Results 21 to 30 of about 1,550,569 (253)

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

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

Non-equivalence of antibiotic generic drugs and risk for intensive care patients [PDF]

, 2013
Background: The underlying axiom in applying generic drugs is the equivalence of their active ingredient with the (usually more expensive) innovator product, an all-embracing statement with the insidious result that physicians assume that the generic ...
Reshetnykov, Mykhaylo, Rangoonwala, Ramzan, Ghanaati, Shahram Michael, Kirkpatrick, Charles James, Barbeck, Mike   +4 more
core   +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

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

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
doaj   +1 more source

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
doaj   +1 more source

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