| People | Locations | Statistics |
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| Naji, M. |
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| Motta, Antonella |
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| Aletan, Dirar |
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| Mohamed, Tarek |
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| Ertürk, Emre |
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| Taccardi, Nicola |
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| Kononenko, Denys |
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| Petrov, R. H. | Madrid |
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| Alshaaer, Mazen | Brussels |
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| Bih, L. |
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| Casati, R. |
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| Muller, Hermance |
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| Kočí, Jan | Prague |
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| Šuljagić, Marija |
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| Kalteremidou, Kalliopi-Artemi | Brussels |
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| Azam, Siraj |
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| Ospanova, Alyiya |
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| Blanpain, Bart |
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| Ali, M. A. |
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| Popa, V. |
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| Rančić, M. |
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| Ollier, Nadège |
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| Azevedo, Nuno Monteiro |
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| Landes, Michael |
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| Rignanese, Gian-Marco |
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Huang, W.
in Cooperation with on an Cooperation-Score of 37%
Topics
Publications (9/9 displayed)
- 2024Suspended micro thermometer for anisotropic thermal transport measurementscitations
- 2024Activation of peracetic acid by a magnetic biochar-ferrospinel AFe2O4 (A = Cu, Co, or Mn) nanocomposite for the degradation of carbamazepine − a comparative and mechanistic studycitations
- 2022Development of a pediatric physiologically-based pharmacokinetic model to support recommended dosing of atezolizumab in children with solid tumors.citations
- 2020Hybrid organic–metal oxide multilayer channel transistors with high operational stabilitycitations
- 2017Multiferroic Bi2FeCrO6 based p-i-n heterojunction photovoltaic devicescitations
- 2015Epitaxial Bi2FeCrO6 Multiferroic Thin Film as a New Visible Light Absorbing Photocathode Materialcitations
- 2006ZnCdSe-ZnSe cladded quantum dots using photoassisted microwave plasma enhanced metalorganic chemical vapor deposition for lasers and electroluminescent phosphors
- 2006ZnCdSe-ZnSe cladded quantum dots using Photoassisted Microwave Plasma (PMP) enhanced metalorganic chemical vapor deposition for lasers and electroluminescent phosphors
- 2005Selective fluorescence detection of divalent and trivalent metal ions with functionalized lipid membranescitations
Places of action
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article
Development of a pediatric physiologically-based pharmacokinetic model to support recommended dosing of atezolizumab in children with solid tumors.
Abstract
<b>Background:</b> Atezolizumab has been studied in multiple indications for both pediatric and adult patient populations. Generally, clinical studies enrolling pediatric patients may not collect sufficient pharmacokinetic data to characterize the drug exposure and disposition because of operational, ethical, and logistical challenges including burden to children and blood sample volume limitations. Therefore, mechanistic modeling and simulation may serve as a tool to predict and understand the drug exposure in pediatric patients. <b>Objective:</b> To use mechanistic physiologically-based pharmacokinetic (PBPK) modeling to predict atezolizumab exposure at a dose of 15 mg/kg (max 1,200 mg) in pediatric patients to support dose rationalization and label recommendations. <b>Methods:</b> A minimal mechanistic PBPK model was used which incorporated age-dependent changes in physiology and biochemistry that are related to atezolizumab disposition such as endogenous IgG concentration and lymph flow. The PBPK model was developed using both <i>in vitro</i> data and clinically observed data in adults and was verified across dose levels obtained from a phase I and multiple phase III studies in both pediatric patients and adults. The verified model was then used to generate PK predictions for pediatric and adult subjects ranging from 2- to 29-year-old. <b>Results:</b> Individualized verification in children and in adults showed that the simulated concentrations of atezolizumab were comparable (76% within two-fold and 90% within three-fold, respectively) to the observed data with no bias for either over- or under-prediction. Applying the verified model, the predicted exposure metrics including C<sub>min</sub>, C<sub>max</sub>, and AUC<sub>tau</sub> were consistent between pediatric and adult patients with a geometric mean of pediatric exposure metrics between 0.8- to 1.25-fold of the values in adults. <b>Conclusion:</b> The results show that a 15 mg/kg (max 1,200 mg) atezolizumab dose administered intravenously in pediatric patients provides comparable atezolizumab exposure to a dose of 1,200 mg in adults. This suggests that a dose of 15 mg/kg will provide adequate and effective atezolizumab exposure in pediatric patients from 2- to 18-year-old.