Title: Pharmacometric Programming
Presenters: Amit Roy, Jing Su, Neelima Thanneer, and Jeffry Florian
Date and Time: Tuesday, January 30, 2018, 12:00 p.m. – 1:30 p.m. Eastern time
Sponsor: Section for Statistical Programmers and Analysts
Registration Deadline: Friday, January 26, at 12:00 p.m. Eastern time
Pharmacometrics is an emerging science defined as the science that quantifies drug, disease and trial information to aid efficient drug development and/or regulatory decisions. Pharmacometric Programming specializes in creating modeling-ready datasets for Pharmacometric analyses. After this webinar, participants will learn the difference between Pharmacometrics programming and statistical programming, understand the challenges and strategies of Pharmacometrics programming, and know how to effectively communicate modeling and simulation work to the agency through e-submission of Pharmacometic datasets and reports.
This webinar will present with the following components:
- Introduction to Pharmacometrics and Importance of Pharmacometric Programming — Amit Roy, Bristol-Myers Squibb
The types of Pharmacometrics models will be reviewed, and examples of their use will be presented, along with a discussion of the varied data set requirements for these models, ranging from individual level repeated measures experimental data to summary level data gleaned from the literature. The challenges in assembling quality data sets for the various types of models, and analysis software will also be reviewed.
- Challenges and Strategies in Pharmacometric Programming — Jing Su, Merck & Co., Inc.
At this presentation, the challenges during Pharmacometrics programming will be explained in details and the strategies to overcome them will be discussed. This presentation will also highlight the differences between statistical programming and Pm programming.
Data Standards for Pharmacometric Analysis Data Sets — Neelima Thanneer, Bristol-Myers Squibb
This presentation will describe the data standards to handle issues related to missing and inadequate data. Improvements to CRF design to better capture the required information for pharmacometric analysis and update on International Society of Pharmacometrics [ISoP] data standards for population PK datasets.
Electronic Submission Of Pharmacometrics Data Sets And Reports For Regulatory Submissions — Jeffry Florian, FDA
This presentation will provide an overview on expectations from the FDA regarding the submission of modeling and simulation analyses to support regulatory decision making. Specifically, the talk will focus on format and content of pharmacometrics data sets for regulatory submission, communications prior to and during reviews, and expectations of documentations within pharmacometric reports.
We will conclude with a Q&A session.
Member of the Section for Statistical Programmers and Analysts: $0
ASA Member: $59
Each registration is allowed one connection to the webinar. Multiple persons are encouraged to view each registered connection (for example, by projecting the webinar in a conference room).
Registered persons will be sent an email the afternoon of Friday, January 26, with the access information to join the webinar and the link to download and print a copy of the presentation slides.