Results 101 to 110 of about 280,132 (308)

Price regulation and generic competition in the pharmaceutical market [PDF]

In March 2003 the Norwegian government implemented yardstick based price regulation schemes on a selection of drugs experiencing generic competition. The retail price cap, termed “index price”, on a drug (chemical substance) was set equal to the average ...
Dalen, Dag Morten, Habeth, Tonje, Strøm, Steinar   +2 more
core  

Hatch–Waxman Reform and Accelerated Market Entry of Generic Drugs: Is Faster Necessarily Better? [PDF]

, 2003
Recently there has been a considerable amount of pressure to accelerate consumer access to generic drugs, which are significantly less expensive than their brand-name counterparts.
Eurek, Sarah E.
core   +1 more source

Icariin Enhances the Enzymatic Activity of N‐acetylgalactosaminidase to Augment Akkermansia Abundance in Gut Microbiota for Improved PD‐1 Blockade Efficacy in Tumor Suppression

Advanced Science, EarlyView.
Icariin promoted the growth of Akk by enhancing the activity of N‐acetylgalactosaminidase (Amuc_0920), which enhanced mucin utilization and provided a favorable nutrient environment for bacterial growth. This icariin‐mediated enrichment of Akk further reshaped the tumor microenvironment and promoted CD8+ T cell infiltration, ultimately synergizing with
Shuangying Qiao, Liu Yang, Haibang Hao, Qiuxia Ding, Feng Ding, Zheng Chen, Jinfang Zhang, Yun He, Meng Li, Jun Xu, Chao Wang, Aiping Lu, Fangfei Li   +12 more
wiley   +1 more source

Is it appropriate to call generic drugs copies and copycats? [PDF]

Indian J Psychiatry, 2023
Andrade C.
europepmc   +1 more source

Stemming the Global Trade in Falsified and Substandard Medicines [PDF]

, 2013
Drug safety and quality is an essential assumption of clinical medicine, but there is growing concern that this assumption is not always correct. Poor manufacturing and deliberate fraud occasionally compromises the drug supply in the United States, and ...
Buckley, Gillian J., Gostin, Lawrence O., Kelley, Patrick W.   +2 more
core   +2 more sources

Quantitative Mass Spectrometry‐Based Biodistribution of Monoclonal Antibodies: An Alternative to Radio‐Biodistribution

Advanced Science, EarlyView.
Monoclonal antibodies are powerful anticancer therapeutics targeting tumor‐associated antigens. Mass spectrometry enables precise and accurate quantification of mAbs in tumor plasma and healthy organs. Unlike ligand binding assay and radioactivity, mass spectrometry does not suffer from matrix effects and labelling artefacts while facilitating method ...
Domenico Ravazza, Sheila Dakhel Plaza, Samuele Cazzamalli, Andrea Ciamarone, Andrea Galbiati, Riccardo Stucchi, Frederik Peissert, Emanuele Puca, Dario Neri, Ettore Gilardoni   +9 more
wiley   +1 more source

Mastering particle size analysis: lessons, challenges, and future directions from the FDA–CRCG workshop

AAPS Open
Particle-size distribution (PSD) measurement is a cornerstone of pharmaceutical development and regulatory assessment, influencing formulation stability, dissolution, product quality, and performance.
Xiaoming Xu, William C. Smith, James E. Polli, Christine L. Plavchak, Bin Qin, Yan Wang, Nicholas Holtgrewe, Sam G. Raney, Andre O’Reilly Beringhs, Yihua Bruce Yu, Marc Taraban, Vishalakshi Krishnan, Anna Schwendeman, Dana C. Hammell, Jeffrey D. Clogston, Alan F. Rawle, Jernej Grmaš, Yousif Ayoub, Bernard Domnic, Rama Subba Reddy, Joseph Duncan, Matthew McGann, Jeff Bodycomb, Carl C. L. Schuurmans, Michiel Hermes, Jonathan G. Mehtala, Prashun Roy, Kevin Lance, Collin Britten, Kiwan Park, Daniel Beach, Matthew Elmer, Keith B. Rodenhausen, Zhen Xu, Haiou Qu, Kai-Wei Wu, Maxwell Korang-Yeboah, Yuan Zou, Ji Li, Alaa H. Abuznait, Colette Quinn, Anabelle Ethier, Kendice Ip, Dinesh Dhamecha, Qi Li, Dongkai Zhu, Rutu Valapil   +46 more
doaj   +1 more source

Identifying Cytokine Motif‐Containing, Immunomodulatory Bacterial Proteins in Human Gut Microbiome

Advanced Science, EarlyView.
By building and constructing HMM (Upper left, blue), the authors identify CMCPs in bacteria genomes and CRC related metagenomes and enriched CRC‐related CMCPs (Upper right, blue). They analyze sequence and structural similarity of hits (Lower left, green), test function with engineered EcN delivered to tumors in a mouse tumor model (Lower right, pink ...
Ziyu Wang, Siqi Guo, Jing Li, Qianqian Huang, Jing Ning, Binbin Xia, Xun Lv, Xiang Liu, Zeyu Gao, Jine Li, Longchao Liu, Moshi Song, Jun Wang   +12 more
wiley   +1 more source

Genetic Control of Tissue Remodeling by a Non‐Coding SNP in ITGA8 Explains Carotenoid‐Based Color Polymorphism in Marine Mollusks

Advanced Science, EarlyView.
In this study, the orange‐muscle giant abalone (Haliotis gigantea) is used as a model to identify a non‐coding SNP that disrupts the interaction between ITGA8 pre‐mRNA and the splicing factor ILF2, leading to altered ITGA8 splicing. These splicing changes promote carotenoid accumulation in abalone muscle through the regulation of tissue remodeling ...
Xiaohui Wei, Wenzhu Peng, Zekun Huang, Bingye Yang, Yiyu Wu, Minzhen Han, Yi Wang, Bingling Peng, Guosheng Hu, Jiawei Hong, Guijia Liu, Linwei Nie, Yang Gan, Miaoqin Huang, Xuan Luo, Weiwei You, Wen Liu, Caihuan Ke   +17 more
wiley   +1 more source

Development and comparison of model‐integrated evidence approaches for bioequivalence studies with pharmacokinetic end points

CPT: Pharmacometrics & Systems Pharmacology
By applying nonlinear mixed‐effect (NLME) models, model‐integrated evidence (MIE) approaches are able to analyze bioequivalence (BE) data with pharmacokinetic end points that have sparse sampling, which is problematic for non‐compartmental analysis (NCA).
Xiaomei Chen, Henrik B. Nyberg, Mark Donnelly, Liang Zhao, Lanyan Fang, Mats O. Karlsson, Andrew C. Hooker   +6 more
doaj   +1 more source