Search results for " Generic"
showing 10 items of 19 documents
Efficacy and safety of topiramate in migraine prophylaxis: an open controlled randomized study comparing Sincronil and topamax formulations.
2013
AIM: Topiramate is a small molecule widely used for the treatment of epilepsy, migraine, bipolar disorders and alcoholism, and its availability as a generic formulation could significantly reduce the National Health Service expenditure. A generic formulation, available in Italy under the trademark Sincronil, recently showed superimposable blood levels, after oral administration to healthy volunteers, with the reference formulation. In the present study we report the results of an open label, parallel group, randomized, controlled study performed to evaluate the efficacy, tolerability and impact on disability of two different formulations of topiramate (Sincronil and Topamax) in patients wit…
Generic vancomycin products: Analysis of serum concentrations in patients with acute myeloid leukemia.
2013
Summary Concerns have recently emerged about the quality of generic vancomycin products. Our aim is to analyze serum vancomycin concentrations measured 48 hours after the start of an empirical treatment regimen in patients with acute myeloid leukemia (AML) who received one of the two generic vancomycin products available in France. Patients and methods Seventy-nine AML patients treated with vancomycin during two study periods were included in the study. Our vancomycin dosing regimen was based on the patients’ total body weight adjusted for renal clearance. Results A total of 93 serum vancomycin concentrations were collected: 31 in period 1 and 62 in period 2. In bivariate analysis, the mean…
Generic revision of Cypricercinae McKenzie, 1971 (Crustacea, Ostracoda), with the description of three new genera and one new species and a phylogene…
2009
The Cypricercinae are one of the most speciose subfamilies of non-marine ostracods, with more than 170 described species, mostly from the tropics. Although the identity of the subfamily as such is clear, because of the presence of unifying characters such as the Triebel’s loop in the attachment of the caudal ramus, the supra-specific taxonomy of this group has long been confused because of lack of good generic and tribal characters. Here, the generic characters of the Cypricercinae are revised. Eleven genera are retained in this subfamily, including three new genera: Bradleytriebella n. gen., Nealecypris n. gen. and Pseudostrandesia n. gen. Tanycypris siamensis n. sp. is described from Thai…
Rivestimenti di varietà algebriche contenuti in fibrati di piani proiettivi
Biosimilar and generic formulations of novel antidiabetic drugs: the role of liraglutide in clinical pharmacology of type 2 diabetes.
2022
Patterns and trends in scientific research on generic drugs
2016
[Purpose]: The purpose of this study to investigate the evolution and current status of peer-reviewed publications concerning generic drugs during the past few decades. [Methods]: Scientific articles about generic drugs published until 2012 were retrieved through the PubMed/MEDLINE database, and a content analysis was performed. [Findings]: Our study revealed an increasing number of publications on generics since 1984. Statins, antiretroviral therapies, and antiepileptics, followed by immunosuppressants and antithrombotic agents, were the most common therapeutic drug categories. [Implications]: Almost 60% of the generics detailed in studies indexed in MEDLINE were acting on the cardiovascul…
Differences in tissue distribution of iron from various clinically used intravenous iron complexes in fetal avian heart and liver.
2015
Abstract Nanomedicines are more complex than most pharmacologically active substances or medicines and have been considered as non-biological complex drugs. For nanomedicines pivotal pharmacokinetic properties cannot be assessed by plasma concentration data from standard bioequivalence studies. Using intravenous iron complexes (IICs) as model we show that fetal avian tissues can be used to study time dependent tissue concentrations in heart and liver. Clear differences were found between equimolar doses of sucrose, gluconate or carboxymaltose coated iron particles. The range in tissue iron concentrations observed with these clinically widely used IICs provides an orientation as to what shou…
Enhancing performance of α‐diiminonickel precatalyst for ethylene polymerization by substitution with the 2,4‐bis(4,4'‐dimethoxybenzhydryl)‐6‐methylp…
2020
High activities in ethylene polymerization predetermine α‐diiminonickel precatalysts for potential industrial applications. In our study, we have synthesized and characterized a series of unsymmetrical 1‐(2,4‐bis(4,4′‐dimethoxybenzhydryl)‐6‐MeC6H2N)‐2‐arylimino‐acenaphthylene nickel(II) halides. The single‐crystal X‐ray diffraction study of representative compounds reveals distorted tetrahedral geometry. On activation with either Me2AlCl or modified methylaluminoxane, these nickel complexes exhibit high activities of the order of 106 g of PE (mol of Ni)−1 h−1 and produce polyethylene of generic application characterized by high molecular weight, narrow molecular weight distribution, and mod…
Retrospective evaluation of persistence in osteoporosis therapy with oral bisphosphonates in Italy: the TOBI study
2019
The patients’ persistence with osteoporosis treatments is low. This retrospective, multicenter survey showed that almost 30% of osteoporotic patients discontinued the treatment within the first 6 months and that those taking drinkable bisphosphonates were less likely to interrupt the therapy; instead, the use of generic bisphosphonates was associated to a more precocious interruption. Purpose: Low persistence with osteoporosis medications is associated with higher fracture risk. This study aimed to assess the persistence to treatment with oral bisphosphonates among Italian osteoporotic patients under treatment for at least 6 months and to evaluate whether the different oral formulations of …
Bioequivalence of oral products and the biopharmaceutics classification system: science, regulation, and public policy.
2011
The demonstration of bioequivalence (BE) is an essential requirement for ensuring that patients receive a product that performs as indicated by the label. The BE standard for a particular product is set by its innovator, and this standard must subsequently be matched by generic drug products. The Biopharmaceutics Classification System (BCS) sets a scientific basis for an improved BE standard for immediate-release solid oral dosage forms. In this paper, we discuss BE and the BCS, as well as the issues that are currently relevant to BE as a pharmaceutical product standard.