Search results for "equivalence"
showing 10 items of 301 documents
On Finite Satisfiability of Two-Variable First-Order Logic with Equivalence Relations
2009
We show that every finitely satisfiable two-variable first-order formula with two equivalence relations has a model of size at most triply exponential with respect to its length. Thus the finite satisfiability problem for two-variable logic over the class of structures with two equivalence relations is decidable in nondeterministic triply exponential time. We also show that replacing one of the equivalence relations in the considered class of structures by a relation which is only required to be transitive leads to undecidability. This sharpens the earlier result that two-variable logic is undecidable over the class of structures with two transitive relations.
Optimal shakedown design of beam structures
1994
The optimal design of plane beam structures made of elastic perfectly plastic material is studied according to the shakedown criterion. The design problem is formulated by means of a statical approach on the grounds of the shakedown lower bound theorem, and by means of a kinematical approach on the grounds of the shakedown upper bound theorem. In both cases two different types of design problems are formulated: one searches for the minimum volume design whose shakedown limit load is assigned; the other searches for the design of the assigned volume whose shakedown limit load is maximum. The optimality conditions of the four problems above are found by the use of a variational approach; such…
Testing invariance between web and paper students satisfaction surveys. A case study
2017
[EN] Purpose: This paper studied the measurement invariance (MI) across web-based and paper-based surveys to evidence if both techniques of data collection can be regarded as equivalent. Design/methodology: We develop a multigroup confirmatory factor analysis (MGCFA) with Maximum Likelihood Estimation to asses measurement invariance of the Job Diagnostic Survey (JDS) adapted to teaching, with data collected from paper and web surveys. Sample from paper surveys was constituted by 294 student of a Spanish public university in the academic years 2007-08, 2008-09 and 2009-10. Internet surveys were administered through an open source survey application called Lime Survey. We received 241 complet…
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…
In silicoprediction of drug dissolution and absorption with variation in intestinal pH for BCS class II weak acid drugs: ibuprofen and ketoprofen
2012
The FDA Biopharmaceutical Classification System guidance allows waivers for in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms only for BCS class I. Extensions of the in vivo biowaiver for a number of drugs in BCS class III and BCS class II have been proposed, in particular, BCS class II weak acids. However, a discrepancy between the in vivo BE results and in vitro dissolution results for BCS class II acids was recently observed. The objectives of this study were to determine the oral absorption of BCS class II weak acids via simulation software and to determine if the in vitro dissolution test with various dissolution media could be sufficient …
Risk analysis in bioequivalence and biowaiver decisions
2013
This article evaluates the current biowaiver guidance documents published by the FDA, EU and WHO from a risk based perspective. The authors introduce the use of a Failure Mode and Effect Analysis (FMEA) risk calculation tool to show that current regulatory documents implicitly limit the risk for bioinequivalence after granting a biowaiver by reduction of the incidence, improving the detection and limiting the severity of any unforeseen bioinequivalent product. In addition, the authors use the risk calculation to expose yet unexplored options for future extension of comparative in vitro tools for biowaivers.
Multivariate equivalence tests for use in pharmaceutical development.
2014
Statistical equivalence analyses are well-established parts of many studies in the biomedical sciences. Also in pharmaceutical development and manufacturing equivalence testing methods are required in order to statistically establish similarities between machines, process components, or complete processes. This article presents a choice of multivariate equivalence testing procedures for normally distributed data as generalizations of existing univariate methods. In all derived methods, variability is interpreted as nuisance parameter. The use of the proposed methods in pharmaceutical development is demonstrated with a comparative analysis of dissolution profiles.
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.
Relationships betweenin vitrodrug dissolution andin vivoresponse
2012
In recent years there has been an effort to relate manufacturing variables to the performance of the dosage form from a clinical point of view (in terms of safety and efficacy). Consequently any control strategy or the establishment of meaningful specifications should take into consideration the clinical impact on the patient. Since plasma levels are considered to be one of the most useful surrogates for clinical safety (in that bioequivalent plasma levels are considered therapeutically equivalent) and dissolution is the best surrogate for bioavailability, it is a natural consequence that dissolution be used to establish the design space in which all the formulations would have similar safe…
Logics and operators
2003
Two connectives are of special interest in metalogical investigations — the connective of implication which is important due to its connections to the notion of inference, and the connective of equivalence. The latter connective expresses, in the material sense, the fact that two sentences have the same logical value while in the strict sense it expresses the fact that two sentences are interderivable on the basis of a given logic. The process of identification of equivalent sentences relative to theories of a logic C defines a class of abstract algebras. The members of the class are called Lindenbaum-Tarski algebras of the logic C. One may abstract from the origin of these algebras and exa…