Showing results (1-10 of 9) with videos related to
Sort By:
Pageof 1
Regulatory Toxicology and Pharmacology : RTP|May 31, 2015
Threshold of toxicological concern (TTC) for developmental and reproductive toxicity of anticancer compoundsBrad Stanard, David G Dolan, William Hanneman, et al.Regulatory Toxicology and Pharmacology : RTP|May 29, 2016
Special endpoint and product specific considerations in pharmaceutical acceptable daily exposure derivationJanet Gould, Courtney M Callis, David G Dolan, et al.Journal of Pharmaceutical Sciences|January 4, 2024
Cell and Gene Therapies: Challenges in Designing Extractables and Leachables Studies and Conducting Safety AssessmentsAdeyma Arroyo, Petra Booij, Getachew Woldemariam, et al.New Biotechnology|August 20, 2018
Introduction of a process mass intensity metric for biologicsKristi Budzinski, Megan Blewis, Philip Dahlin, et al.Critical Reviews in Toxicology|June 15, 2022
Framework for sensitization assessment of extractables and leachables in pharmaceuticalsPatricia Parris, Geraldine Whelan, Anders Burild, et al.PDA Journal of Pharmaceutical Science and Technology|September 15, 2023
Sensitization Assessment of Extractables and Leachables in Pharmaceuticals: ELSIE Database AnalysisPatricia Parris, Geraldine Whelan, Anders Burild, et al.Regulatory Toxicology and Pharmacology : RTP|October 10, 2020
Considerations when deriving compound-specific limits for extractables and leachables from pharmaceutical products: Four case studiesPatricia Parris, Elizabeth A Martin, Brad Stanard, et al.PDA Journal of Pharmaceutical Science and Technology|January 15, 2022
Development of Duration-Based Non-Mutagenic Thresholds of Toxicological Concern (TTCs) Relevant to Parenteral Extractables and Leachables (E&Ls)Melisa J Masuda-Herrera, Joel P Bercu, Thomas H Broschard, et al.Regulatory Toxicology and Pharmacology : RTP|January 30, 2025
Comprehensive extractables and leachables sensitization analysis and practical application of a risk-based approach to sensitization assessment for parenteral drug productsPatricia Parris, Geraldine Whelan, Martyn L Chilton, et al.Pageof 1