural sensitivity in transforming Research and Development during the formation of Aventis SA (presently Sanofi SA) and one of its predecessor companies. These examples will focus on the challenges of Leadership in the face of opposition above and below the leader, creating a new R&D portfolio by selecting the m...
Three Minute Thesis & Beyond! Short and Effective Technical Communication
zhlédnutí 40Před rokem
This webinar is designed for individuals interested in honing their skills in short and effective communication. Hear from past national winners and re-designers of the Three Minute Thesis Challenge. They share their lessons learned, tricks, and tips for effective and concise communication. Discover how to personalize your communication style and adapt it to your audience's background in this p...
Communicating the Influence Drug Development and Regulatory Decisions: A Tutorial
zhlédnutí 59Před rokem
Pharmacometricians require three skills to be influential: technical, business (e.g., drug development), and soft skills (e.g., communication). Effective communication is required to translate technical and often complicated quantitative findings to interdisciplinary team members in order to influence drug development or regulatory decisions. Join Dr. Gobburu as he highlights important aspects ...
Science Through Story Telling with Dr. Sara ElShafie
zhlédnutí 55Před rokem
This webinar describes how to understand the difference between cognitive and affective professional empathy, understand what type of communication works best for you, and how to successfully interact when fielding questions and objections. Dr. Sara ElShafie is a global change biologist and a science storytelling coach. She is the Founder and Principal of Science Through Story, LLC, dedicated t...
Evaluation of covariate effects using forest plots and introduction to the coveffectsplot R package
zhlédnutí 482Před rokem
Presenter: Samer Mouksassi, Certara Sponsored by the Statistics and Pharmacometrics Special Interest Group for ASA and ISoP: sxpsig.github.io/ The current webinar describes why forest plots are needed for an effective communication of covariates effects, how they are constructed, and how they should be presented. Simulation- based methodologies, using mrgsolve, are presented and allow the user ...
A Gentle Introduction to Optimal Design for Pharmacometric Models
zhlédnutí 582Před rokem
Speaker: Tim Waterhouse, Metrum Research Group Sponsored by the Statistics and Pharmacometrics Special Interest Group for ASA and ISoP: sxpsig.github.io/ Abstract: PK/PD studies should be designed in such a way that the model parameters will be estimated with adequate precision and bias. This can be assessed by simulation, but depending on the study and model(s) involved, it can be impractical ...
Estimands and Causal Inference in Pharmacometrics
zhlédnutí 369Před rokem
Webinar hosted by the Statistics and Pharmacometrics SIG December 8, 2022 sxpsig.github.io/
ADA/Immunogenicity Data Handling
zhlédnutí 900Před 2 lety
Hosted by the PKPD Programming Forum on Sep 9th, 2021. The topic for discussion covers immunogenicity data in large molecule therapeutics from data collection, data handling, dataflow to data analysis and reporting. We would like to take this opportunity to give an overview of development of anti-drug antibody(ADA), interpretation of immunogenicity data, industry practices of structured data in...
Update on CDISC ADaM Population PK Data Standard ADPPK
zhlédnutí 476Před 2 lety
Update on CDISC ADaM Population PK Data Standard ADPPK
The Art and Science of Career Advancement Part 2
zhlédnutí 30Před 2 lety
The Art and Science of Career Advancement Part 2
The Art and Science of Career Advancement Part 1
zhlédnutí 51Před 2 lety
The Art and Science of Career Advancement Part 1
Communicating to Influence Drug Development and Regulatory Decisions: A Tutorial
zhlédnutí 66Před 2 lety
Communicating to Influence Drug Development and Regulatory Decisions: A Tutorial
The Case of the Pharmacometrician’s Pitiful Planning
zhlédnutí 203Před 3 lety
The Case of the Pharmacometrician’s Pitiful Planning
The Case of the Extrapolated Prediction
zhlédnutí 68Před 3 lety
The Case of the Extrapolated Prediction
The Case of the Not So Confirmatory Conclusion
zhlédnutí 50Před 3 lety
The Case of the Not So Confirmatory Conclusion
Use of Berkeley Madonna For QSP Modeling (Dr. Yasong Lu)
zhlédnutí 8KPřed 8 lety
Use of Berkeley Madonna For QSP Modeling (Dr. Yasong Lu)
Some segments in the video are stamped not adjacent to each other
thanks Mr. Lu for the tutorial.