Results 11 to 20 of about 351,529 (205)

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
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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

Regulatory utility of mechanistic modeling to support alternative bioequivalence approaches: A workshop overview

CPT: Pharmacometrics & Systems Pharmacology, 2023
On September 30 and October 1, 2021, the US Food and Drug Administration (FDA) and the Center for Research on Complex Generics cosponsored a live virtual workshop titled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence ...
Andrew Babiskin, Fang Wu, Youssef Mousa, Ming‐Liang Tan, Eleftheria Tsakalozou, Ross L. Walenga, Miyoung Yoon, Sam G. Raney, James E. Polli, Anna Schwendeman, Vishalakshi Krishnan, Lanyan Fang, Liang Zhao   +12 more
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Generic drugs

Journal of the Indian Medical Association, 2008
Sometimes it seems as though generic drugs are one of those things that everybody likes as an idea, but they wouldn’t want to take one themselves. Ireland is at the bottom of the European market by value, and second from bottom by volume. Exports of generics make up a significant proportion of total finished product pharmaceutical exports.
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Analysis of Non-Pivotal Bioequivalence Studies Submitted in Abbreviated New Drug Submissions for Delayed-Release Drug Products

Journal of Pharmacy & Pharmaceutical Sciences, 2017
The US FDA’s rule on “Requirements for Submission of Bioequivalence Data” requiring submission of all bioequivalence (BE) studies conducted on the same formulation of the drug product submitted for approval was published in Federal Register in January ...
Paramjeet Kaur, Xiaojian Jiang, Ethan Stier   +2 more
doaj   +1 more source

The Future of Generic Biologics: Should the United States “Follow-On” the European Pathway? [PDF]

, 2008
The United States is embarking on a biotechnology drug revolution. In the last few decades, biotech drugs have saved millions of lives, and the market for these miracle cures continues to grow at an astronomical rate.
Kaldre, Ingrid
core   +4 more sources

Virtual screening FDA approved drugs against multiple targets of SARS‐CoV‐2

Clinical and Translational Science, 2021
The outbreak of the novel coronavirus severe acute respiratory syndrome‐coronavirus 2 (SARS‐CoV‐2), the causative agent of coronavirus disease 2019 (COVID‐19) respiratory disease, led to a global pandemic with high morbidity and mortality.
Hualou Liang, Liang Zhao, Xiajing Gong, Meng Hu, Hongbin Wang   +4 more
doaj   +1 more source

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop

CPT: Pharmacometrics & Systems Pharmacology, 2023
On November 30, 2021, the US Food and Drug administration (FDA) and the Center for Research on Complex Generics (CRCG) hosted a virtual public workshop titled “Establishing the Suitability of Model‐Integrated Evidence (MIE) to Demonstrate Bioequivalence ...
Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao   +17 more
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Pharmacological activities and effective substances of the component-based Chinese medicine of Ginkgo biloba leaves based on serum pharmacochemistry, metabonomics and network pharmacology

Frontiers in Pharmacology, 2023
As a potential drug candidate for the treatment of hypertension and complications, it is speculated that the component-based Chinese medicine of Ginkgo biloba leaves (GBCCM) which mainly composed of flavonoid aglycones (FAs) and terpene lactones (TLs ...
Hongbao Liang, Hongbao Liang, Hongbao Liang, Jingchun Yao, Jingchun Yao, Yu Miao, Yu Miao, Ying Sun, Ying Sun, Ying Sun, Yanbing Gao, Chenghong Sun, Chenghong Sun, Rui Li, Rui Li, He Xiao, He Xiao, Qun Feng, Qun Feng, Guofei Qin, Guofei Qin, Xiaoyan Lu, Xiaoyan Lu, Zhong Liu, Zhong Liu, Guimin Zhang, Guimin Zhang, Feng Li, Mingguo Shao   +28 more
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Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis Under the Sherman Act and the Noerr-Pennington Doctrine [PDF]

, 2017
The Hatch-Waxman Act of 1984 regulates approval by the Food and Drug Administration (“FDA”) of generic counterparts to patented drugs. In a series of recent cases, large pharmaceutical companies have been accused of exploiting Hatch-Waxman in violation ...
Resek, John F., Ph.D.
core   +2 more sources