Search results for "Maximum difference"
showing 5 items of 5 documents
Defining level A IVIVC dissolution specifications based on individual in vitro dissolution profiles of a controlled release formulation.
2018
Regulatory guidelines recommend that, when a level A IVIVC is established, dissolution specification should be established using averaged data and the maximum difference between AUC and Cmax between the reference and test formulations cannot be greater than 20%. However, averaging data assumes a loss of information and may reflect a bias in the results. The objective of the current work is to present a new approach to establish dissolution specifications using a new methodology (individual approach) instead of average data (classical approach). Different scenarios were established based on the relationship between in vitro-in vivo dissolution rate coefficient using a level A IVIVC of a cont…
Safety and performance of a suprachoroidal sensor for telemetric measurement of intraocular pressure in the EYEMATE-SC trial
2023
AimTo investigate the safety and performance of a telemetric suprachoroidal intraocular pressure (IOP) sensor (EYEMATE-SC) and the accuracy of its IOP measurements in open angle glaucoma (OAG) patients undergoing simultaneous non-penetrating glaucoma surgery (NPGS).MethodsProspective, multicentre, open-label, single-arm, interventional clinical trial. Twenty-four eyes of 24 patients with OAG regularly scheduled for NPGS (canaloplasty or deep sclerectomy) were simultaneously implanted with an EYEMATE-SC sensor. Six-month follow-up on the sensor’s safety and performance as well as on the level of agreement between the EYEMATE-SC measurements and IOP measurements with Goldmann applanation tono…
Influence of the rainfall measurement interval on the erosivity determinations in the Mediterranean area
2006
Summary The single-storm erosion index, EI, of the USLE and RUSLE models may vary appreciably with the rainfall measurement interval, Δ t . However, the effect of Δ t on EI has not been investigated in the Mediterranean area. Approximately 700 erosive events and 1.5 years of rainfall energies measured by a rainfall impact measurement device were used to evaluate the effect of the rainfall measurement interval (5 min ⩽ Δ t ⩽ 60 min) on the erosivity determinations in the Mediterranean semi-arid area of Sicily. According to both literature and practical considerations, a reference time interval equal to 15 min was used in this investigation. Hourly rainfall data led to an appreciable underes…
Dynamic daylight simulations: Impact of weather file’s choice
2015
Abstract This paper is the second step of a research project aimed at investigating the impact of the use of different weather data files on daylight simulations’ results. Simulations were carried out for a simple standalone office using three weather files (IWEC, Meteonorm and Satel-Light) for two European locations (Copenhagen and Rome); moreover the office’s exposure was changed according to the four main orientations (North, East, South and West). Results were analyzed both in terms of Annual and Monthly Light Exposures, dynamic daylight performance metrics (DA, DAcon, UDI) and sunlight’s incidence. It was demonstrated that differences between the results obtained with the different wea…
Über den einfluß des lösungsmittels beim thermischen zerfall des azoisobuttersäuredinitrils
1967
Der Zerfall des Azoisobuttersauredinitrils wurde in 10 verschiedenen Losungsmitteln kinetisch untersucht. Er ist streng eine Reaktion erster Ordnung. Die Zerfallsgeschwindigkeit ist in den einzelnen Losungsmitteln verschieden. Der maximale Unterschied betragt bei 60°C 40% (Malonsaurediathylester/Cyclohexanol), entsprechend einer Differenz der Freien Enthalpie des Ubergangszustandes von 250 cal/Mol. Die starkeren Anderungen der Aktivierungsenthalpie bis zu 1,5 kcal/Mol werden durch entsprechende Anderungen der Entropie des Ubergangszustandes kompensiert. The thermal decomposition of azo-bis-isobutyronitrile in a series of 10 solvents was investigated. The reaction is strictly of first order.…