Search results for "Equivalence"
showing 10 items of 301 documents
Gravitational Waves and Gamma-Rays from a Binary Neutron Star Merger: GW170817 and GRB 170817A
2017
On 2017 August 17, the gravitational-wave event GW170817 was observed by the Advanced LIGO and Virgo detectors, and the gamma-ray burst (GRB) GRB 170817A was observed independently by the Fermi Gamma-ray Burst Monitor, and the Anticoincidence Shield for the Spectrometer for the International Gamma-Ray Astrophysics Laboratory. The probability of the near-simultaneous temporal and spatial observation of GRB 170817A and GW170817 occurring by chance is $5.0\times 10^{-8}$. We therefore confirm binary neutron star mergers as a progenitor of short GRBs. The association of GW170817 and GRB 170817A provides new insight into fundamental physics and the origin of short gamma-ray bursts. We use the ob…
Flots de Smale en dimension 3: présentations finies de voisinages invariants d'ensembles selles
2002
Abstract Given a vector field X on a compact 3-manifold, and a hyperbolic saddle-like set K of that vector field, we consider all the filtering neighbourhood of K: by such, we mean any submanifold which boundary is tranverse to X, the maximal invariant of which is equal to K and which intersection with every orbit of X is connected. Up to topological equivalence, there is only a finite number of such neighbourhoods. We give a finite combinatorial presentation of the global dynamics on any such neighbourhood. A key step is the construction of a unique model of the germ of X along K; this model is, roughly speaking, the simplest three-dimensional manifold and the simplest Smale flow exhibitin…
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Bisoprolol Fumarate
2014
Abstract Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate-release (IR) solid oral dosage forms containing bisoprolol as the sole active pharmaceutical ingredient (API) are reviewed. Bisoprolol is classified as a Class I API according to the current Biopharmaceutics Classification System (BCS). In addition to the BCS class, its therapeutic index, pharmacokinetic properties, data related to the possibility of excipient interactions, and reported BE/bioavailability problems are taken into consideration. Qualitative compositions of IR tablet dosage forms of bisoprolol with a marketing authorization (MA) in ICH (Inter…
Biowaiver Monograph for Immediate-Release Solid Oral Dosage Forms: Moxifloxacin Hydrochloride.
2020
Abstract In this monograph, literature data is reviewed to evaluate the feasibility of waiving in vivo bioequivalence testing and instead applying the Biopharmaceutics Classification System (BCS) based methods to the approval of immediate-release solid oral dosage forms containing moxifloxacin hydrochloride as the sole active pharmaceutical ingredient. To facilitate the feasibility decision, solubility and permeability and dissolution characteristics in the context of the BCS, therapeutic index, therapeutic use, pharmacokinetic parameters, bioequivalence/bioavailability issues, drug-excipient interactions and other relevant data were taken into consideration. Moxifloxacin is a BCS class I d…
Novel insights into excipient effects on the biopharmaceutics of APIs from different BCS classes: Lactose in solid oral dosage forms
2014
Excipients encompass a wide range of properties that are of importance for the resulting drug product. Regulatory guidelines on biowaivers for immediate release formulations require an in depth understanding of the biopharmaceutic effects of excipients in order to establish bioequivalence between two different products carrying the same API based on dissolution tests alone. This paper describes a new approach in evaluating biopharmaceutic excipient effects. Actually used quantities of a model excipient, lactose, formulated in combination with APIs from different BCS classes were evaluated. The results suggest that companies use different (relative) amounts depending on the characteristics o…
Candesartan Cilexetil In Vitro-In Vivo Correlation: Predictive Dissolution as a Development Tool
2020
[EN] The main objective of this investigation was to develop an in vitro-in vivo correlation (IVIVC) for immediate release candesartan cilexetil formulations by designing an in vitro dissolution test to be used as development tool. The IVIVC could be used to reduce failures in future bioequivalence studies. Data from two bioequivalence studies were scaled and combined to obtain the dataset for the IVIVC. Two-step and one-step approaches were used to develop the IVIVC. Experimental solubility and permeability data confirmed candesartan cilexetil. Biopharmaceutic Classification System (BCS) class II candesartan average plasma profiles were deconvoluted by the Loo-Riegelman method to obtain th…
High-flow nasal therapy versus noninvasive ventilation in COPD patients with mild-to-moderate hypercapnic acute respiratory failure: study protocol f…
2019
Background Noninvasive ventilation (NIV) is indicated to treat respiratory acidosis due to exacerbation of chronic obstructive pulmonary disease (COPD). Recent nonrandomized studies also demonstrated some physiological effects of high-flow nasal therapy (HFNT) in COPD patients. We designed a prospective, unblinded, multicenter, randomized controlled trial to assess the noninferiority of HFNT compared to NIV with respect to the reduction of arterial partial pressure of carbon dioxide (PaCO2) in patients with hypercapnic acute respiratory failure with mild-to-moderate respiratory acidosis. Methods We will enroll adult patients with acute hypercapnic respiratory failure, as defined by arterial…
The dual equivalence of equations and coequations for automata
2015
The transition structure α : X ? X A of a deterministic automaton with state set X and with inputs from an alphabet A can be viewed both as an algebra and as a coalgebra. We use this algebra-coalgebra duality as a common perspective for the study of equations and coequations. For every automaton ( X , α ) , we define two new automata: free ( X , α ) and cofree ( X , α ) representing, respectively, the greatest set of equations and the smallest set of coequations satisfied by ( X , α ) . Both constructions are shown to be functorial. Our main result is that the restrictions of free and cofree to, respectively, preformations of languages and to quotients A * / C of A * with respect to a congr…
A modified applicative criterion of the physical model concept for evaluating plot soil erosion predictions
2015
Abstract In this paper, the physical model concept by Nearing (1998. Catena 32: 15–22) was assessed. Soil loss data collected on plots of different widths (2–8 m), lengths (11–44 m) and steepnesses (14.9–26.0%), equipped in south and central Italy, were used. Differences in width between plots of given length and steepness determined a lower data correlation and more deviation of the fitted regression line from the identity one. A coefficient of determination between measured, M , and predicted, P , soil losses of 0.77 was representative of the best-case prediction scenario, according to Nearing (1998). The relative differences, Rdiff = ( P − M ) / ( P + M ), decreased in absolute value a…
Weak associativity and restricted rotation
2009
A restricted rotation induced by a weak associative law is introduced. The corresponding equivalence relation is identical to the Glivenko congruence on Tamari lattices, i.e. lattices of binary trees endowed by the well-known rotation operation.