This workshop will equip participants with the skills and knowledge necessary to excel in non-compartmental analysis (NCA). NCA is a method to describe pharmacokinetic data used to assess how a drug behaves in the body. It provides key insights into a drug’s absorption, distribution, metabolism, and elimination. By examining parameters like maximum concentration (Cmax), area under the curve (AUC), and half-life, researchers can determine drug exposure and clearance, aiding in drug development and dosing optimization.
Workshop outline: The workshop will be comprised of
- Introduction to PKNCA
- Requirements of PKNCA Data Sets
- Introduction to the Main Functions Used by PKNCA
- Perform a Typical Noncompartmental Analysis with PKNCA
- Hands-On Session – NCA on Data from a Killer Whale and a Beluga Whale
- Data Details: Excluding Data Overall or Just for Half-Life
- Performing Installation Qualification Validation of PKNCA
- Hands-On Session – NCA for a Combination Single- and Multiple-Ascending Dose Study
Attendee Requirements: All interested attendees will need to apply through the Google form.
Other requirements include – 100% attendance and submitting the assignment by the due date.
Application Link:
https://forms.gle/y2svbQhqPkvJcNa79
Bill Denney Ph.D.
Dr. Denney founder and CEO of Human Predictions and has over 20 years of experience in mathematical modeling. Prior to starting Human Predictions, Bill was a Director of Clinical Pharmacology at Pfizer. In this position, he developed pharmacometric tools and models to enhance transparency and understanding of internal development compounds. Prior to Pfizer, Bill worked at Merck in the Clinical PK/PD department.
Throughout his time in the pharmaceutical industry, Bill has called on his decade of computer science and information technology experience to build quality and efficiency into his analyses and designs. Bill received his Ph.D. and Master’s degree from the University of Pennsylvania in Chemical and Biomolecular Engineering and his Bachelor’s of Science (with high honors) from the Georgia Institute of Technology.
Workshop Agenda
● Introduction to PKNCA
○ Overview of PKNCA
○ Importance of PKNCA in pharmacology
● Requirements of PKNCA Data Sets
○ Types of data needed for PKNCA
○ Ensuring data quality and integrity
● Introduction to the Main Functions Used by PKNCA
○ Overview of essential PKNCA analysis functions
○ Practical applications of PKNCA software
● Perform a Typical Noncompartmental Analysis with PKNCA
○ Understanding the principles of NCA
○ Steps for a typical NCA
● Hands-On Session – NCA on Data from a Killer Whale and a Beluga Whale
○ Analyzing pharmacokinetic data from killer whales and beluga whales
○ Interpreting NCA results
● Excluding Data Overall or Just for Half-Life
○ Strategies for excluding data points
○ Practical examples, including half-life calculations
● Performing Installation Qualification Validation of PKNCA
○ Ensuring proper setup and validation of PKNCA software
○ Compliance and quality assurance considerations
● Hands-On Session – NCA for a Combination Single- and Multiple-Ascending Dose Study
○ Applying NCA techniques to combination study data
○ Summary of key takeaways
Sponsored by:
PharmaPro Consulting is a distinguished unique firm renowned for its elite pharmaceutical talent pool. Specializing in Clinical Pharmacology, Pharmacometrics, Regulatory Affairs, Medical, and Manuscript Writing, they offer strategic consulting services to pharmaceutical, biotechnology firms, and government entities. With a formidable team of 40+ experts, many boasting over two decades of drug development expertise spread across six countries, PharmaPro has provided invaluable support to 20+ clients in the last seven years. Notable clients include Moderna, JnJ, Genentech, Roche, Novartis, and Daiichi Sankyo, among others. PharmaPro Consulting stands poised as a transformative force for any organization seeking excellence in pharmaceutical endeavors.
Gilead is a company with more than 18,000 employees across six continents, Gilead has a global workforce dedicated to creating a better, healthier world for everyone. They have designed an Early Talent Program with purpose-driven students and new professionals at the core and their goal is to enable their professional development by providing opportunities to contribute to best-in-class science, play a role in transformative business developments, and work alongside some of the brightest minds across our industry.
Human Predictions is a company focusing on pharmacometrics and clinical pharmacology analysis. They specialize in integrating many sources and types of data to increase the precision of your knowledge. The company has experience helping decision makers and clinical development teams with clinical development strategy, regulatory interactions and filings, in-licensing and out-licensing, clinical and nonclinical study design, and comparing the standard of care to novel therapeutics. The team works with you to focus drug development with efficient experiments, to perform novel analyses, and to convert unconnected data into actionable knowledge.
Hosted by:
Project Dontabhaktuni is a non-profit organization created to support scientists and students from around the world. The goal of “Project Dontabhaktuni” is to create training and mentoring programs for students and scientists all over the world who would like to expand their knowledge in drug development, particularly in pharmacometrics, leading to expediting drug development, appropriate drug therapy, and better patient outcomes. In the past 3 years, we have trained over 2000 scientists from 40 countries through onsite and online workshops.
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