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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.

408 total entries

Drug Discovery through Commercialization: Industry Collaboration in the Age of COVID-19 and Beyond

Date of Publication: July 02, 2021

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Concordance of 3 alternative teratogenicity assays with results from corresponding embryo fetal development studies: final report from the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ) DruSafe Working Group 2 Regulatory Toxicology Pharmacology

Date of Publication: July 01, 2021

Author(s): M McNerney, D Potter, K Augustine-Rauch, P Barrow, B Beyer, K Brannen, S Engel, B P Enright, W S Nowland, N Powles-Glover, S Powlin, M J Schneidkraut, D Stanislaus, K Turner, M Graziano

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Collaborative Efforts Address Key Data Integrity Challenges Pharmaceutical Technology Regulatory Sourcebook

Date of Publication: March 15, 2021

Author(s): Mohan, G., Turner, C., O’Connor, D., Fink, L., Purdue, T., Beebie, J., Robles, K., Waetjen, K.

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Extrapolating Data from Adult Clinical Trials to Advance Pediatric Drug Development Pharmaceutical Technology Regulatory Sourcebook

Date of Publication: March 15, 2021

Author(s): Haertter, S., Cheung, A., James, A., Strougo, A., Bucci-Rechtweg, C., Liu, J., Tao, M., Ravenstijn, P., Bishai, R., Suryawanshi, S., Corriol-Rohou, S.

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Overcoming Challenges to Biopharmaceutical Development and Manufacture with Science-and Risk-based Strategies Pharmaceutical Technology Regulatory Sourcebook

Date of Publication: March 15, 2021

Author(s): Ramdas, S., Varga, R., Gastens, M., Christian, T.R., Jagannathan, B., Rellahan, B., Brady, J.

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