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Publications & Comments

Search for publications, comments, and IQ presentations using the search bar on the left side of the page, or view recent publications, comments, and presentations by scrolling through the list below.

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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