Melisa Masuda-Herrera, Gilead Sciences - Qepler Summits And Conferences

Melisa Masuda-Herrera

Senior Associate Scientist
Gilead Sciences
USA
Gilead Sciences, Inc. is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines.

Related Sessions:

3rd Annual Extractables &
Leachables Summit 2023

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 13 Jun 2023
  • Virtual,
  • Pharma
Day 2: Wednesday, 14 June 2023
CASE STUDY: Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTC) for Parenteral Extractables and Leachable
  • The ELSIE consortium derived duration-based, non-mutagenic thresholds of toxicological concern (TTCs) for parenteral extractables and leachables substances.
  • The first part of the presentation will provide a brief background on the ELSIE consortium and the ELSIE Risk Management Framework for extractables and leachable assessments.
  • This will be followed by a general overview of the TTC concept and its application to mutagenic and non-mutagenic impurities.
  • A majority of the presentation will then focus on the process for deriving the duration-based TTCs for parenteral E&Ls, including an overview of the ELSIE database, evaluation of the toxicological data used to determine the parenteral point of departuand application of adjustment factors.
View Details
This website stores cookies on your computer. These cookies are used to collect information about how you interact with our website and allow us to remember you. We use this information in order to improve and customize your browsing experience and for analytics and metrics about our visitors both on this website and other media. To find out more about the cookies we use, see our Cookies Policy.