Publications & Comments

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236 total entries

IQ Data Integrity WG Risk Assessment Tool

Date of Publication: August 03, 2020

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2019 IQ Annual Report

Date of Publication: March 27, 2020

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ICH M9 Guideline in Development on Biopharmaceutics Classification System-based Biowaivers: An Industrial Perspective from the IQ Consortium Molecular Pharmaceutics

Date of Publication: December 17, 2019

Author(s): Bransford, P., Cook, J., Gupta, M., Haertter, S., He, H., Ju, R., ... & Wenning, L. (2019). ICH M9 Guideline in Development on Biopharmaceutics Classification System-based Biowaivers: An Industrial Perspective from the IQ Consortium. Molecular Pharmaceutics. Epub.

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Liver Microphysiological Systems Development Guidelines for Safety Risk Assessment in the Pharmaceutical Industry Lab on a Chip

Date of Publication: December 04, 2019

Author(s): Baudy, A.R., Otieno, M.A., Hewitt, P., Gan, J., Roth, A., Keller, D., Sura, R., Van Vleet, T.R., Proctor, W.R. (2019). Liver Microphysiological Systems Development Guidelines for Safety Risk Assessment in the Pharmaceutical Industry. Lab on a Chip. Epub 2019 Dec 4. DOI: 10.1039/C9LC00768G.

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Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug‐induced Liver Injury Occurring during Clinical Trials in Adults with Chronic Cholestatic Liver Disease Alimentary Pharmacology & Therapeutics

Date of Publication: November 25, 2019

Author(s): Palmer, M., Regev, A., Lindor, K., Avigan, M. I., Dimick‐Santos, L., Treem, W., ... & Shneider, B. L. (2020). Consensus Guidelines: Best Practices for Detection, Assessment and Management of Suspected Acute Drug‐induced Liver Injury Occurring during Clinical Trials in Adults with Chronic Cholestatic Liver Disease. Alimentary Pharmacology & Therapeutics, 51(1), 90-109.

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