Results 31 to 40 of about 4,282,960 (349)

Effect of the Similarity of Formulations and Excipients of Approved Generic Drug Products on In Vivo Bioequivalence for Putative Biopharmaceutics Classification System Class III Drugs

Pharmaceutics, 2023
One of the potential essential factors that restricts generic industry from applying the Biopharmaceutics Classification System (BCS) Class III biowaiver is adherence to the stringent formulation criteria for formulation qualitative (Q1) sameness and ...
Ping Ren, Theresa Chan, Wen-Cheng Yang, Mitchell Frost, Yan Wang, Markham Luke, Myong-Jin Kim, Robert Lionberger, Yi Zhang   +8 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
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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
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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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Physiologically‐based pharmacokinetic modeling to support bioequivalence and approval of generic products: A case for diclofenac sodium topical gel, 1%

CPT: Pharmacometrics & Systems Pharmacology, 2021
Establishing bioequivalence (BE) for dermatological drug products by conducting comparative clinical end point studies can be costly and the studies may not be sufficiently sensitive to detect certain formulation differences.
Eleftheria Tsakalozou, Andrew Babiskin, Liang Zhao   +2 more
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Generic Drugs in the United States: Policies to Address Pricing and Competition

Clinical pharmacology and therapy, 2019
The cost of prescription drugs in the United States continues to be a source of concern for patients, caregivers, and policymakers. Drug prices typically decline rapidly once generic drugs receive US Food and Drug Administration (FDA) approval and enter ...
Ravi Gupta, N. Shah, J. Ross
semanticscholar   +1 more source

Mechanistic modeling of generic orally inhaled drug products: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
In silico mechanistic modeling approaches have been designed by various stakeholders with the goal of supporting development and approval of generic orally inhaled drug products in the United States.
Ross L. Walenga, Clare Butler, Brent A. Craven, P. Worth Longest, Raja Mohamed, Bryan Newman, Bo Olsson, Günther Hochhaus, Bing V. Li, Markham C. Luke, Liang Zhao, Andrzej Przekwas, Robert Lionberger   +12 more
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Multi‐phase multi‐layer mechanistic dermal absorption (MPML MechDermA) model to predict local and systemic exposure of drug products applied on skin

CPT: Pharmacometrics & Systems Pharmacology, 2022
Physiologically‐based pharmacokinetic models combine knowledge about physiology, drug product properties, such as physicochemical parameters, absorption, distribution, metabolism, excretion characteristics, formulation attributes, and trial design or ...
Nikunjkumar Patel, James F. Clarke, Farzaneh Salem, Tariq Abdulla, Frederico Martins, Sumit Arora, Eleftheria Tsakalozou, Arran Hodgkinson, Omid Arjmandi‐Tash, Sinziana Cristea, Priyanka Ghosh, Khondoker Alam, Sam G. Raney, Masoud Jamei, Sebastian Polak   +14 more
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Amphotericin B release rate is the link between drug status in the liposomal bilayer and toxicity

Asian Journal of Pharmaceutical Sciences, 2022
Amphotericin B (AmB) is an amphiphilic drug commonly formulated in liposomes and administered intravenously to treat systemic fungal infections. Recent studies on the liposomal drug product have shed light on the AmB aggregation status in the bilayer ...
Yuri Svirkin, Jaeweon Lee, Richard Marx, Seongkyu Yoon, Nelson Landrau, Md Abul Kaisar, Bin Qin, Jin H. Park, Khondoker Alam, Darby Kozak, Yan Wang, Xiaoming Xu, Jiwen Zheng, Benjamin Rivnay   +13 more
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