By Yvonne Will, J. Eric McDuffie, Andrew J. Olaharski, Brandon D. Jeffy
As a consultant for pharmaceutical execs to the problems and practices of drug discovery toxicology, this booklet integrates and stories the tactic and alertness of instruments and techniques at each one step of the drug discovery technique.
- courses researchers as to what drug security experiments are either sensible and necessary- Covers a number of key subject matters - security lead optimization, in vitro-in vivo translation, organ toxicology, ADME, animal versions, biomarkers, and -omics instruments- Describes what experiments are attainable and beneficial and gives a view into the long run, indicating key components to observe for brand new predictive tools- beneficial properties contributions from firsthand event, giving readers perception into the method and execution of predictive toxicology practices
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Extra info for Drug Discovery Toxicology: From Target Assessment to Translational Biomarkers
Ewart L, Aylott M, Deurinck M, Engwall M, Gallacher DJ, Geys H, Jarvis P, Ju H, Leishman D, Leong L, McMahon N, Mead A, Milliken P, Suter W, Teisman A, Van Ammel K, Vargas HM, Wallis R and Valentin JP (2014) The concordance between nonclinical and phase I clinical cardiovascular assessment from a cross‐company data sharing initiative. Toxicol Sci. 142(2):427–35. Fermini B, Hancox JC, Abi‐Gerges N, Bridgland‐Taylor M, Chaudhary KW, Colatsky T, Correll K, Crumb W, Damiano B, Erdemli G, Gintant G, Imredy J, Koerner J, Kramer J, Levesque P, Li Z, Lindqvist A, Obejero‐Paz CA, Rampe D, Sawada K, Strauss DG, Vandenberg JI (2015) A new perspective in the field of cardiac safety testing through the comprehensive in vitro proarrhythmia assay paradigm.
Sponsors may select from a wide range of in vivo and in vitro test systems to identify adverse pharmacodynamic and/or pathophysiological effects and the mechanism(s) by which these effects are produced. Supplemental safety data can also be generated as needed for other organ systems, including renal/urinary, the autonomic nervous system, the gastrointestinal system, and others, when there may be reasons for concern. Compliance with the principles of good laboratory practices (GLP) is generally required in the conduct of these studies, to ensure the reliability and quality of the data obtained, with justification for any safety phar macology and follow‐up studies not conducted under GLP.
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