Results 51 to 60 of about 280,718 (307)
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 +17 more
doaj +1 more source
Advanced Science, EarlyView.Nuclear metabolism oscillates during cell cycle progression. Quantitative chromatome proteomics and imaging reveal phase‐specific dynamics of PIP5K1A and nuclear PIP2, linking phosphatidylinositol metabolism to histone methylation. This work identifies nuclear lipid metabolism as a previously unrecognized regulatory axis coordinating chromatin ...
Antoni Gañez‐Zapater +13 more
wiley +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 +10 more
doaj +1 more source
Generic drugs: benefit/risk ratio
Неврология, нейропсихиатрия, психосоматика, 2021 The review discusses the interchangeability of medications, approaches to the registration of original and generic drugs, and types of their equivalence, as well as problems with generics in clinical practice.
E. A. Ushkalova +2 more
doaj +1 more source
The implications of WTO accession on the pharmaceutical industry in China [PDF]
, 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
Advanced 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
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
Advanced Science, EarlyView.ABSTRACT Acute pancreatitis (AP) begins with pancreatic local inflammation, leading to the onset of systemic inflammatory response syndrome (SIRS), followed by compensatory anti‐inflammatory response syndrome (CARS), which causes immune paralysis and higher mortality rate.
Liwei Liu +15 more
wiley +1 more source
A survey of Top 200 Drugs—Inconsistent Practice of Drug Strength Expression for Drugs Containing Salt Forms [PDF]
, 2012 Many ionizable drugs are developed and marketed as salt forms. However, there are no clear US regulatory guidelines on drug strength labeling for salts. The strengths of some drugs are expressed as salts and some as free acids/bases.
Prohotsky, Daniel, Zhao, Fang
core +2 more sources
Advanced 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