Results 61 to 70 of about 280,132 (308)

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

open access: yesCPT: 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   +6 more
doaj   +1 more source

Delayed Access to Generic Medicine: A Comment on the Hatch-Waxman Act and the Approval Bottleneck [PDF]

open access: yes, 2009
Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts, can save consumers billions of dollars per year. The Hatch-Waxman Act, which governs the introduction
Patel, Ankur N.
core   +1 more source

High Humidity Exacerbates Psoriasiform Skin Disease Relapse by Increasing Tissue‐Resident Memory T Cells via Altering Skin Microbiota

open access: yesAdvanced Science, EarlyView.
We demonstrated that high humidity worsened psoriasis relapse in murine psoriasiform skin inflammation by increasing skin‐resident memory CD8+ cells via upregulating IL‐15Rα on keratinocytes. The increases in IL‐15Rα and memory CD8+ cells were attributed to S. nepalensis and its metabolite ADMA in skin exposed to high humidity.
Chun‐Ling Liang   +10 more
wiley   +1 more source

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

open access: yesCPT: 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   +6 more
doaj   +1 more source

Marburg Virus Glycoprotein Is a Remarkable Virulent Factor Linked to Hemorrhagic Pathology: Evidence from Multimodal Experimental Systems

open access: yesAdvanced Science, EarlyView.
By integrating data from in vitro, ex vivo, and in vivo models, our research identifies the MARV glycoprotein as a remarkable hemorrhagic factor, filling a major gap in this important field. It also provides practical experimental tools for the basic research on viral pathogenesis and applied research aimed at antiviral intervention for hemorrhagic ...
Ting Yao   +11 more
wiley   +1 more source

Predictive Analysis for First Submission of Generic Drug Application for Orphan Drug Products Using Random Survival Forest

open access: yesClinical and Translational Science
Rare diseases affect a small population of patients, resulting in low incentives for developing orphan drug products (ODPs). The United States Congress passed the Orphan Drug Act of 1983 to incentivize pharmaceutical manufacturers to develop drugs to ...
Robert Hopefl   +6 more
doaj   +1 more source

Uncertainty in the Generic Versus Brand Name Prescription Decision [PDF]

open access: yes
This paper analyzes the impact of uncertainty concerning product quality of generic drugs on the substitution behavior of prescribing physicians. It is shown that uncertainty about the generic drug quality gives the physician a value of waiting for more ...
Hellström, Jörgen, Rudholm, Niklas
core   +1 more source

The implications of WTO accession on the pharmaceutical industry in China [PDF]

open access: yes, 2002
Given the limited capabilities of R&D and global distribution channels, and the virtual non-existence of patented drugs, the Chinese pharmaceutical industry has little chance to enter the global market of Western prescription drugs and compete with the ...
Yeung, Godfrey
core   +1 more source

Engineering Osteoimmune Responses with Functionalized Orthopedic Implants for Post‐Operative Osteosarcoma Treatment

open access: yesAdvanced Science, EarlyView.
Osteosarcoma is the most common primary bone tumor with limited treatment options and a terrible prognosis. This review provides a comprehensive summary of the recent development of osteoimmunomodulatory implants for post‐operative osteosarcoma treatment, of which the potential utility in evoking durable anti‐osteosarcoma immunity and accelerating bone
Yilong Dong   +6 more
wiley   +1 more source

Mass Spectrometry Imaging‐Assisted Discovery of Gallotannin Biosynthetic Genes in the Root of Paeonia suffruticosa

open access: yesAdvanced Science, EarlyView.
An integrated approach combining mass spectrometry imaging, transcriptomics, and phylogenetic analysis facilitated the efficient identification of genes involved in gallotannin biosynthesis in Paeonia suffruticosa. As a result, a key UGT and several SCPL acyltransferases responsible for biosynthesizing pentagalloylglucose were successfully identified ...
Yushi Liu   +4 more
wiley   +1 more source

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