Search results for "Equivalence"
showing 10 items of 301 documents
Common fixed points of g-quasicontractions and related mappings in 0-complete partial metric spaces
2012
Abstract Common fixed point results are obtained in 0-complete partial metric spaces under various contractive conditions, including g-quasicontractions and mappings with a contractive iterate. In this way, several results obtained recently are generalized. Examples are provided when these results can be applied and neither corresponding metric results nor the results with the standard completeness assumption of the underlying partial metric space can. MSC:47H10, 54H25.
Precision, Applicability, and Economic Implications: A Comparison of Alternative Biodiversity Offset Indexes
2021
AbstractThe rates of ecosystem degradation and biodiversity loss are alarming and current conservation efforts are not sufficient to stop them. The need for new tools is urgent. One approach is biodiversity offsetting: a developer causing habitat degradation provides an improvement in biodiversity so that the lost ecological value is compensated for. Accurate and ecologically meaningful measurement of losses and estimation of gains are essential in reaching the no net loss goal or any other desired outcome of biodiversity offsetting. The chosen calculation method strongly influences biodiversity outcomes. We compare a multiplicative method, which is based on a habitat condition index develo…
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Amoxicillin Trihydrate
2018
Literature and experimental data relevant to waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release solid oral dosage forms containing amoxicillin trihydrate are reviewed. Solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), therapeutic uses, therapeutic index, excipient interactions, as well as dissolution and BE and bioavailability studies were taken into consideration. Solubility and permeability studies indicate that amoxicillin doses up to 875 mg belong to BCS class I, whereas 1000 mg belongs to BCS class II and doses of more than 1000 mg belong to BCS class IV. Considering all aspects, the biowaiver pro…
Biowaiver Monographs for Immediate Release Solid Oral Dosage Forms: Ribavirin
2015
Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release solid oral dosage forms containing ribavirin are reviewed. Ribavirin is highly soluble, but its permeability characteristics are not well defined. Therefore according to the Biopharmaceutical Classification System, and taking a “worst case” approach, ribavirin should be assigned to class III. As ribavirin is transported across the brush border membrane of the human jejunum by hCNT2, it shows saturable uptake in the intestine. However, no common excipients have been shown to compete for ribavirin absorption, nor have problems with BE of immediate release rib…
Bioequivalence decision for nanoparticular iron complex drugs for parenteral administration based on their disposition
2017
Although parenteral iron products have been established to medicinal use decades before, their structure and pharmacokinetic properties are not fully characterized yet. With its' second reflection paper on intravenous iron-based nano-colloidal products (EMA/CHMP/SWP/620008/2012) the European Medicine Agency provided an extensive catalogue of methods for quality, non-clinical and pharmacokinetic studies for the comparison of nano-sized iron products to an originator (EMA, 2015). For iron distribution studies, the reflection paper assumed the use of rodents. In our tests, we used a turkey fetus model to investigate time dependent tissue concentrations in pharmacological and toxicological rele…
Sense Equivalence in plWordNet to Princeton WordNet Mapping
2019
Abstract Though the interest in use of wordnets for lexicography is (gradually) growing, no research has been conducted so far on equivalence between lexical units (or senses) in inter-linked wordnets. In this paper, we present and validate a procedure of sense-linking between plWordNet and Princeton WordNet. The proposed procedure employs a continuum of three equivalence types: strong, regular and weak, distinguished by a custom-designed set of formal, semantic and translational features. To validate the procedure, three independent samples of 120 sense pairs were manually analysed with respect to the features. The results show that synsets from the two wordnets linked by interlingual syno…
Cross-cultural measurement invariance of the General Health Questionnaire-12 in a German and a Colombian population sample
2017
While the General Health Questionnaire, 12-item version (GHQ-12) has been widely used in cross-cultural comparisons, rigorous tests of the measurement equivalence of different language versions are still lacking. Thus, our study aims at investigating configural, metric and scalar invariance across the German and the Spanish version of the GHQ-12 in two population samples. The GHQ-12 was applied in two large-scale population-based samples in Germany (N = 1,977) and Colombia (N = 1,500). To investigate measurement equivalence, confirmatory factor analyses were conducted in both samples. In the German sample mean GHQ-12 total scores were higher than in the Colombian sample. A one-factor model …
Assessment of proneness to distraction: English adaptation and validation of the Attention-Related Driving Errors Scale (ARDES) and cross-cultural eq…
2016
Abstract Prior research developed the Attention-Related Driving Errors Scale (ARDES), a 19-item questionnaire aimed at evaluating the drivers’ predisposition to attentional error, and also provided validity evidence of ARDES measures across two countries: Argentina and Spain. In the current work we adapt the Spanish version of the ARDES to the English language and the culture, traffic regulations and driving habits of the UK, and then provide new evidence of the cross-cultural equivalence of the scale. First, an improved forward and backward translation design was used to translate the Spanish ARDES into English. A committee-approach review process was also performed during the translation …
Embeddings of a family of Danielewski hypersurfaces and certain \C^+-actions on \C^3
2006
International audience; We consider the family of complex polynomials in \C[x,y,z] of the form x^2y-z^2-xq(x,z). Two such polynomials P_1 and P_2 are equivalent if there is an automorphism \varphi of \C[x,y,z] such that \varphi(P_1)=P_2. We give a complete classification of the equivalence classes of these polynomials in the algebraic and analytic category.
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…