Results 41 to 50 of about 351,529 (205)

Use of physiologically‐based pharmacokinetic modeling to understand the effect of omeprazole administration on the pharmacokinetics of oral extended‐release nifedipine

CPT: Pharmacometrics & Systems Pharmacology
Proton pump inhibitors (PPIs) can affect the release of drugs from their dosage forms in vivo by elevating the gastric pH. Our recent clinical study has demonstrated that drug–drug interactions (DDIs) exist between a PPI, omeprazole, and nifedipine ...
Ming‐Liang Tan, Zongming Gao, Andrew Babiskin, Myong‐Jin Kim, Lanyan Fang, Lei Zhang, Liang Zhao   +6 more
doaj   +1 more source

A nano-preparation approach to enable the delivery of daphnoretin to potentiate the therapeutical efficacy in hepatocellular cancer

Frontiers in Pharmacology, 2022
Daphnoretin (DAP), isolated from a traditional Chinese medicine Wikstroemia indica (Linn. C. A. Meyer), could induce apoptosis of hepatocellular cancer (HCC) and inhibit tumor growth.
Guanglin Zhu, Bing Wang, Guo Feng, Zhirong Zhou, Wei Li, Wen Liu, Hongmei Su, Wenjing Wang, Tiejie Wang, Xie-an Yu   +9 more
doaj   +1 more source

In Silico Methods for Development of Generic Drug–Device Combination Orally Inhaled Drug Products

CPT: Pharmacometrics & Systems Pharmacology, 2019
The development of generic, single‐entity, drug–device combination products for orally inhaled drug products is challenging in part because of the complex nature of device design characteristics and the difficulties associated with establishing ...
Ross L. Walenga, Andrew H. Babiskin, Liang Zhao   +2 more
doaj   +1 more source

Evaluation of model‐based bioequivalence approach for single sample pharmacokinetic studies

CPT: Pharmacometrics & Systems Pharmacology, 2023
In a traditional pharmacokinetic (PK) bioequivalence (BE) study, a two‐way crossover study is conducted, PK parameters (namely the area under the time‐concentration curve [AUC] and the maximal concentration [Cmax]) are obtained by noncompartmental ...
Coralie Tardivon, Florence Loingeville, Mark Donnelly, Kairui Feng, Wanjie Sun, Guoying Sun, Stella Grosser, Liang Zhao, Lanyan Fang, France Mentré, Julie Bertrand   +10 more
doaj   +1 more source

Osteoporosis: New-Generation Drugs [PDF]

Breast Care, 2010
A new understanding in the pathophysiology of bone led to the development of a fully human monoclonal antibody directed against RANK ligand (RANKL). Denosumab inhibits the interaction of RANKL with its receptor RANK, thereby suppressing osteoclast differentiation, function and survival.
openaire   +2 more sources

Hatch–Waxman Reform and Accelerated Market Entry of Generic Drugs: Is Faster Necessarily Better? [PDF]

, 2003
Recently there has been a considerable amount of pressure to accelerate consumer access to generic drugs, which are significantly less expensive than their brand-name counterparts.
Eurek, Sarah E.
core   +1 more source

Impact of Mechanistic Modeling and Simulation Methodologies on Product‐Specific Guidance Development for Non‐Orally Administered Drug Products

CPT: Pharmacometrics & Systems Pharmacology
The U.S. Food and Drug Administration (FDA) publishes product‐specific guidances (PSGs), with bioequivalence (BE) recommendations for prospective generics.
Steven G. Chopski, Ross L. Walenga, Ming‐Liang Tan, Khondoker Alam, Andrew Babiskin, Lanyan Fang, Eleftheria Tsakalozou   +6 more
doaj   +1 more source

Visible-light Promoted Atom Transfer Radical Addition−Elimination (ATRE) Reaction for the Synthesis of Fluoroalkylated Alkenes Using DMA as Electron-donor

Molecules, 2020
Here, we describe a mild, catalyst-free and operationally-simple strategy for the direct fluoroalkylation of olefins driven by the photochemical activity of an electron donor−acceptor (EDA) complex between DMA and fluoroalkyl iodides.
Wen-Wen Xu, Le Wang, Ting Mao, Jiwei Gu, Xiao-Fei Li, Chun-Yang He   +5 more
doaj   +1 more source

\u3ci\u3eMutual Pharmaceutical Co. v. Bartlett\u3c/i\u3e and Its Implications [PDF]

, 2013
The authors state that the U.S. Supreme Court’s preemption ruling in Mutual Pharmaceutical Co. v. Bartlett, which generally shields generic drug manufacturers from state-law damages liability for design-defect claims, may also have broader implications ...
King, Anne, Wolfman, Brian
core   +1 more source

Regulatory utility of physiologically‐based pharmacokinetic modeling to support alternative bioequivalence approaches and risk assessment: A workshop summary report

CPT: Pharmacometrics & Systems Pharmacology, 2023
This report summarizes the proceedings for day 2 sessions 1 and 3 of the 2‐day public workshop entitled “Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches,” a jointly sponsored workshop by the US Food and Drug ...
Fang Wu, Youssef Mousa, Kimberly Raines, Chris Bode, Yu Chung Tsang, Rodrigo Cristofoletti, Hongling Zhang, Tycho Heimbach, Lanyan Fang, Filippos Kesisoglou, Amitava Mitra, James Polli, Myong‐Jin Kim, Jianghong Fan, Banu S. Zolnik, Duxin Sun, Yi Zhang, Liang Zhao   +17 more
doaj   +1 more source