Publications & Comments

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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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