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Sau L Lee

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Articles 31
Citations 398
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Recent Articles
1.
Srai J, Bauer P, Badman C, Bresciani M, Cooney C, Florence A, et al.
J Pharm Sci . 2024 Apr; 113(7):1701-1710. PMID: 38663498
The last decade has seen Advanced Medicines Manufacturing (AMM) progress from isolated product developments to the creation of industry-academic centres of excellence, regulatory innovation progressing leading to new standards, and...
2.
Tran R, Fraser G, Fisher A, Lee S, Boam A, Tsinontides S, et al.
Int J Pharm X . 2024 Mar; 7:100239. PMID: 38545329
A network of regulatory innovations brings a holistic approach to improving the submission, assessment, and lifecycle management of pharmaceutical quality information in the U.S. This dedicated effort in the FDA's...
3.
Dhillon V, Thomas P, Lee S, Deo P, Fenech M
Int J Mol Sci . 2023 Sep; 24(18). PMID: 37762467
Nutritional imbalances have been associated with a higher risk for cognitive impairment. This study determined the red blood cell (RBC) fatty acid profile of newly diagnosed mild cognitive impairment (MCI)...
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.
Hochhaus G, Chen M, Kurumaddali A, Schilling U, Jiao Y, Drescher S, et al.
AAPS J . 2021 Nov; 24(1):1. PMID: 34811595
No abstract available.
6.
Ananthakrishna R, Lee S, Foote J, Sallustio B, Binda G, Mangoni A, et al.
Am Heart J . 2021 Jun; 240:101-113. PMID: 34175315
Background: The presence and extent of left ventricular hypertrophy (LVH) is a major determinant of symptoms in patients with hypertrophic cardiomyopathy (HCM). There is increasing evidence to suggest that myocardial...
7.
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...
8.
Hochhaus G, Chen M, Kurumaddali A, Schilling U, Jiao Y, Drescher S, et al.
AAPS J . 2021 Mar; 23(3):48. PMID: 33768368
In the context of streamlining generic approval, this study assessed whether pharmacokinetics (PK) could elucidate the pulmonary fate of orally inhaled drug products (OIDPs). Three fluticasone propionate (FP) dry powder...
9.
Fisher A, Kamga M, Agarabi C, Brorson K, Lee S, Yoon S
Trends Biotechnol . 2018 Sep; 37(3):253-267. PMID: 30241924
There is a trend across the pharmaceutical sector toward process intensification and continuous manufacturing to produce small-molecule drugs or biotechnology products. For biotechnology products, advancing the manufacturing technology behind upstream...
10.
Nasr M, Krumme M, Matsuda Y, Trout B, Badman C, Mascia S, et al.
J Pharm Sci . 2017 Jun; 106(11):3199-3206. PMID: 28655487
Continuous manufacturing plays a key role in enabling the modernization of pharmaceutical manufacturing. The fate of this emerging technology will rely, in large part, on the regulatory implementation of this...