Understanding and predicting dose dependent and idiosyncratic events

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Reasons for Termination of Programs due to Safety by Organ System 4
Posted: 5:17 p.m. Friday, Nov. 4, 2016 The Associated Press WASHINGTON — Cempra is one of a h<strong>and</strong>ful of drugmakers developing new antibiotics amid growing bacterial resistance to decades-old drugs like penicillin. On Wednesday Cempra shares plunged more than 60 percent after the FDA posted an online review highlighting irregular liver enzyme measurements reported with the drug, called solithromycin…….. Copyright The Associated Press
Page 1 and 2: ® Modeling Hepatoxicity: Understan
Page 3: Outline of Talk 1). Problem of live
Page 7 and 8: UNC Institute for Drug Safety Scien
Page 9 and 10: Approach 1). Build mechanistic “m
Page 11 and 12: Outline of Talk 1). Problem of drug
Page 13 and 14: Drugs Can Inhibit Bile Acid Transpo
Page 15 and 16: AMG 009 No evidence of liver injury
Page 17 and 18: Modeling in vitro transporter inhib
Page 19 and 20: DILIsym ® Predicts Dose-Dependent
Page 21 and 22: AMG 853 • AMG 853 was the backup
Page 23 and 24: Why mechanism of transport inhibiti
Page 25: Posted: 5:17 p.m. Friday, Nov. 4, 2
Page 28 and 29: Two issues with solithromycin: - Im
Page 30 and 31: DILIsym ® Mechanism-Based Modeling
Page 32 and 33: Contribution to Predicted ALT eleva
Page 34 and 35: Contribution to Predicted ALT eleva
Page 36 and 37: FDA panel narrowly backs Cempra ant
Page 38 and 39: Multiple Steps Involved in Idiosync
Page 40 and 41: Multiple Steps Involved in Idiosync
Page 42 and 43: Summary New mechanistic biomarkers
Page 44 and 45: DILIsym ® Mechanism-Based Modeling
Page 46 and 47: Confidence in Predictions Depends o
Page 48 and 49: Conclusion Quantitative Systems Pha
Page 50 and 51: Special thanks to the DILIsim Partn
Page 52 and 53: Back up

Understanding and predicting dose dependent and idiosyncratic events

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