Leadership
Groups

Life Sciences
Working Groups

CMC
Working Groups

Cross-Disciplinary
Working Groups

Archived Groups

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.

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.

View Publication

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.

View Publication

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.

View Publication

Managing the Risk of Nitrosamine Impurities Pharmaceutical Technology Regulatory Sourcebook

Date of Publication: March 15, 2021

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

View Publication

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.

View Publication