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1.
Red Blood Cell Fatty Acid Profiles Are Significantly Altered in South Australian Mild Cognitive Impairment and Alzheimer's Disease Cases Compared to Matched Controls.
Int J Mol Sci
; 24(18)2023 Sep 15.
Artículo
en Inglés
| MEDLINE | ID: mdl-37762467
2.
Randomized controlled trial of perhexiline on regression of left ventricular hypertrophy in patients with symptomatic hypertrophic cardiomyopathy (RESOLVE-HCM trial).
Am Heart J
; 240: 101-113, 2021 10.
Artículo
en Inglés
| MEDLINE | ID: mdl-34175315
3.
The influence of secondary processing on the structural relaxation dynamics of fluticasone propionate.
AAPS PharmSciTech
; 16(3): 589-600, 2015 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-25398478
4.
A network of regulatory innovations to improve FDA quality assessments of human drug applications.
Int J Pharm X
; 7: 100239, 2024 Jun.
Artículo
en Inglés
| MEDLINE | ID: mdl-38545329
5.
Emerging applications and regulatory strategies for advanced medicines manufacturing - Towards the development of a platform approach.
J Pharm Sci
; 2024 Apr 23.
Artículo
en Inglés
| MEDLINE | ID: mdl-38663498
6.
An audit of pharmaceutical continuous manufacturing regulatory submissions and outcomes in the US.
Int J Pharm
; 622: 121778, 2022 Jun 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-35500688
7.
Industry 4.0 for pharmaceutical manufacturing: Preparing for the smart factories of the future.
Int J Pharm
; 602: 120554, 2021 Jun 01.
Artículo
en Inglés
| MEDLINE | ID: mdl-33794326
8.
Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?
AAPS J
; 23(3): 48, 2021 03 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-33768368
9.
The Current Scientific and Regulatory Landscape in Advancing Integrated Continuous Biopharmaceutical Manufacturing.
Trends Biotechnol
; 37(3): 253-267, 2019 03.
Artículo
en Inglés
| MEDLINE | ID: mdl-30241924
10.
Liposomal Drug Product Development and Quality: Current US Experience and Perspective.
AAPS J
; 19(3): 632-641, 2017 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-28160164
11.
Development Considerations for Nanocrystal Drug Products.
AAPS J
; 19(3): 642-651, 2017 05.
Artículo
en Inglés
| MEDLINE | ID: mdl-28281194
12.
Building parity between brand and generic peptide products: Regulatory and scientific considerations for quality of synthetic peptides.
Int J Pharm
; 518(1-2): 320-334, 2017 Feb 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-28027918
13.
The evolving landscape of drug products containing nanomaterials in the United States.
Nat Nanotechnol
; 12(6): 523-529, 2017 07.
Artículo
en Inglés
| MEDLINE | ID: mdl-28436961
14.
Regulatory Perspectives on Continuous Pharmaceutical Manufacturing: Moving From Theory to Practice: September 26-27, 2016, International Symposium on the Continuous Manufacturing of Pharmaceuticals.
J Pharm Sci
; 106(11): 3199-3206, 2017 11.
Artículo
en Inglés
| MEDLINE | ID: mdl-28655487
15.
Emerging technology: A key enabler for modernizing pharmaceutical manufacturing and advancing product quality.
Int J Pharm
; 509(1-2): 492-498, 2016 Jul 25.
Artículo
en Inglés
| MEDLINE | ID: mdl-27260134
16.
Advancing pharmaceutical quality: An overview of science and research in the U.S. FDA's Office of Pharmaceutical Quality.
Int J Pharm
; 515(1-2): 390-402, 2016 Dec 30.
Artículo
en Inglés
| MEDLINE | ID: mdl-27773853
17.
Correction to: Can Pharmacokinetic Studies Assess the Pulmonary Fate of Dry Powder Inhaler Formulations of Fluticasone Propionate?
AAPS J
; 24(1): 1, 2021 Nov 22.
Artículo
en Inglés
| MEDLINE | ID: mdl-34811595
18.
Current Scientific and Regulatory Approaches for Development of Orally Inhaled and Nasal Drug Products: Overview of the IPAC-RS/University of Florida Orlando Inhalation Conference.
AAPS J
; 17(5): 1305-11, 2015 Sep.
Artículo
en Inglés
| MEDLINE | ID: mdl-26033698
19.
Product quality for nanomaterials: current U.S. experience and perspective.
Wiley Interdiscip Rev Nanomed Nanobiotechnol
; 7(5): 640-54, 2015.
Artículo
en Inglés
| MEDLINE | ID: mdl-25641690
20.
Application of the modified chi-square ratio statistic in a stepwise procedure for cascade impactor equivalence testing.
AAPS J
; 17(2): 370-9, 2015 Mar.
Artículo
en Inglés
| MEDLINE | ID: mdl-25515206