Publications & Comments

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301 total entries

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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Managing the Risk of Nitrosamine Impurities Pharmaceutical Technology Regulatory Sourcebook

Date of Publication: March 15, 2021

Author(s): Curran, T., Bercu, J.P.

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Enabling the Virtual Human Through Physiologically-based Pharmacokinetic Modeling Pharmaceutical Technology Regulatory Sourcebook

Date of Publication: March 15, 2021

Author(s): Einolf, H.J., Williams, T., Patel, A., Gibson, C., Agrawal, N., Sydor, J.

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