M. Kopcha

发表

Monitoring the granulation process in a high shear mixer/granulator: An evaluation of three approaches to instrumentation

M. Kopcha, E. Roland, G. Bubb, 1992 .

Evaluation of Methodology for Assessing Release Characteristics of Thermosoftening Vehicles

K. Tojo, M. Kopcha, N. Lordi, 1990, The Journal of pharmacy and pharmacology.

The future of pharmaceutical quality and the path to get there.

Lawrence X. Yu, Lawrence X Yu, M. Kopcha, 2017, International journal of pharmaceutics.

Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.

Lawrence X. Yu, J. Woodcock, L. Buhse, 2016, International journal of pharmaceutics.

Evaluation of Release from Selected Thermosoftening Vehicles

K. Tojo, M. Kopcha, N. Lordi, 1991, The Journal of pharmacy and pharmacology.

Industry 4.0 for Pharmaceutical Manufacturing: Preparing for the Smart Factories of the Future.

Lawrence X. Yu, Sau Lee, K. Tyner, 2021, International journal of pharmaceutics.

Quality Testing of Difficult-to-Make Prescription Pharmaceutical Products Marketed in the US

J. Woodcock, L. Buhse, M. Kopcha, 2020, JAMA network open.

An Audit of Pharmaceutical Continuous Manufacturing Regulatory Submissions and Outcomes in the US.

S. Chatterjee, Sau Lee, M. Kopcha, 2022, International journal of pharmaceutics.

Lessons from CDER’s Quality Management Maturity Pilot Programs

Neil A. Stiber, L. Buhse, J. Maguire, 2023, The AAPS Journal.

Mechanistic understanding of the performance of personalized 3D-printed cardiovascular polypills: A case study of patient-centered therapy.

A. Zidan, M. Kopcha, A. Alayoubi, 2022, International journal of pharmaceutics.