Dosage assessment of valnemulin in pigs based on population pharmacokinetic and Monte Carlo simulation

Yuan, Long; Tang, You‐Zhi; Zhang, Y. X.; Sun, Jian; Luo, Xuan; Zhu, Lishan; Zhang, Z.; Wang, R.; Liu, Y. H.

doi:10.1111/jvp.12199

Cited by 3 publications

(2 citation statements)

References 45 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…A short communication reported a bioavailability of 52.6% in broilers with no information on the fed or fasted status (Sun et al., 2017 ). In pigs, a study suggested a bioavailability of 59% but the confidence on this value is low due to the fact that the animals receiving treatment by oral and intravenous routes were not comparable (Yuan et al., 2015 ).…”

Section: Introductionmentioning

confidence: 99%

Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 8: Pleuromutilins: tiamulin and valnemulin

Koutsoumanis¹,

Allende²,

Álvarez‐Ordóñez³

et al. 2021

EFS2

View full text Add to dashboard Cite

The specific concentrations of tiamulin and valnemulin in non-target feed for food-producing animals, below which there would not be an effect on the emergence of, and/or selection for, resistance in bacteria relevant for human and animal health, as well as the specific antimicrobial concentrations in feed which have an effect in terms of growth promotion/increased yield were assessed by EFSA in collaboration with EMA. Details of the methodology used for this assessment, associated data gaps and uncertainties, are presented in a separate document. To address antimicrobial resistance, the Feed Antimicrobial Resistance Selection Concentration (FARSC) model developed specifically for the assessment was applied. However, due to the lack of data on the parameters required to calculate the FARSC, it was not possible to conclude the assessment until further experimental data become available. To address growth promotion, data from scientific publications obtained from an extensive literature review were used. Levels in feed that showed to have an effect on growth promotion/ increased yield were reported for tiamulin, while for valnemulin no suitable data for the assessment were available. It was recommended to carry out studies to generate the data that are required to fill the gaps which prevented the calculation of the FARSC for these two antimicrobials.

show abstract

Section: Introductionmentioning

confidence: 99%

Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 8: Pleuromutilins: tiamulin and valnemulin

Koutsoumanis¹,

Allende²,

Álvarez‐Ordóñez³

et al. 2021

EFS2

View full text Add to dashboard Cite

show abstract

“…This approach is widely used in human medicine (DeRyke, Kuti, & Nicolau, ; Frei, Wiederhold, & Burgess, ; Roberts, Kirkpatrick, & Lipman, ; Tanigawara, Nozawa, & Tsuda, ; Turnidge & Paterson, ; Zelenitsky, Ariano, Harding, & Forrest, ). A growing interest in population pharmacokinetics and MCS applied to the assessment of anti‐infectives dosage regimens was recently shown in veterinary medicine (Black, Landersdorfer, Bulitta, Griffith, & Govendir, ; Rey et al., ; Vilalta, Giboin, Schneider, El Garch, & Fraile, ; Yuan et al., ).…”

Section: Introductionmentioning

confidence: 99%

Pharmacokinetic/pharmacodynamic evaluation of marbofloxacin as a single injection for Pasteurellaceae respiratory infections in cattle using population pharmacokinetics and Monte Carlo simulations

Paulin

Schneider

Dron

et al. 2017

Vet Pharm & Therapeutics

View full text Add to dashboard Cite

Population pharmacokinetic of marbofloxacin was investigated with 52 plasma concentration-time profiles obtained after intramuscular administration of Forcyl® in cattle. Animal's status, pre-ruminant, ruminant, or dairy cow, was retained as a relevant covariate for clearance. Monte Carlo simulations were performed using a stratification by status, and 1000 virtual disposition curves were generated in each bovine subpopulation for the recommended dosage regimen of 10 mg/kg as a single injection.The probability of target attainment (PTA) of pharmacokinetic/pharmacodynamic (PK/PD) ratios associated with clinical efficacy and prevention of resistance was determined in each simulated subpopulation. The cumulative fraction of response (CFR) of animals achieving a PK/PD ratio predictive of positive clinical outcome was then calculated for the simulated dosage regimen, taking into account the minimum inhibitory concentration (MIC) distribution of Pasteurella multocida, Mannheimia haemolytica, and Histophilus somni. When considering a ratio of AUC 0-24 hr /MIC (area under the curve/minimum inhibitory concentration) greater than 125 hr, CFRs ranging from 85% to 100% against the three Pasteurellaceae in each bovine subpopulation were achieved.The PTA of the PK/PD threshold reflecting the prevention of resistances was greater than 90% up to MPC (mutant prevention concentration) values of 1 μg/ml in preruminants and ruminants and 0.5 μg/ml in dairy cows. | INTRODUCTIONFluoroquinolones are broad-spectrum antimicrobial drugs with high therapeutic value in both human and veterinary practice. Drug exposure, measured by the area under the concentration-time curve (AUC), is used to compute the ratio between the AUC and the minimum inhibitory concentration (MIC), a surrogate pharmacokinetic/pharmacodynamic (PK/PD) efficacy index for fluoroquinolones. Interindividual variability (IIV) of drug exposure can lead to variations in the probability of clinical success. Subpopulations with specific pharmacokinetic parameters could need dosage regimen adjustments to ensure efficacy and/or minimize the risk of emergence of antimicrobial resistance.Population pharmacokinetics associated with Monte Carlo simulations (MCSs) can contribute to optimization of antimicrobial drugs dosage regimen taking into account both the variability of the PK and the PD parameters. This approach is widely used in human medicine (DeRyke, Kuti, & Nicolau, 2007;Frei, Wiederhold, & Burgess, 2008;Roberts, Kirkpatrick, & Lipman, 2011;Tanigawara, Nozawa, & Tsuda, 2012;Turnidge & Paterson, 2007;Zelenitsky, Ariano, Harding, & Forrest, 2005). A growing interest in population pharmacokinetics and MCS applied to the assessment of anti-infectives dosage regimens was recently shown in veterinary medicine (Black, Landersdorfer, Bulitta, Griffith, & Govendir, 2014;Rey et al., 2014;Vilalta, Giboin, Schneider, El Garch, & Fraile, 2014;Yuan et al., 2015). This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which per...

show abstract

Remedial Dosing Recommendations for Sirolimus Delayed or Missed Dosages Caused by Poor Medication Compliance in Pediatric Tuberous Sclerosis Complex Patients

Yang,

Jiang,

Zhu

et al. 2024

CPD

View full text Add to dashboard Cite

Background:: Delayed or missed dosages caused by poor medication compliance significantly affected the treatment of diseases in children. Aims:: The present study aimed to investigate the influence of delayed or missed dosages on sirolimus pharmacokinetics (PK) in pediatric tuberous sclerosis complex (TSC) patients and to recommend remedial dosages for nonadherent patients. Methods:: A published sirolimus population PK model in pediatric TSC patients was used to assess the influence of different nonadherence scenarios and recommend optimally remedial dosages based on Monte Carlo simulation. Thirteen nonadherent scenarios were simulated in this study, including delayed 2h, 4 h, 6 h, 8 h, 10 h, 12 h, 14 h, 16 h, 18 h, 20 h, 22 h, 23.5 h, and missed one dosage. Remedial dosing strategies contained 10-200% of scheduled dosages. The optimal remedial dosage was that with the maximum probability of returning the individual therapeutic range. Results:: For delayed or missed sirolimus dosages in pediatric TSC patients, when the delayed time was 0-8 h, 8-10 h, 10-18 h, 18-22.7 h, 22.7-24 h, 70%, 60%, 40%, 30%, 20% scheduled dosages were recommended to take immediately. When one dosage was missed, 120% of scheduled dosages were recommended at the next dose. Conclusion:: It was the first time to recommend remedial dosages for delayed or missed sirolimus therapy caused by poor medication compliance in pediatric TSC patients based on Monte Carlo simulation. Meanwhile, the present study provided a potential solution for delayed or missed dosages in clinical practice.

show abstract

Dosage assessment of valnemulin in pigs based on population pharmacokinetic and Monte Carlo simulation

Cited by 3 publications

References 45 publications

Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 8: Pleuromutilins: tiamulin and valnemulin

Maximum levels of cross‐contamination for 24 antimicrobial active substances in non‐target feed. Part 8: Pleuromutilins: tiamulin and valnemulin

Pharmacokinetic/pharmacodynamic evaluation of marbofloxacin as a single injection for Pasteurellaceae respiratory infections in cattle using population pharmacokinetics and Monte Carlo simulations

Remedial Dosing Recommendations for Sirolimus Delayed or Missed Dosages Caused by Poor Medication Compliance in Pediatric Tuberous Sclerosis Complex Patients

Contact Info

Product

Resources

About