scholarly journals Reducing Palivizumab Dose Requirements Through Rational Dose Regimen Design

2018 ◽  
Vol 8 (1) ◽  
pp. 26-33
Author(s):  
Stephanie E. Reuter ◽  
Allan M. Evans ◽  
Michael B. Ward
Keyword(s):  
Dose Regimen ◽  
Rational Dose ◽  
Dose Regimen Design

Influence of dose regimen and hormonal state on the activity of an LHRH antagonist in the male rat

1984 ◽  
Vol 20 (6) ◽  
pp. 1400
Author(s):  
G.I. McRae ◽  
B.B. Roberts ◽  
A.C. Worden ◽  
W.J. Bremner ◽  
B.H. Vickery
Keyword(s):  
Dose Regimen ◽  
Male Rat ◽  
Lhrh Antagonist

Evaluation of a Fixed-Dose Regimen of 4-Factor Prothrombin Complex Concentrate for Warfarin Reversal

2021 ◽  
pp. 106002802199214
Author(s):  
Clare McMahon ◽  
Joe Halfpap ◽  
Qianqian Zhao ◽  
Ana Bienvenida ◽  
Anne E. Rose
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Dose Regimen ◽  
Prothrombin Complex Concentrate ◽  
Primary Outcome ◽  
International Normalized Ratio ◽  
Fixed Dose ◽  
Optimal Dosing ◽  
Warfarin Reversal ◽  
Higher Doses

Background: Fixed-dose (FD) regimens of 4-factor prothrombin complex concentrate (4F-PCC) may be effective for the emergent reversal of warfarin; however, the optimal dosing is unknown. Our institution transitioned to a FD regimen of 1000 or 2000 units of 4F-PCC based on indication. Objective: The purpose of this study is to report our experience with FD 4F-PCC compared with a historical weight-based dosing cohort for warfarin reversal. Methods: A retrospective analysis was conducted for 3 groups: central nervous system (CNS) bleeds regardless of international normalized ratio (INR), non-CNS bleeds with an initial INR ≤6, and non-CNS bleeds with an initial INR ≥6.1. The primary outcome of the study was achievement of the target INR. Results: There were 54 patients with a CNS bleed, 153 with a non-CNS bleed and INR ≤6, and 19 with a non-CNS bleed and INR ≥6.1. In the CNS bleeding group, weight-based and FD achieved target INR 79.4% and 70% ( P = 0.52). In the INR ≥6.1 non-CNS bleeding group, weight-based and FD achieved target INR 100% and 70% ( P = 0.21). In the INR ≤6 non-CNS bleeding group, weight-based and FD achieved target INR 86.4% and 57.5% ( P = 0.0002). Conclusion and Relevance: An FD strategy of 2000 units for warfarin reversal for CNS bleeds or INR ≥6.1 was comparable to weight-based dosing. The FD strategy of 1000 units for INR ≤6 achieved target INR less often than weight-based dosing. Application of findings suggest that higher doses may be needed to achieve target INR.

scholarly journals Bayesian dose regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics

Biometrics ◽  
2021 ◽  
Author(s):  
Emma Gerard ◽  
Sarah Zohar ◽  
Hoai‐Thu Thai ◽  
Christelle Lorenzato ◽  
Marie‐Karelle Riviere ◽  
...  
Keyword(s):  
Dose Regimen ◽  
Early Phase ◽  
Pharmacokinetics And Pharmacodynamics

scholarly journals Pharmacokinetics and Safety of Rifamycin SV after Single and Multiple Doses of MMX® Modified Release Tablets in Healthy Male and Female Volunteers

Antibiotics ◽  
2021 ◽  
Vol 10 (2) ◽  
pp. 167
Author(s):  
Andrea Francesco Daniele Di Stefano ◽  
Milko Massimiliano Radicioni ◽  
Angelo Vaccani ◽  
Alessandro Mazzetti ◽  
Luigi Maria Longo ◽  
...  
Keyword(s):  
Dose Regimen ◽  
Multiple Dose ◽  
Daily Intake ◽  
Pharmacokinetic Profile ◽  
Primary Objective ◽  
Systemic Absorption ◽  
Modified Release ◽  
Post Dose ◽  
Rifamycin Sv ◽  
Study Results

The primary objective of this single- and multiple-dose pharmacokinetic study was the investigation of rifamycin SV’s pharmacokinetic profile in plasma and urine. All the 18 enrolled healthy men and post-menopausal women received modified release tablets containing 600 mg of the oral non-absorbable antibiotic, rifamycin SV, according to a multiple dose regimen: one tablet three times a day (daily intake: 1800 mg) for 14 consecutive days. Blood sampling and urine collection were performed up to 24 h post-dose after the first dose on Days 1 and 7. On average, on Day 1, Cmax,0–24 was 5.79 ± 4.24 ng/mL and was attained in a median time of 9 h. On Day 7, all the subjects had quantifiable levels of rifamycin SV in plasma at each sampling time. After a peak concentration attained 2 h post-dose (mean ± SD concentration: 10.94 ± 16.41 ng/mL), rifamycin SV decreased in plasma to levels similar to those of Day 1. The amounts of rifamycin SV excreted in urine paralleled the plasma concentration at the corresponding times. On Day 1, the total amount excreted in urine was 0.0013%, and was 0.0029% on Day 7. The study results confirmed those of the previous Phase I study: the systemic absorption of rifamycin SV was also proved negligible after 7 days of the 600 mg t.i.d. dose regimen of the newly formulated tablets, currently under development for the treatment of several small and large intestinal pathologies, including diarrhea-predominant irritable bowel syndrome, hepatic encephalopathy, and others. Registered at ClinicalTrials.gov with the identifier NCT02969252, last updated on 26JAN18.

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