Results 51 to 60 of about 244,106 (290)

Prediction of human drug clearance and anticipation of clinical drug-drug interaction potential from in vitro drug transport studies [PDF]

, 2014
A major concern in drug development is the characterization of new molecular entities (NMEs) with respect to their safety and efficacy. Both factors are determined by the drug’s exposure within the body which itself is affected by drug clearance ...
Kunze, Annett
core   +1 more source

Septin 9 PB domains coordinate centrosome positioning and microtubule acetylation to control epithelial polarity

FEBS Letters, EarlyView.
Septin 9 polybasic domains couple phosphoinositide‐rich membrane binding to centrosome positioning, Golgi organization, and microtubule acetylation to control epithelial polarity. Their loss disrupts this axis, causing centrosome mispositioning, Golgi fragmentation, reduced microtubule acetylation, and polarity inversion via upregulation of the ...
Ting ting Cai, Mohyeddine Omrane, Nassima Benzoubir, Didier Samuel, Ama Gassama‐Diagne   +4 more
wiley   +1 more source

Important missing information in Japan's risk management plans: a cross-sectional analysis after a decade of implementation

Frontiers in Medicine
IntroductionMore than 10 years have passed since Japan introduced risk management plans (RMPs), yet research focusing on important missing information (IMI) remains limited.
Natsuko Kameyama, Natsuko Kameyama, Ayana Ide, Hideki Maeda, Hideki Maeda   +4 more
doaj   +1 more source

Packaging and Labeling of Pharmaceutical Products Obtained from the Internet

Journal of Medical Internet Research, 2011
BackgroundFor patients, the prescription container label may be the only source of instructions on how to take their medicines. In the United States, the legal requirements for a prescription label are set by federal law and state statutes. The container
Veronin, Michael
doaj   +1 more source

Patient-reported outcomes labeling for oncology drugs: Multidisciplinary perspectives on current status and future directions

Frontiers in Pharmacology, 2022
Introduction: Regulatory agencies encourage the incorporation of the patient voices throughout clinical drug development. Patient-Reported Outcomes (PROs) offer one way of doing this and their use has markedly increased in many therapeutic areas ...
David Cella, Chieh-I Chen, Ruben G. W. Quek, Ainhoa Uribarren, Matthew Reaney, Vera Mastey, Deborah Collyar, Olivier Chassany, Olivier Chassany   +8 more
doaj   +1 more source

Degradation mechanism of the von Willebrand factor A2 domain by nattokinase

FEBS Letters, EarlyView.
Nattokinase, a natto‐derived protease, exhibits potent antithrombotic effects. This study demonstrates that nattokinase directly cleaves the von Willebrand factor (vWF) A2 domain in vitro. Unlike the native regulator ADAMTS13, nattokinase degrades folded vWF independently of shear stress.
Ryuichi Hyakumoto, Masatomo So, Ayako Furukawa, Kenji Sugase   +3 more
wiley   +1 more source

Recent developments in heterocycle labeling with carbon isotopes [PDF]

, 2018
International audienceHeterocycles play an essential role in modern pharmaceutical and agrochemical developments, representing a very common structural unit in marketed drugs.
Taran, Frédéric, Destro, Gianluca, Davide Audisio, Del Vecchio, Antonio, Antonio Del Vecchio, Audisio, Davide, Frédéric Taran, Gianluca Destro   +7 more
core   +2 more sources

Communication of Survival Data in US Food and Drug Administration–Approved Labeling of Cancer Drugs [PDF]

, 2021
This cross-sectional study examines how information on overall survival benefits of novel cancer drug indications is communicated in ...
Naci, Huseyin, Wagner, Anita K., Woloshin, Steven, Xu, Ziyue, Guan, Xiaodong   +4 more
core   +1 more source

ADME Gene-Related Pharmacogenomic Labeling of FDA-Approved Drugs: Comparison with Clinical Pharmacogenetics Implementation Consortium (CPIC) Evidence Levels

Medicines
Pharmacogenomics (PGx) can facilitate the transition to patient-specific drug regimens and thus improve their efficacy and reduce toxicity. The aim of this study was to evaluate the overlap of PGx classification for drug absorption, distribution ...
Subrata Deb, Robert Hopefl, Anthony Allen Reeves, Dena Cvetkovic   +3 more
doaj   +1 more source

Level of Evidence Associated with FDA Safety Communications with Drug Labeling Changes: 2010-2014

INNOVATIONS in Pharmacy, 2017
Purpose: Approximately 800,000 safety reports are submitted to the FDA annually, however, only significant issues generate drug safety communications (DSC). The purpose of this study was to determine the type of clinical evidence used to warrant a change
Benjamin Hixon, Joseph M. Lowrey, Lindsay N Hume, Katelynn Mayberry, Maisha Kelly Freeman   +4 more
doaj   +1 more source