Michael Kopcha
Overview
Explore the profile of Michael Kopcha including associated specialties, affiliations and a list of published articles.
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Articles
8
Citations
79
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0
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Recent Articles
1.
Sierra-Vega N, Ashraf M, OConnor T, Kopcha M, Prima M, Coburn J, et al.
Int J Pharm
. 2025 Mar;
673:125415.
PMID: 40023346
Three-dimensional (3D) printing is an emerging technology with the potential to increase manufacturing flexibility and enable personalized drug delivery. 3D printing may form tablets using digitally controlled layer-by-layer material deposition,...
2.
Maguire J, Fisher A, Harouaka D, Rakala N, Lundi C, Yambot M, et al.
AAPS J
. 2023 Jan;
25(1):14.
PMID: 36627496
Between October 2020 and March 2022, FDA's Center for Drug Evaluation and Research (CDER) completed two pilot programs to assess the quality management maturity (QMM) of drug manufacturing establishments. Mature...
3.
Wood E, Tatke A, Viehmann A, Ashtiani M, Friedman R, Kopcha M, et al.
Int J Pharm
. 2022 Aug;
625:122119.
PMID: 36029995
An international sampling study yielded 69 samples of extended-release prescription pharmaceuticals for legal sale in the U.S. Samples included 29 lots of innovator and 40 lots of generic solid oral...
4.
Fisher A, Liu W, Schick A, Ramanadham M, Chatterjee S, Brykman R, et al.
Int J Pharm
. 2022 May;
622:121778.
PMID: 35500688
Continuous manufacturing (CM) sends materials directly and continuously to the next step of a process, eliminating hold times and reducing processing times. The potential benefits of CM include improved product...
5.
Alayoubi A, Zidan A, Asfari S, Ashraf M, Sau L, Kopcha M
Int J Pharm
. 2022 Feb;
617:121599.
PMID: 35182706
The 3D printing has become important in drug development for patient-centric therapy by combining multiple drugs with different release characteristics in a single polypill. This study explores the critical formulation...
6.
Arden N, Fisher A, Tyner K, Yu L, Lee S, Kopcha M
Int J Pharm
. 2021 Apr;
602:120554.
PMID: 33794326
Over the last two centuries, medicines have evolved from crude herbal and botanical preparations into more complex manufacturing of sophisticated drug products and dosage forms. Along with the evolution of...
7.
Fisher A, Viehmann A, Ashtiani M, Friedman R, Buhse L, Kopcha M, et al.
JAMA Netw Open
. 2020 Aug;
3(8):e2013920.
PMID: 32833019
Importance: Health care practitioners and patients must have information to support their confidence in the quality of prescription pharmaceuticals. Objective: To determine whether there were clear and substantive differences in...
8.
Yu L, Kopcha M
Int J Pharm
. 2017 Jun;
528(1-2):354-359.
PMID: 28619448
While six sigma quality has long been achieved in other industries, it is rarely seen in the pharmaceutical sector. However, consumers and patients deserve six sigma quality pharmaceuticals with minimal...
9.
Fisher A, Lee S, Harris D, Buhse L, Kozlowski S, Yu L, et al.
Int J Pharm
. 2016 Nov;
515(1-2):390-402.
PMID: 27773853
Failures surrounding pharmaceutical quality, particularly with respect to product manufacturing issues and facility remediation, account for the majority of drug shortages and product recalls in the United States. Major scientific...