Results 1 to 10 of about 278,908 (190)

Quantitative methods and modeling to assess COVID‐19‐interrupted in vivo pharmacokinetic bioequivalence studies with two reference batches

CPT: Pharmacometrics & Systems Pharmacology, 2022
The coronavirus disease 2019 (COVID‐19) has presented unprecedented challenges to the generic drug development, including interruptions in bioequivalence (BE) studies.
Yuqing Gong, Kairui Feng, Peijue Zhang, Jieon Lee, Yuzhuo Pan, Zhen Zhang, Zhanglin Ni, Tao Bai, Miyoung Yoon, Bing Li, Carol Y. Kim, Lanyan Fang, Liang Zhao   +12 more
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Particle size affects pharmacokinetics of milled oxycodone hydrochloride tablet products following nasal insufflation in nondependent, recreational opioid users

Clinical and Translational Science, 2021
This study assessed the impact of product particle sizes (fine: 106–500 µm; coarse: 500–1000 µm) on oxycodone pharmacokinetics (PK) following nasal insufflation of milled oxycodone extended‐release (ER) abuse‐deterrent (AD) tablets using immediate ...
Saeid Raofi, Minori Kinjo, Dajun Sun, Zhichuan Li, Heather Boyce, Karthika Natarajan, Mitchell Frost, Liang Zhao, Markham Luke, Robert Lionberger, Debra Kelsh, Myong‐Jin Kim   +11 more
doaj   +1 more source

Advancements in the Design and Development of Dry Powder Inhalers and Potential Implications for Generic Development

Pharmaceutics, 2022
Dry powder inhalers (DPIs) are drug–device combination products where the complexity of the formulation, its interaction with the device, and input from users play important roles in the drug delivery.
Abhinav Ram Mohan, Qiang Wang, Sneha Dhapare, Elizabeth Bielski, Anubhav Kaviratna, Liangfeng Han, Susan Boc, Bryan Newman   +7 more
doaj   +1 more source

Heterogeneous treatment effect analysis based on machine‐learning methodology

CPT: Pharmacometrics & Systems Pharmacology, 2021
Heterogeneous treatment effect (HTE) analysis focuses on examining varying treatment effects for individuals or subgroups in a population. For example, an HTE‐informed understanding can critically guide physicians to individualize the medical treatment ...
Xiajing Gong, Meng Hu, Mahashweta Basu, Liang Zhao   +3 more
doaj   +1 more source

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
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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