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Generic Drug - PubMed

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Last Updated: 03 June 2022

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An Interactive Generic Physiologically Based Pharmacokinetic (igPBPK) Modeling Platform to Predict Drug Withdrawal Intervals in Cattle and Swine: A Case Study on Flunixin, Florfenicol and Penicillin G.

"Violative chemical residues in edible tissue from food-producing animals are a global public health issue. " Great efforts have been made to develop physiologically based pharmacokinetic tables for estimating withdrawal intervals for extralabel prescribed drugs in food animals. This research was designed to develop a user-friendly generic PBPK system that can detect tissue residues and estimate WDIs for many drugs including flunixin, florfenicol, and penicillin G in cattle and swine. Following extralabel guidance and specific U. S. FDA-approved tolerances, estimated WDIs for both cattle and swine were close to or marginally longer than FDA-approved label withdrawal times. Following FDA-approved label or extralabel use in both cattle and swine, this PBPK platform serves as a user-friendly quantitative tool for real-time forecasts of WDIs for flunixin, florfenicol, and penicillin G, as well as other infectious products and species.

Source link: https://doi.org/10.1093/toxsci/kfac056


Generic Drug Product Development in Japan: Regulatory Updates During 2014-2019 and the Future.

"In several nations, the rise of healthcare costs is a significant issue. " Generic drug products play a key role in lowering healthcare costs because they are less costly than the original drug products, reducing healthcare expenses. The Pharmaceuticals and Medical Devices Agency conducts the regulatory investigation of generic drug products in Japan. More efforts will continue to ensure the creation of a more cost-effective and efficient generic drug product development as well as shortening of the review period for partial change acceptance. ".

Source link: https://doi.org/10.1007/s13318-021-00720-1


A Bayesian population physiologically based pharmacokinetic absorption modeling approach to support generic drug development: application to bupropion hydrochloride oral dosage forms.

"A generalizable semi-physiologically based pharmacokinetic absorption model with six gut segments and liver was developed, as part of a two-compartment systemic disposition for bupropion hydrochloride oral dosage forms was established. A Weibull function outlined the introduction of bupropion hydrochloride from immediate, sustained-, and extended-release oral dosage forms. Priors were assigned to the three bupropion formulations' in vivo release characteristics of the three bupropion formulations based on in vitro dissolution results. To determine the most important parameters for plasma bupropion concentrations and calibrated them, we used global sensitivity analysis to find the key parameters for plasma bupropion concentrations and calibrated them. For each formulation with specific drug dissolution characteristics, Markov Chain Monte Carlo samples from the joint posterior parameter analysis were used to simulate virtual crossover clinical trials for each formulation. These results can be used to ensure consistent product quality throughout the drug product life cycle and to promote manufacturing transitions.

Source link: https://doi.org/10.1007/s10928-021-09778-5

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions

* Please keep in mind that all text is summarized by machine, we do not bear any responsibility, and you should always check original source before taking any actions