Results 11 to 20 of about 4,484,991 (333)

Global harmonization of immediate‐release solid oral drug product bioequivalence recommendations and the impact on generic drug development

Clinical and Translational Science, 2023
Immediate‐release (IR) solid oral drug products constitute a significant portion of approved drug products and products under development. Bioequivalence (BE) assessment for these oral products is important for establishing therapeutic equivalence for ...
Joseph Kotsybar, Susan Hakeem, Lei Zhang, Wenlei Jiang   +3 more
doaj   +1 more source

“Petal-like” size-tunable gold wrapped immunoliposome to enhance tumor deep penetration for multimodal guided two-step strategy

Journal of Nanobiotechnology, 2021
Background Breast cancer is the fastest-growing cancer among females and the second leading cause of female death. At present, targeted antibodies combined with hyperthermia locally in tumor has been identified as a potential combination therapy to ...
Yanan Li, Wenting Song, Yumin Hu, Yun Xia, Zhen Li, Yang Lu, Yan Shen   +6 more
doaj   +1 more source

Characterizing the Physicochemical Properties of Two Weakly Basic Drugs and the Precipitates Obtained from Biorelevant Media

Pharmaceutics, 2022
Generally, some weakly basic insoluble drugs will undergo precipitate and redissolution after emptying from the stomach to the small intestinal, resulting in the limited ability to predict the absorption characteristics of compounds in advance ...
Miao Zhang, Bin Wu, Shudong Zhang, Lin Wang, Qin Hu, Dongyang Liu, Xijing Chen   +6 more
doaj   +1 more source

A polyoxyethylene sorbitan oleate modified hollow gold nanoparticle system to escape macrophage phagocytosis designed for triple combination lung cancer therapy via LDL-R mediated endocytosis

Drug Delivery, 2020
Presently, a combination of chemotherapy, radiotherapy, thermotherapy, and other treatments has become a hot topic of research for the treatment of cancer, especially lung cancer.
Yan Shen, Yun Xia, Ershuang Yang, Zixuan Ye, Yuan Ding, Jiasheng Tu, Yong Zhang, Pengcheng Xu   +7 more
doaj   +1 more source

Enhanced cytotoxicity of a redox-sensitive hyaluronic acid-based nanomedicine toward different oncocytes via various internalization mechanisms

Drug Delivery, 2020
Receptor-mediated active targeting and tumor microenvironment responsive systems from polymeric micelles have been studied for rapid cellular internalization and triggered drug release.
Yunai Du, Sheng Wang, Tianhao Zhang, Dongsheng He, Jiasheng Tu, Yan Shen   +5 more
doaj   +1 more source

Similarities and Differences of International Practices and Procedures for the Regulation for Active Substance Master Files/Drug Master Files of Human Use: Moving Toward Regulatory Convergence

Journal of Pharmacy & Pharmaceutical Sciences, 2016
Purpose. A gap analysis survey of international practices for Active Substance Master Files (ASMFs)/Drug Master Files (DMFs) of human use was conducted as a project of the ASMF/DMF working group of the International Generic Drug Regulators Pilot (IGDRP ...
Maki Matsuhama, Tomoko Takishita, Ryosuke Kuribayashi, Kazunori Takagi, Rika Wakao, Kenichi Mikami   +5 more
doaj   +1 more source

Information Extraction From FDA Drug Labeling to Enhance Product-Specific Guidance Assessment Using Natural Language Processing

Frontiers in Research Metrics and Analytics, 2021
Towards the objectives of the UnitedStates Food and Drug Administration (FDA) generic drug science and research program, it is of vital importance in developing product-specific guidances (PSGs) with recommendations that can facilitate and guide generic ...
Yiwen Shi, Ping Ren, Yi Zhang, Xiajing Gong, Meng Hu, Hualou Liang   +5 more
doaj   +1 more source

Generic Drugs Not as Safe as FDA Wants You to Believe

The Annals of Pharmacotherapy, 2020
Food and Drug Administration (FDA) rules for the production of prescription drugs are very rigorous and, if followed, guarantees a safe drug supply.
C. Michael White
semanticscholar   +1 more source

Regulatory utility of physiologically based pharmacokinetic modeling for assessing food impact in bioequivalence studies: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
This workshop report summarizes the presentations and panel discussion related to the use of physiologically based pharmacokinetic (PBPK) modeling approaches for food effect assessment, collected from Session 2 of Day 2 of the workshop titled “Regulatory
Abdullah Al Shoyaib, Arian Emami Riedmaier, Anita Kumar, Partha Roy, Neil John Parrott, Lanyan Fang, Nilufer Tampal, Yuching Yang, Rebeka Jereb, Liang Zhao, Fang Wu   +10 more
doaj   +1 more source

Mechanistic modeling of ophthalmic, nasal, injectable, and implant generic drug products: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
For approval, a proposed generic drug product must demonstrate it is bioequivalent (BE) to the reference listed drug product. For locally acting drug products, conventional BE approaches may not be feasible because measurements in local tissues at the ...
Ming‐Liang Tan, Sajeev Chandran, Rebeka Jereb, Khondoker Alam, Robert Bies, Darby Kozak, Ross Walenga, Maxime Le Merdy, Andrew Babiskin   +8 more
doaj   +1 more source