Search results for " classification system"
showing 10 items of 42 documents
Segmental-dependent permeability throughout the small intestine following oral drug administration: Single-pass vs. Doluisio approach to in-situ rat …
2016
Abstract Intestinal drug permeability is position dependent and pertains to a specific point along the intestinal membrane, and the resulted segmental-dependent permeability phenomenon has been recognized as a critical factor in the overall absorption of drug following oral administration. The aim of this research was to compare segmental-dependent permeability data obtained from two different rat intestinal perfusion approaches: the single-pass intestinal perfusion (SPIP) model and the closed-loop (Doluisio) rat perfusion method. The rat intestinal permeability of 12 model drugs with different permeability characteristics (low, moderate, and high, as well as passively and actively absorbed…
Volume of Neonatal Care and Survival without Disability at 2 Years in Very Preterm Infants: Results of a French National Cohort Study
2019
International audience; Objectives To investigate the relation between neonatal intensive care unit (NICU) volume and survival, and neuromotor and sensory disabilities at 2 years in very preterm infants. Study design The EPIPAGE-2 (Etude Epidémiologique sur les Petits Âges Gestationnels-2) national prospective population-based cohort study was used to include 2447 babies born alive in 66 level III hospitals between 24 and 30 completed weeks of gestation in 2011. The outcome was survival without disabilities (levels 2-5 of the Gross Motor Function Classification System for cerebral palsy with or without unilateral or bilateral blindness or deafness). Units were grouped in quartiles according…
Clinical behavior of children with infantile cerebral palsy after ozone therapy
2018
Objective.
 The aim of this study was to determine the usefulness of ozone therapy in the treatment of Infantile Cerebral Palsy (ICP). 
 
 Patients and methods.
 A non-controlled clinical assay was made in the Ozone Research Center (CIO), Havana, Cuba from January 2013 to January 2014. The sample was constituted by patients remitted to pediatrics consultation of CIO, to whom inclusion and exclusion criteria were applied. The study group involved 45 patients, from 1 month of birth to 8 years, with cerebral palsy of hypoxic-ischemic cause. The evaluation criteria were: evolution of the motor disorder according to the Gross Motor Function Classification System (GMFCS) scale…
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Ondansetron.
2019
Literature data pertaining to the physicochemical, pharmaceutical, and pharmacokinetic properties of ondansetron hydrochloride dihydrate are reviewed to arrive at a decision on whether a marketing authorization of an immediate release (IR) solid oral dosage form can be approved based on a Biopharmaceutics Classification System (BCS)-based biowaiver. Ondansetron, a 5HT3 receptor antagonist, is used at doses ranging from 4 mg to 24 mg in the management of nausea and vomiting associated with chemotherapy, radiotherapy, and postoperative treatment. It is a weak base and thus exhibits pH-dependent solubility. However, it is able to meet the criteria of "high solubility" as well as "high permeabi…
Biowaiver Monographs for Immediate-Release Solid Oral Dosage Forms: Folic Acid.
2018
This work presents a review of literature and experimental data relevant to the possibility of waiving pharmacokinetic bioequivalence studies in human volunteers for approval of immediate-release solid oral pharmaceutical forms containing folic acid as the single active pharmaceutical ingredient. For dosage forms containing 5 mg folic acid, the highest dose strength on the World Health Organization Essential Medicines List, the dose/solubility ratio calculated from solubility studies was higher than 250 mL, corresponding to a classification as "not highly soluble." Small, physiological doses of folic acid (≤320 μg) seem to be absorbed completely via active transport, but permeability data f…
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.
Formulation predictive dissolution (fPD) testing to advance oral drug product development: an introduction to the US FDA funded ‘21st Century BA/BE’ …
2018
Over the past decade, formulation predictive dissolution (fPD) testing has gained increasing attention. Another mindset is pushed forward where scientists in our field are more confident to explore the in vivo behavior of an oral drug product by performing predictive in vitro dissolution studies. Similarly, there is an increasing interest in the application of modern computational fluid dynamics (CFD) frameworks and high-performance computing platforms to study the local processes underlying absorption within the gastrointestinal (GI) tract. In that way, CFD and computing platforms both can inform future PBPK-based in silico frameworks and determine the GI-motility-driven hydrodynamic impac…
Influence of environmental factors on the spatial distribution and diversity of forest soil in Latvia
2012
This study was carried out to determine the spatial relationships between environmental factors (Quaternary deposits, topographical situation, land cover, forest site types, tree species, soil texture) and soil groups, and their prefix qualifiers (according to the international Food and Agricultural Organization soil classification system World Reference Base for Soil Resources [FAO WRB]). The results show that it is possible to establish relationships between the distribution of environmental factors and soil groups by applying the generalized linear models in data statistical analysis, using the R 2.11.1 software for processing data from 113 sampling plots throughout the forest terri…
Do Firms Share the Same Functional Form of Their Growth Rate Distribution? A New Statistical Test
2011
We propose a hypothesis testing procedure to investigate whether the same growth rate distribution is shared by all the firms in a balanced panel or, more generally, whether they share the same functional form for this distribution, without necessarily sharing the same parameters. We apply the test to panels of US and European Union publicly quoted manufacturing firms, both at the sectoral and at the subsectoral NAICS levels. We consider the following null hypotheses about the growth rate distribution of the individual firms: i) an unknown shape common to all firms, with all the firms sharing also the same parameters, or with the firm variance related to its firm size through a scaling rela…
INSTITUTIONAL FRAMEWORK OF THE SEUROP CLASSIFICATION SYSTEM IN ROMANIA
2015
The aim of this paper is to present the institutional framework developed by Romania in the process to implement the European Union legislation in the field of animal classification. It describes the organizations involved in the system, outlining their responsibilities related to various aspects of the sector. The results of the research are useful for other European Union candidate countries in their integration effort.