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This discrepancy underscores the need to develop new in vitro dissolution methodology that better predicts in vivo response to assure the therapeutic efficacy and safety of oral drug products.
This study explored the application of 400-DS dissolution apparatus 7 for individual pellet dissolution methodology by a design of experiment approach and compared its capability with that of the USP dissolution apparatus 1 and 2 for differentiating the coat quality of sustained release pellets.
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Industry accepted in vitro dissolution methodologies expend numerous resources to emulate in vivo conditions.
Within that framework, membrane-permeation dissolution methodologies are widely used to model drug absorption.
Thus, the development of the in vivo predictive dissolution (IPD) methodology is necessitated.
In order to study the effects of initial pH, sucrose and spore concentration on oxalic and citric acid production, and consequently iron dissolution, response surface methodology based on a five-level, three-variable central composite design of experiments was employed.
The percentages of ethanol used in the studies were 5, 20 and 40% with the USP listed dissolution medium and methodology.
It is also feasible to enhance CO2 dissolution using engineering methodologies such as injecting water on top of the plume of CO2.
This article describes a specific methodology to predict API dissolution based on disintegrant chemical information obtained with NIRCI.
The present work aims to predict drug release from novel site-specific release isoniazid pellets, in USP dissolution test apparatus 3, using the response surface methodology (RS M.
The methodology involves the use of gold dissolution and cyanide consumption kinetic models incorporated into a simulator, and the definition of a performance criterion for the plant optimization.
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