The clinical pharmacokinetics of zolmitriptan

Cephalalgia ◽  
1997 ◽  
Vol 17 (18_suppl) ◽  
pp. 15-20 ◽  
Author(s):  
R Dixon ◽  
A Warrander
Keyword(s):  
Indoleacetic Acid ◽  
Oral Treatment ◽  
Dose Range ◽  
Parent Compound ◽  
Plasma Concentrations ◽  
Time Profile ◽  
Multiple Dosing ◽  
Clinical Pharmacokinetics ◽  
Concentration Time ◽  
Elimination Half

Zolmitriptan (Zomig™, formerly 311C90) is a novel, oral, acute treatment for migraine. In healthy volunteers it is rapidly and extensively absorbed and has favorable oral bioavailability (approximately 40%) which is not affected by concomitant food intake. On average, 75% of its eventual Cmax is achieved within 1 h of dosing. Plasma concentrations are sustained for 4 to 6 h after dosing with single or multiple peaks in the plasma concentration-time profile, reflecting continued absorption down the gastrointestinal tract. The pharmacokinetics of zolmitriptan indicate dose proportionality over the dose range of 2.5 to 50 mg and there are no significant changes on multiple dosing. Zolmitriptan is cleared by metabolism followed by urinary excretion of the metabolites. There are three major metabolites, one of which, the N-desmethyl metabolite, is active as a 5HT1D agonist and has mean plasma concentrations approximately two thirds those of the parent compound. The other two metabolites, the N-oxide and indoleacetic acid, are inactive. The elimination half lives of zolmitriptan and its metabolites are similar, approximately 3 h. Zolmitriptan and its active metabolite are minimally protein bound in the plasma (approximately 25%). In migraine patients, plasma concentrations of zolmitriptan and its metabolites are lower during a migraine attack than outside an attack. In summary, the pharmacokinetics of zolmitriptan are simple, predictable and appropriate to an acute oral treatment for migraine.

scholarly journals Enantioselective and Nonlinear Intestinal Absorption of Eflornithine in the Rat

2008 ◽  
Vol 52 (8) ◽  
pp. 2842-2848 ◽  
Author(s):  
R. Jansson ◽  
M. Malm ◽  
C. Roth ◽  
M. Ashton
Keyword(s):  
Body Weight ◽  
Liquid Chromatography ◽  
Plasma Concentration ◽  
Oral Treatment ◽  
Dose Range ◽  
Time Profile ◽  
Pharmacokinetic Data ◽  
Sprague Dawley ◽  
Limit Of Quantification ◽  
Concentration Time

ABSTRACT This study aimed to investigate if the absorption of the human African trypanosomiasis agent eflornithine was stereospecific and dose dependent after oral administration. Male Sprague-Dawley rats were administered single doses of racemic eflornithine hydrochloride as an oral solution (750, 1,500, 2,000, or 3,000 mg/kg of body weight) or intravenously (375 or 1,000 mg/kg of body weight). Sparse blood samples were obtained for determination of eflornithine enantiomers by liquid chromatography with evaporative light-scattering detection (lower limit of quantification [LLOQ], 83 μM for 300 μl plasma). The full plasma concentration-time profile of racemic eflornithine following frequent sampling was determined for another group of rats, using a high-performance liquid chromatography-UV method (LLOQ, 5 μM for 50 μl plasma). Pharmacokinetic data were analyzed in NONMEM for the combined racemic and enantiomeric concentrations. Upon intravenous administration, the plasma concentration-time profile of eflornithine was biphasic, with marginal differences in enantiomer kinetics (mean clearances of 14.5 and 12.6 ml/min/kg for l- and d-eflornithine, respectively). The complex absorption kinetics were modeled with a number of transit compartments to account for delayed absorption, transferring the drug into an absorption compartment from which the rate of influx was saturable. The mean bioavailabilities for l- and d-eflornithine were 41% and 62%, respectively, in the dose range of 750 to 2,000 mg/kg of body weight, with suggested increases to 47% and 83%, respectively, after a dose of 3,000 mg/kg of body weight. Eflornithine exhibited enantioselective absorption, with the more potent l-isomer being less favored, a finding which may help to explain why clinical attempts to develop an oral treatment have hitherto failed. The mechanistic explanation for the stereoselective absorption remains unclear.

Lack of Acipimox-Digoxin Interaction in Patient Volunteers

1992 ◽  
Vol 11 (5) ◽  
pp. 357-359 ◽  
Author(s):  
Chioli Pascal Chijioke ◽  
Richard Martin Pearson ◽  
Strolin Benedetti
Keyword(s):  
Oral Absorption ◽  
Human Subjects ◽  
Plasma Concentrations ◽  
Time Curve ◽  
Digoxin Interaction ◽  
Concentration Time ◽  
Elimination Half ◽  
Significant Difference ◽  
Before And After ◽  
Renal Clearances

1 A study was carried out to find out if digoxin and acipimox interact. 2 Six elderly patients on digoxin were each given acipimox 150 mg three daily for a week, after informed consent. Digoxin and acipimox plasma concentrations and urinary excretion were measured after the first dose of acipimox and after a week of treatment. 3 Data were fitted to a one-compartment oral absorption model. Areas under the plasma concentration-time curve, plasma and renal clearances, and elimination half-life were computed. 4 There was no significant difference in digoxin plasma concentrations and kinetic parameters before and after acipimox administration. Acipimox kinetics were not affected by the concomitant ingestion of digoxin. 5 The patients' clinical condition remained stable during the study. 6 Thus there was no evidence for an adverse interaction between digoxin and acipimox in human subjects under the conditions of this study.

Phase I study of Solulin, a novel recombinant soluble human thrombomodulin analogue

2011 ◽  
Vol 105 (02) ◽  
pp. 302-312 ◽  
Author(s):  
Thijs van Iersel ◽  
Heimo Stroissnig ◽  
Peter Giesen ◽  
Johan Wemer ◽  
Karin Wilhelm-Ogunbiyi
Keyword(s):  
Healthy Volunteers ◽  
Clinical Investigation ◽  
Dose Range ◽  
Plasma Concentrations ◽  
Human Study ◽  
Bleeding Risk ◽  
High Dose ◽  
Multiple Dosing ◽  
Relevant Dose

SummarySolulin is a novel recombinant soluble derivative of human thrombomodulin. In this first human study of Solulin, the safety, tolerability, pharmacokinetics and pharmacodynamics of Solulin in 30 healthy volunteers in response to single (0.6–30 mg) and 12 healthy volunteers in response to multiple (1 and 10 mg) ascending intravenous bolus doses compared to placebo are described. Solulin was shown to be well tolerated, and demonstrated linear pharmacokinetics over the clinically relevant dose range, with a plasma elimination half-life of 15–30 hours, indicating that a less than daily dose may be required for therapeutic use. Steady-state plasma levels after multiple dosing were reached after 48 hours. Solulin has shown to be able to inhibit thrombin generation without increasing levels of aPC/PCI complexes. Coagulation parameters INR and PT were not changed, aPTT was elevated to about 10% above the upper limit of normal after the highest single dose only. Thrombin clotting time was prolonged after administration of high dose Solulin (10, 30 mg). No effect on in vitro bleeding time has been found. There was no evidence of bleeding risk with Solulin administration. The pharmacodynamic effects correlated with Solulin plasma concentrations. This demonstrates that the antithrombotic effect of Solulin is predictable, suggesting that patient monitoring is not expected. The results of this study provide evidence that Solulin can be expected to be an effective and safe anticoagulant, and further clinical investigation is warranted.

scholarly journals Pharmacokinetic and Pharmacodynamic Evaluation of Marbofloxacin in Pig against Korean Local Isolates ofActinobacillus pleuropneumoniae

2017 ◽  
Vol 2017 ◽  
pp. 1-11 ◽  
Author(s):  
Md. Akil Hossain ◽  
Hae-chul Park ◽  
Kyunghun Jeong ◽  
Yang ho Jang ◽  
Dae Gyun Kim ◽  
...  
Keyword(s):  
Body Weight ◽  
Ex Vivo ◽  
Peak Plasma ◽  
Plasma Concentrations ◽  
Antibacterial Activities ◽  
Time Intervals ◽  
Concentration Time ◽  
Elimination Half ◽  
The Mean

The pharmacokinetics of marbofloxacin in pigs after intravenous (i.v.), intramuscular (i.m.), and peroral (p.o.) administration and pharmacokinetic/pharmacodynamic indices of this drug against Korean local isolates ofActinobacillus pleuropneumoniaewere determined in this study. Marbofloxacin (2.50 mg/kg of body weight) was administered, and blood samples were collected with designated time intervals. Plasma-extracted marbofloxacin was injected into the LC-MS/MS system. The in vitro and ex vivo antibacterial activities of marbofloxacin were evaluated against 20 isolates ofA. pleuropneumoniae. The mean peak plasma concentrations (Cmax) after i.v., i.m., and p.o administration were2.60±0.10,2.59±0.12, and2.34±0.12 µg/mL at0.25±0.00,0.44±0.10, and1.58±0.40 h, respectively. The area under the plasma concentration-time curves (AUC0–24) and elimination half-lives were24.80±0.90,25.80±1.40, and23.40±5.00 h·μg/mL and8.60±0.30,12.80±1.10, and8.60±0.00 h, for i.v., i.m., and p.o. administration, correspondingly. The AUC0–24/MICs of marbofloxacin after i.v., i.m., and p.o. administration were253.86±179.91,264.1±187.16, and239.53±169.75 h, respectively. TheCmax/MIC values were26.58±18.84,26.48±18.77, and23.94±16.97, and T>MICs were42.80±1.01,36.40±1.24, and38.60±1.18 h, after i.v., i.m., and p.o. administration, respectively. Thus, marbofloxacin dosage of 2.50 mg/kg of body weight by i.v., i.m., and p.o. administration with 24 h dosing interval will provide effective treatment for the infection of pig byA. pleuropneumonia.

The Clinical Pharmacokinetics of Quinapril

Angiology ◽  
1989 ◽  
Vol 40 (4_part_2) ◽  
pp. 351-359 ◽  
Author(s):  
Stephen C. Olson ◽  
Ann Marie Horvath ◽  
Barbara M. Michniewicz ◽  
Allen J. Sedman ◽  
Wayne A. Colburn ◽  
...  
Keyword(s):  
Half Life ◽  
Peak Plasma ◽  
Dose Range ◽  
Plasma Concentrations ◽  
Area Under The Curve ◽  
Clinical Pharmacokinetics ◽  
Q 61 ◽  
Dose Proportional

Quinapril (Q) and quinaprilat (QT) pharmacokinetics are dose pro portional following single oral 2.5- to 80-mg Q doses. Q absorption and hy drolysis to QT is rapid with peak Q and QT concentrations occurring one and two hours postdose, respectively. Peak plasma QT concentrations were approximately fourfold higher than those of Q (923 vs 207 ng/mL follow ing 40-mg Q). Dose-proportional QT area under the curve and dose-inde pendent percent of dose excreted in urine as QT demonstrate that the ex tent of Q conversion to QT is con stant over the dose range studied. Q and QT were eliminated from plasma with apparent half-lives of 0.8 and 1.9 hours and apparent plasma clear ances of 1,850 and 220 mL/min, re spectively, over the 2.5- to 80-mg dose range. Following oral 14C-Q, 61% and 37% of radiolabel was recovered in urine and feces, respectively. Q plus QT accounted for 46% of radioactiv ity circulating in plasma and 56% of that excreted in urine. Metabolism to compounds other than QT is not extensive. Two diketo piperazine metabolites of Q have been identified in plasma and urine, with approximately 6% of an admin istered dose excreted in urine as each of these metabolites. Peak plasma concentrations of these metabolites are similar to that of Q, and each is eliminated rapidly with a half-life of approximately one hour. Urinary ex cretion profiles indicate the presence of other minor metabolites. In summary, the absorption of Q and conversion to QT is rapid and dose-proportional, subsequent clear ance of both Q and QT is independ ent of dose, and metabolism to compounds other than QT is not ex tensive.

scholarly journals Clinical Pharmacokinetics of Long-Term Infusion of Midazolam in Critically Ill Patients — Preliminary Results

1987 ◽  
Vol 15 (4) ◽  
pp. 440-444 ◽  
Author(s):  
M. S. C. Dirksen ◽  
T. B. Vree ◽  
J. J. Driessen
Keyword(s):  
Intensive Care ◽  
Status Epilepticus ◽  
Bolus Injection ◽  
Plasma Concentrations ◽  
Prolonged Infusion ◽  
Main Metabolite ◽  
Clinical Pharmacokinetics ◽  
Intensive Care Patients ◽  
Elimination Half

Seven intensive care patients were sedated with prolonged infusion of midazolam. One patient received a continuous infusion of midazolam for the treatment of status epilepticus. A bolus injection of 5 mg was administered, followed by infusion of 4–14 mg/hour depending on the required level of sedation. The length of infusion varied between 80 and 360 hours. The plasma concentrations of the midazolam during infusion were between 500–1000 ng/ml. All the patients were adequately sedated. The plasma elimination half-life of midazolam and its main metabolite, 1-OH-midazolam glucuronide, after stopping the infusion varied from 4–12 hours.

scholarly journals Effect of the African Traditional Medicine,Sutherlandia frutescens, on the Bioavailability of the Antiretroviral Protease Inhibitor, Atazanavir

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Adrienne C. Müller ◽  
Michael F. Skinner ◽  
Isadore Kanfer
Keyword(s):  
Single Dose ◽  
Geometric Mean ◽  
Plasma Concentrations ◽  
Time Profile ◽  
Blood Samples ◽  
Concentration Time ◽  
The Mean ◽  
Male Subjects ◽  
Anti Hiv ◽  
Sutherlandia Frutescens

The objective of this study was to investigate the effect ofSutherlandia frutescens(SF) on the bioavailability of atazanavir (ATV) in twelve healthy male subjects. During Phase I (Day 1), subjects ingested a single dose of ATV and blood samples were drawn before dose and at 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 3.5, 4.0, 5.0, 6.0, 9.0, 12, 18, and 24 hours after dose. From Day 3 to Day 14, a single dose of milled SF was administered twice daily to each subject. During Phase II, Day 15, subjects ingested single doses of ATV and SF. Blood samples were drawn as previously described. Plasma was harvested from blood samples and the concentration of ATV therein was determined. For each phase, the mean ATV plasma concentration-time profile was plotted and the means ofAUC0–24andCmaxfor ATV were computed. The geometric mean ratios and confidence intervals (CIs) forCmaxandAUC0–24 hrwere 0.783 (0.609–1.00) and 0.801 (0.634–1.01), respectively. The CIs for both PK parameters fell below the limits of the “no-effect” boundary, set at 0.8–1.25, indicating that SF significantly reduced the bioavailability of ATV. This may potentially result in subtherapeutic plasma concentrations and thus reduced anti-HIV efficacy of ATV.

scholarly journals O07 Predictive performance of a physiologically based pharmacokinetic model of caffeine in the preterm population

2019 ◽  
Vol 104 (6) ◽  
pp. e3.2-e3
Author(s):  
A Pansari ◽  
K Abduljalil ◽  
T Johnson
Keyword(s):  
Plasma Concentration ◽  
Pharmacokinetic Model ◽  
Plasma Concentrations ◽  
Predictive Performance ◽  
Time Profile ◽  
Preterm Neonates ◽  
Pharmacokinetic Parameters ◽  
Dose Administration ◽  
Physiologically Based Pharmacokinetic ◽  
Concentration Time

BackgroundCaffeine has been extensively used in the treatment of apnoea in premature infants,1 its disposition varies with postnatal age2 and can differ markedly between premature and term neonates.MethodsThe Preterm population within the Simcyp Simulator V18R1 population library was used to replicate clinical studies to predict caffeine exposure after single3 and multiple4 intravenous administration to preterm neonates of gestational weeks 28.5 and 29 (28–33) respectively, ranging in postnatal age of 3–30 days and 0–3 days respectively. Predictive performance of the Physiologically Based Pharmacokinetic Model (PBPK) was evaluated by comparing the simulated to the clinical results. A population simulation was performed for the single dose study as only pharmacokinetic parameters were available. However, for multiple doses study, where individual plasma concentration-time profile data were available, simulations were performed for each individual.ResultsPBPK model predictions for caffeine in preterm neonates were in good agreement with the clinical observations. In the case of single dose administration, the ratios of predicted vs observed mean Volume of distribution (Vss), peak plasma concentration (Cmax), Clearance (CL) and Half-life (t1/2) were 1, 1.2, 1 and 1.1, respectively. Individual predicted concentration-time profiles following multiple dose administration were in close agreement with the observed data for all 16 subjects, overall 95% of individual observed data points were within the 5th and 95th percentile of predicted plasma concentration-time profile.ConclusionsThe predictive performance of preterm PBPK models for caffeine was found to be appropriate. A similar PBPK approach can be utilized in the clinics for the accurate prediction of pharmacokinetic parameters and plasma concentrations and for dosage adjustment to attain specific plasma concentrations of drugs in premature population.ReferencesGiacoia, et al. Effects of formula feeding on oral absorption of caffeine in premature infants. Dev Pharmacol Ther 1989; 12:205–210.Johnson, et al. Prediction of the clearance of eleven drugs and associated variability in neonates, infants and children. Clin Pharmacokinet 2006; 45(9):931–56.Aranda, et al. Population Pharmacokinetic profile of caffeine in the premature newborn infant with apnea; The Journal of Pediatrics 1979; 94(4.):663–668.Lee, et al. Caffeine in apnoeic asian neonates: a sparse data analysis. Br J Clin Pharmacol 2002; 54:31–37.Disclosure(s)Nothing to disclose

scholarly journals Comparative Clinical Pharmacokinetics and Pharmacodynamics of Investigational Once-Daily Sustained-Release (SR) Vildagliptin 100 mg Tablet Formulation with Conventional 50 mg Twice-Daily Regimen in Healthy Indian Males

2021 ◽  
Vol 04 (05) ◽  
Author(s):  
Alok Pote ◽  
Keyword(s):  
Sustained Release ◽  
Multiple Dose ◽  
Patient Adherence ◽  
Plasma Concentrations ◽  
Tablet Formulation ◽  
Daily Regimen ◽  
Post Dose ◽  
Clinical Pharmacokinetics ◽  
Once Daily ◽  
Concentration Time

Background- Among the gliptins, vildagliptin is the only therapy requiring twice-daily dosing and thus adversely impacts patient adherence. To reduce dosing frequency, we developed a once-daily sustained-release (SR) vildagliptin 100 mg tablet formulation with potential to furnish comparable dipeptidyl peptidase-4 (DPP-4) inhibition coverage to the conventional twice-daily regimen. Objective- The current study compares the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of investigational once-daily SR vildagliptin 100 mg tablet formulation with the twice-daily dosage of marketed product, Galvus® in healthy Indian adult males after single and multiple-dose administration. Methods- Single and multiple-dose PK-PD assessment was conducted in separate clinical studies enrolling thirty-six healthy subjects under fed-condition. Each study was a randomized, open-label, two treatment, two-period, crossover design. Drug plasma concentrations were quantified by validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. DPP-4 inhibition was estimated in the fluorescence-based assay. PK parameters were calculated from the plasma concentration-time curve employing Phoenix® WinNonlin® software. Formulation safety was evaluated by monitoring adverse events. Results- SR vildagliptin 100 mg tablet resulted in peak-less, nearly steady drug concentration-time profile. Thus, its mean PK characteristics after single [Cmax (147.7), AUC(0-24) (1645.04), Tmax (5.29 hr), t1/2 (4.61 hr)] and multiple-dose [Cmaxss (163.59), AUCss (0-24) (1815.36), and Tmaxss (4.65 hrs), t1/2ss (3.71 hr)] administrations were significantly distinct from the Galvus® twice-daily regimen. SR vildagliptin 100 mg tablet demonstrated more than 80% DPP-4 inhibition profile for approximately 23 hrs in both the studies which was comparable to Galvus® twice-daily regimen. Conclusions- Investigational SR vildagliptin 100 mg tablet formulation was found to be safe and well-tolerated. Its ability to provide nearly 80% DPP-4 inhibition coverage over 23 hrs post-dose may reduce the additional pill burden in patients on conventional twice-daily regimen.

scholarly journals Precision Dosing of Alemtuzumab: Population Pharmacokinetic Modeling in Pediatric Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Non-Malignant Diseases

Blood ◽  
2016 ◽  
Vol 128 (22) ◽  
pp. 2203-2203 ◽  
Author(s):  
Tsuyoshi Fukuda ◽  
Chie Emoto ◽  
Rebecca A Marsh ◽  
Lisa Neumeier ◽  
Alexander A. Vinks ◽  
...  
Keyword(s):  
Bayesian Estimation ◽  
Pediatric Patients ◽  
Hematopoietic Cell Transplantation ◽  
Plasma Concentrations ◽  
Visual Predictive Check ◽  
Time Profile ◽  
Mixed Chimerism ◽  
Concentration Time ◽  
Population Pk ◽  
Intensive Sampling

Abstract INTRODUCTION:A commonly utilized reduced intensity conditioning (RIC) for allogeneic hematopoietic cell transplantation (HCT) of patients with non-malignant disorders consists of alemtuzumab (Campath), fludarabine, and melphalan. Our group recently showed that the risks of acute graft vs host disease (GVHD) and the development of mixed chimerism following this regimen are determined by the peri-transplant levels of alemtuzumab, and recommended a potential optimal Day 0 (D0) alemtuzumab level in the range of 0.2-0.4 µg/mL (Marsh et al, Blood 2016). Additionally, patients with Day 0 alemtuzumab levels >0.6ug/mL also had delayed immune reconstitution post-transplant. We have since conducted a prospective 'intensive sampling' pharmacokinetics (PK) study of subcutaneous alemtuzumab in pediatric patients undergoing HCT (Marsh et al. EBMT Oral Presentation 2016). PK data showed a large inter-individual variability in alemtuzumab exposure and D0 levels. Importantly, levels correlated with pre-transplant absolute lymphocyte count (ALC) and underlying diagnoses. Due to the direct effects of alemtuzumab levels on important HCT outcomes, it is desirable to optimize its dosing. Ideal dosing will be where there is adequate alemtuzumab on D0 to prevent acute GVHD but not too much so as to increase the risk of mixed chimerism and/or delay early post-HCT immune recovery. In order to support targeted precision dosing of alemtuzumab in a prospective clinical trial, we have developed a population PK (PPK) model for Bayesian adaptive control. METHODS: Pediatric patients (n=17) with non-malignant disorders receiving subcutaneous alemtuzumab as a part of their preparative regimen were prospectively enrolled in our 'intensive sampling' PK study. The median age of patients was 7.0 years (3.0-11.0) and median weight was 32.2 kg (16.2-58.9). Alemtuzumab was subcutaneously administered starting on Day -14 at a dose of 0.2 mg/kg/day for 5 days (total dose of 1 mg/kg). Alemtuzumab plasma concentrations were quantified by validated flow cytometric assay. The plasma concentrations at pre-dose, 30 minutes, and 8 hours after each dose, followed by daily levels until Day 0 were used for PPK analysis. PPK analysis was performed using nonlinear mixed effects modeling (NONMEM, version 7.2). Bayesian estimation was conducted using MW/Pharm software (version 3.6). RESULTS: A one-compartment model with first order absorption best described the PK of alemtuzumab (Figure 1). Model fit was significantly improved by including body weight with allometric scaling for clearance and the volume of distribution (p<0.01). Goodness-of-fit plots did not show systematic bias. Model parameter estimates were within the 95% CIs of median values obtained by bootstrap analysis. Bayesian estimation with the developed PPK resulted in well predicted alemtuzumab concentration-time profiles in each patient (Figure 2). CONCLUSION:This is a first study to develop a PPK model of alemtuzumab after subcutaneous administration in pediatric transplant patients. Our model can be used for Bayesian estimation of individual PK to support alemtuzumab precision dosing in pediatric patients undergoing allogeneic HCT using the alemtuzumab, fludarabine, and melphalan containing RIC. Precision dosing of alemtuzumab will in turn optimize transplant outcomes for these high risk patients, by minimizing acute GVHD and mixed chimerism, along with improving post-HCT immune reconstitution. Figure 1 Visual predictive check of alemtuzumab PK model developed using pediatric data Circles: observed plasma concentrations; solid gray lines: lower (5th), middle (50th, median) and upper (95th) percentiles of the observed data; dot-dashed black lines, 5th, 50th, 95thpercentiles of the predicted data; shaded areas, confidence intervals around the prediction intervals in each bin. Figure 1. Visual predictive check of alemtuzumab PK model developed using pediatric data. / Circles: observed plasma concentrations; solid gray lines: lower (5th), middle (50th, median) and upper (95th) percentiles of the observed data; dot-dashed black lines, 5th, 50th, 95thpercentiles of the predicted data; shaded areas, confidence intervals around the prediction intervals in each bin. Figure 2 Population PK model predicted vs. Individual prediction of alemtuzumab concentration-time profile in a representative patient Dotted line: population prediction; solid line: individual prediction; circles: observed plasma concentrations. Figure 2. Population PK model predicted vs. Individual prediction of alemtuzumab concentration-time profile in a representative patient. / Dotted line: population prediction; solid line: individual prediction; circles: observed plasma concentrations. Disclosures No relevant conflicts of interest to declare.

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