Woodcock, Janet

Understanding pharmaceutical quality by design

Yu, L. X., Amidon, G., Khan, M. A., Hoag, S. W., Polli, J., Raju, G. K., & Woodcock, J. (2014) · The AAPS Journal

Analytical Methods in PharmaceuticalsPharmaceutical studies and practices

Cited by 1,475

Real-world evidence and real-world data for evaluating drug safety and effectiveness.

Corrigan-Curay, J., Sacks, L., & Woodcock, J. (2018) · JAMA

Pharmacovigilance and Adverse Drug ReactionsPharmaceutical Economics and Policy

Cited by 471

Advancing the Science for Active Surveillance: Rationale and Design for the Observational Medical Outcomes Partnership

Stang, P. E., Ryan, P. B., Racoosin, J. A., Overhage, J. M., Hartzema, A. G., Reich, C., Welebob, E., Scarnecchia, T., & Woodcock, J. (2010) · Annals of Internal Medicine

Pharmacovigilance and Adverse Drug ReactionsData-Driven Disease Surveillance

Cited by 441

New FDA Regulation to Improve Safety Reporting in Clinical Trials

Behrman Sherman, R., Woodcock, J., Norden, J., Grandinetti, C., & Temple, R. J. (2011) · New England Journal of Medicine

Pharmacovigilance and Adverse Drug ReactionsPharmaceutical industry and healthcare

Cited by 50

Advancing product quality: a summary of the second FDA/PQRI conference

Yu, L. X., Akseli, I., Allen, B., Amidon, G., Bizjak, T. G., Boam, A., Caulk, M., Doleski, D., Famulare, J., Fisher, A. C., et al. (2016) · The AAPS Journal

Pharmaceutical Economics and PolicyHealthcare Regulation

Cited by 33

FDA Regulations for Drug Development

Behrman, R. E., & Woodcock, J. (2010) · Science

Biomedical Ethics and RegulationHealthcare Regulation

Cited by 8