Results 41 to 50 of about 2,001,725 (168)

The DMP atlas for North Rhine-Westphalia, Germany: results of the disease management programmes on district level

Research in Health Services & Regions
Disease Management Programmes (DMP) in Germany were initiated to enhance the quality of ambulatory health care for specific chronic diseases. They aim to prevent the progression of the disease and comorbidity as well as to improve quality of life.
Sabine Groos, Jens Kretschmann, Arne Weber, Michaela Assheuer, Bernd Hagen   +4 more
doaj   +1 more source

A headspace-gas chromatography method for isopropanol determination in warfarin sodium products as a measure of drug crystallinity

Acta Pharmaceutica, 2018
Coumadin® a nd s everal generic products of warfarin s odium (WS) contain the crystalline form (clathrate) in which WS and isopropanol (IPA) are associated in a 2:1 molar ratio. IPA is critical in maintaining the WS crystalline structure. Physicochemical
Rahman Ziyaur, Akhtar Sohail, Siddiqui Akhtar, Ciavarella Anthony B., Nguyenpho Agnes, Faustino Patrick J., Khan Mansoor A.   +6 more
doaj   +1 more source

Innovative approach to support therapeutic proteins’ similarity in hydrodynamic size using high-throughput dynamic light scattering and forced degradation

Scientific Reports
Comparative analytical assessment (CAA) between the reference product and the proposed product forms the basis of the biosimilarity demonstration. Though Dynamic Light Scattering (DLS) has been implemented for CAA, its capability beyond signature peak ...
Ashwinkumar Bhirde, Siri Harish, Nicholas Trunfio, Isabella F. de Luna, William Smith, Qiong Fu   +5 more
doaj   +1 more source

FDA’s implementation of knowledge-aided assessment and structured application for manufacturing assessment of non-sterile solid oral dosage form drug products

AAPS Open
The Knowledge-Aided Assessment and Structured Application (KASA) is an initiative led by the FDA’s Center for Drug Evaluation and Research (CDER) which is launched within CDER’s Office of Pharmaceutical Quality (OPQ). It is a platform designed to conduct
Zhouxi Wang, Jingbo Xiao, Daniel Obrzut, Stelios Tsinontides, Rakhi Shah   +4 more
doaj   +1 more source

Nicotinate-curcumin improves NASH by inhibiting the AKR1B10/ACCα-mediated triglyceride synthesis

Lipids in Health and Disease
Background Nonalcoholic steatohepatitis (NASH) is a prevalent chronic liver condition. However, the potential therapeutic benefits and underlying mechanism of nicotinate-curcumin (NC) in the treatment of NASH remain uncertain. Methods A rat model of NASH
Xiu-lian Lin, Ya-ling Zeng, Jie Ning, Zhe Cao, Lan-lan Bu, Wen-Jing Liao, Zhi-min Zhang, Tan-jun Zhao, Rong-geng Fu, Xue-Feng Yang, Yong-zhen Gong, Li-Mei Lin, De-liang Cao, Cai-ping Zhang, Duan-fang Liao, Ya-Mei Li, Jian-Guo Zeng   +16 more
doaj   +1 more source

A controlled vocabulary and taxonomy for the submission of quality attributes for therapeutic proteins

AAPS Open
Structured product quality data offer tremendous promise to revolutionize the submission of drug applications. However, the quality attributes for biological products do not have a systematic naming taxonomy, and consequently this limit poses a critical ...
Joel T. Welch, Steven Kozlowski, Bazarragchaa Damdinsuren, Brian A. Roelofs   +3 more
doaj   +1 more source

Second-generation lectin microarray for high throughput glycan profiling of therapeutic antibodies

AAPS Open
N-linked glycosylation is a critical quality attribute of therapeutic monoclonal antibodies (mAbs), influencing efficacy, safety, and pharmacokinetics.
Kayla Hess, Helena Yun, Shen Luo, Uriel Ortega-Rodriguez, Grace Henry Lunde, Sarah Rogstad, Lai-Xi Wang, Baolin Zhang   +7 more
doaj   +1 more source

NMR-based structural integrity analysis of therapeutic monoclonal antibodies: a comparative study of Humira and its biosimilars

mAbs
The analytical comparability of biologic products and their biosimilars, including higher-order structure (HOS) assessment, ensures product quality and is required for regulatory approval.
Donna Baldisseri, Shen Luo, Christelle Anne F. Ancajas, Uriel Ortega-Rodriguez, Christian Fischer, Guozhang Zou, Jianghong Gu, David Keire, Martial Piotto, Baolin Zhang   +9 more
doaj   +1 more source

Recent advances in self-targeting natural product-based nanomedicines

Journal of Nanobiotechnology
Natural products, recognized for their potential in disease prevention and treatment, have been integrated with advanced nano-delivery systems to create natural product-based nanomedicines, offering innovative approaches for various diseases.
Haifan Liu, Xingyue Jin, Suyi Liu, Xinyue Liu, Xiao Pei, Kunhui Sun, Meifang Li, Ping Wang, Yanxu Chang, Tiejie Wang, Bing Wang, Xie-an Yu   +11 more
doaj   +1 more source

Effects of Varying Dietary Lipid and Starch Levels on Growth Performance, Biochemical Components, and Hepatic Glycolipid Metabolism in Hybrid Grouper (Epinephelus lanceolatus ♂ × E. fuscoguttatus ♀)

Animals
A 56-day feeding trial was conducted to evaluate the effects of varying dietary lipid and starch levels on growth performance, biochemical components, and hepatic glycolipid metabolism in hybrid grouper.
Songhang Li, Kun Wang, Mengyao Chen, Yuan Li, Chong Wang, Kai Song, Yichuang Xu, Jidan Ye   +7 more
doaj   +1 more source