Search results for "Product characteristics"
showing 10 items of 12 documents
The impact of the EMA change in definition of "dose" on the BCS dose-solubility ratio: a review of the biowaiver monographs.
2013
The Biopharmaceutics Classification System (BCS) defines the solubility characteristics of an active pharmaceutical substance based on its dose-solubility ratio: for highly soluble drugs this ratio is less than 250 mL over a defined pH range. Prior to the revision of the European Medicines Agency (EMA, formerly EMEA) guideline in 2010, the "dose" in this ratio was consistently defined by the US FDA, the EMA, and the WHO biowaiver guidelines as the highest dosage strength. However, in the revised EMA guideline, the dose is defined as the highest single dose administered according to the Summary of Product Characteristics. The new EMA criterion for highly soluble may be closer to the actual c…
Italian Health Care Workers’ Knowledge, Attitudes, and Practices Regarding Human Papillomavirus Infection and Prevention
2020
Objective: To assess healthcare workers&rsquo
THE SURVIVAL OF DIFFERENTIATED PRODUCTS: AN APPLICATION TO THE UK AUTOMOBILE MARKET, 1971-2002*
2009
We investigate how competition affected the survival of products in the UK automobile market between 1971 and 2002. We find, after using a host of controls to account for product characteristics and changes in market structure, that (i) within and between firm spatial competition significantly reduces the life of a model, (ii) initial product differentiation and variant proliferation obviate competition, and (iii) product innovation significantly extends model survival.
Interaction risk with proton pump inhibitors in general practice: significant disagreement between different drug-related information sources.
2006
Aims To compare information on drug–drug interactions (DDIs) reported on two standard drug-related information sources (Summary of Product Characteristics and Drugdex system by Micromedex), by assessing the prevalence and predictors of potential DDI with proton pump inhibitors (PPIs) in general practice. Methods From the ‘Caserta-1’ Local Health-Service database, 156 general practitioners (GPs) were recruited. From more than 180 000 individuals registered on their lists, we selected patients receiving co-prescription of PPI and medications at interaction risk, according to the Italian Summary of Product Characteristics (SPC) of PPI and Drugdex information, during the year 2003. Thereafter, …
Calculating Hedonic Price Indices with Unobserved Product Attributes: An Application to the UK Car Market
2006
We show that hedonic price indices that omit model-specific unobservable product attributes are subject to considerable bias. We utilize a complete panel of new car versions marketed in the UK over 1971–98 which incorporates over 100 observable product characteristics, sales weighting to capture the distribution of purchases across models, and model-specific fixed effects to account for unobservable characteristics. We find that quality-adjusted prices obtained from hedonic regressions that do not account for unobservable characteristics exhibit a severe downward bias. We also show that quality-adjusted prices exhibit distinct sub-market differences having increased in ‘mass production’ seg…
How Have Intravitreal Anti-VEGF and Dexamethasone Implant Been Used in Italy? A Multiregional, Population-Based Study in the Years 2010–2016
2020
Purpose. To describe intravitreal anti-VEGF drug and dexamethasone use in four Italian regions. Methods. Four regional claims databases were used to measure drug prevalence, compare dosing intervals to those recommended in the summary of product characteristics (SPC), and identify switchers. Bilateral treatment and diabetic macular edema (DME) coding algorithms were validated, linking claims with a sample of prospectively collected ophthalmological data. Results. Overall, 41,836 patients received ≥1 study drug in 2010–2016 (4.8 per 10,000 persons). In 2016, anti-VEGF drug use ranged from 0.8 (Basilicata) to 5.7 (Lombardy) per 10,000 persons while intravitreal dexamethasone use ranged from 0…
Corporate entrepreneurship and human resource management: theoretical background and a case study
2011
Purpose: This article aims to review varying concepts of entrepreneurship and different contributions to human resource practices, establishing a theoretical framework that allows for the analysis of the firm Montalt-Valencia (Spain), a Ford-Spain car dealer, and leader in its sector. Design/methodology/approach: The paper, according to the literature, establishes a theoretical framework on entrepreneurship and human resource management through which one can observe and research the Montalt-Valencia case study. The case study is confirmatory, from the theoretical background, and at the same time inductive from the observation of its non-expected details and deeds. Findings: The firm Montalt…
French summaries of product characteristics: content in relation to therapeutic monitoring of psychotropic drugs
2010
The prescription information (summary of product characteristics, SPC) is compiled by the pharmaceutical industry as required by the national regulatory authorities. They vary in their content about the properties of drugs and about the usefulness of therapeutic drug monitoring (TDM) in the blood of patients. Based on a previous study carried out in Germany, the degree of agreement of French SPC for 59 psychotropic drugs with the existing medico-scientific evidence in the area of TDM was examined using a recently developed instrument. A summary score of SPC content (SPCC) related to TDM (SPCC TDM ) has been calculated and compared with the level of recommendation of TDM of the AGNP-TDM expe…
Vitamins in wine: Which, what for, and how much?
2021
Vitamins are essential compounds to yeasts, and notably in winemaking contexts. Vitamins are involved in numerous yeast metabolic pathways, including those of amino acids, fatty acids, and alcohols, which suggests their notable implication in fermentation courses, as well as in the development of aromatic compounds in wines. Although they are major components in the course of those microbial processes, their significance and impact have not been extensively studied in the context of winemaking and wine products, as most of the studies focusing on the subject in the past decades have relied on relatively insensitive and imprecise analytical methods. Therefore, this review provides an extensi…
Clinical management of drug-drug interactions in HCV therapy: Challenges and solutions.
2013
Contains fulltext : 118153.pdf (Publisher’s version ) (Open Access) Hepatitis C virus (HCV) infected patients often take multiple co-medications to treat adverse events related to HCV therapy, or to manage other co-morbidities. Drug-drug interactions associated with this polypharmacy are relatively new to the field of HCV pharmacotherapy. With the advent of the direct-acting antivirals telaprevir and boceprevir, which are both substrates and inhibitors of the cytochrome P450 (CYP) 3A iso-enzyme, knowledge and awareness of drug-drug interactions have become a cornerstone in the evaluation of patients starting and continuing HCV combination therapy. In our opinion, an overview of conducted dr…