PPT-Estimating the dose-toxicity curve from completed Phase I studies

Alexia Iasonos Irina Ostrovnaya Department of Biostatistics Memorial Sloan Kettering Cancer Center CRM Workshop October 2009 Motivation Retrospective analysis of completed Phase I studies in order to recommend possibly a new MTD . View across Swiftcurrent Lake. Acute Toxicity. Recognizing, defining and measuring the effects of chemicals in organisms. “. If you want to explain each poison correctly, what is there that is not poison? All things are poison and nothing without poison. . 2. US National Institutes of Health, . National Library of Medicine (NIH/NLM). on-line . Toxicology Course. I. Basics. II. Toxicokinetics. III. Cellular Toxicology. http://sis.nlm.nih.gov/enviro/toxtutor.html. oncology. Shu-Fang Hsu Schmitz. University of Bern, Bern, Switzerland . Phase I trials . First in human. Ever first in human, or for a specific indication, or for a specific combination . treatment, or for a specific dosing schedule. Chemical . Mixtures. Thomas Backhaus. University of Gothenburg. thomas.backhaus@dpes.gu.se. Chemical Mixtures. Mixtures of toxic chemicals. Aquatic Ecosystems. Ecotoxicology. Focus. PREDICT. BEAM. ACE. . Hong Li. (Acknowledgement: some slides from Rick Chappell, . Univ. of . Wisc. ). Historically, DOSE FINDING study. Determine maximal tolerated dose (MTD). Recommend dose for Phase II clinical trials. According to the . PMBOK. ®. Guide, . Project Cost Management knowledge area includes the processes involved in planning, estimating, budgeting, financing, funding, managing, and controlling costs to complete the project within the approved budget. . KWWOA. April 09, 2014. Department for Environmental Protection. Environmental & Public Protection Cabinet. To Protect and Enhance Kentucky’s Environment. 2. Whole Effluent Toxicity . The aggregate toxic effect of an effluent measured directly by a toxicity test.. Sumathi Nambiar MD MPH. Director. Division of Anti-Infective Products. November 7, 2016. Outline. General considerations with clinical trials early in development. Predictable and unpredictable adverse reactions. 2. US National Institutes of Health, . National Library of Medicine (NIH/NLM). on-line . Toxicology Course. I. Basics. II. Toxicokinetics. III. Cellular Toxicology. http://sis.nlm.nih.gov/enviro/toxtutor.html. Original Data. Equated Day . Factors. Holiday Factors. Normalized Data. Initial Seasonal Factors. Seasonally-Adjusted Data:. Initial. Seasonally-Adjusted Data:. Initial. Growth Rate. (Adjustments). Events. FOR BIS(2 - ETHYLHEXYL)ADIPATE (DEHA) Contract No. CPSC - D - 17 - 0001 Task Order No. 003 Prepared by: Risk Science Center Department of Environmental Health University of Cincinnati 160 Panzeca . Dr. Ghaith Ali Jasim. PhD Pharmacology. . OPIATES: Alkaloid found as a natural product in . Papaver. . somniferum. (Poppy. ), un-ripened seed pods. . . . NARCOTIC: Broader group of agents and is predominantly used by law enforcement to designate a variety of controlled substances with . B.Pharm. . Sixth Sem.. BP602T. Subacute Toxicity. Subacute toxicity studies are intended to evaluate a drug's toxic potential and pathological effects following a treatment/. repeated administration. ToxCast data to predict acute toxicity. Dan Wilson, PhD, DABT. Science Leader – Cheminformatics. The Dow Chemical . Company. ddwilson@dow.com. (989)636-0712. EPA’s Computational Toxicology Communities of Practice.