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  1. Article ; Online: Population pharmacokinetics of a triple-secured fibrinogen concentrate administered to afibrinogenaemic patients: Observed age- and body weight-related differences and consequences for dose adjustment in children.

    Bellon, Anne / Fuseau, Eliane / Roumanie, Olivier / Lamazure, Jennifer / Stevens, Wil / Dahmane, Amel / Barthez-Toullec, Malika / Golly, Dominique / Henriet, Céline / Bridey, Françoise

    British journal of clinical pharmacology

    2020  Volume 86, Issue 2, Page(s) 329–337

    Abstract: Aims: The pharmacokinetics (PK) of a triple-secured fibrinogen concentrate (FC) was assessed in patients ≥40 kg by noncompartmental analysis over a period of 14 days with multiple blood samples. Limited PK time point assessments in children lead to ... ...

    Abstract Aims: The pharmacokinetics (PK) of a triple-secured fibrinogen concentrate (FC) was assessed in patients ≥40 kg by noncompartmental analysis over a period of 14 days with multiple blood samples. Limited PK time point assessments in children lead to consideration of using Bayesian estimation for paediatric data. The objectives were (i) to define the population PK of FC in patients with afibrinogenaemia; (ii) to detect age- and body weight-related differences and consequences for dose adjustment.
    Methods: A population PK model was built using plasma fibrinogen activity data collected in 31 patients aged 1 to 48 years who had participated in a single-dose PK study with FC 0.06 g kg
    Results: A 1-compartment model with allometric scaling accounting for body weight was found to best describe the kinetics of FC. Addition of age and sex as covariates did not improve the model. Incremental in vivo recovery assessed at the end of infusion with the predicted maximal concentrations was lower, weight-adjusted clearance was higher, and fibrinogen elimination half-life was shorter in patients <40 kg than patients ≥40 kg. Interpatient variability was similar in both groups.
    Conclusion: Dosing in patients ≥40 kg based on the previous empirical finding using noncompartmental analysis where FC 1 g kg
    MeSH term(s) Afibrinogenemia/drug therapy ; Age Factors ; Bayes Theorem ; Body Weight ; Child ; Fibrinogen ; Humans
    Chemical Substances Fibrinogen (9001-32-5)
    Language English
    Publishing date 2020-01-09
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 188974-6
    ISSN 1365-2125 ; 0306-5251 ; 0264-3774
    ISSN (online) 1365-2125
    ISSN 0306-5251 ; 0264-3774
    DOI 10.1111/bcp.14147
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1118: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: The Dual Targeting of FcRn and FcγRs

    Monnet, Céline / Jacque, Emilie / de Romeuf, Christophe / Fontayne, Alexandre / Abache, Toufik / Fournier, Nathalie / Dupont, Gilles / Derache, Delphine / Engrand, Anais / Bauduin, Aurélie / Terrier, Aurélie / Seifert, Alexander / Beghin, Cécile / Longue, Alain / Masiello, Nicholas / Danino, Laetitia / Nogre, Michel / Raia, Anais / Dhainaut, Frederic /
    Fauconnier, Louis / Togbe, Dieudonnée / Reitinger, Carmen / Nimmerjahn, Falk / Stevens, Wil / Chtourou, Sami / Mondon, Philippe

    Frontiers in immunology

    2021  Volume 12, Page(s) 728322

    Abstract: Novel molecules that directly target the neonatal Fc receptor (FcRn) and/or Fc gamma receptors (FcγRs) are emerging as promising treatments for immunoglobulin G (IgG)-dependent autoimmune pathologies. Mutated Fc regions and monoclonal antibodies that ... ...

    Abstract Novel molecules that directly target the neonatal Fc receptor (FcRn) and/or Fc gamma receptors (FcγRs) are emerging as promising treatments for immunoglobulin G (IgG)-dependent autoimmune pathologies. Mutated Fc regions and monoclonal antibodies that target FcRn are currently in clinical development and hold promise for reducing the levels of circulating IgG. Additionally, engineered structures containing multimeric Fc regions allow the dual targeting of FcRn and FcγRs; however, their tolerance needs to first be validated in phase I clinical studies. Here, for the first time, we have developed a modified monomeric recombinant Fc optimized for binding to all FcRns and FcγRs without the drawback of possible tolerance associated with FcγR cross-linking. A rational approach using Fc engineering allowed the selection of LFBD192, an Fc with a combination of six mutations that exhibits improved binding to human FcRn and FcγR as well as mouse FcRn and FcγRIV. The potency of LFBD192 was compared with that of intravenous immunoglobulin (IVIg), an FcRn blocker (Fc-MST-HN), and a trimeric Fc that blocks FcRn and/or immune complex-mediated cell activation through FcγR without triggering an immune reaction in several
    MeSH term(s) Animals ; Antirheumatic Agents/metabolism ; Antirheumatic Agents/pharmacology ; Arthritis, Experimental/genetics ; Arthritis, Experimental/immunology ; Arthritis, Experimental/metabolism ; Arthritis, Experimental/prevention & control ; Autoimmunity/drug effects ; Binding, Competitive ; Complement C5a/metabolism ; Female ; Histocompatibility Antigens Class I/genetics ; Histocompatibility Antigens Class I/immunology ; Histocompatibility Antigens Class I/metabolism ; Humans ; Immunoglobulin Fc Fragments/genetics ; Immunoglobulin Fc Fragments/immunology ; Immunoglobulin Fc Fragments/metabolism ; Immunoglobulin Fc Fragments/pharmacology ; Interleukin-2/metabolism ; Jurkat Cells ; Kinetics ; Mice, Inbred C57BL ; Mice, Transgenic ; Mutation ; Phagocytosis/drug effects ; Platelet Aggregation/drug effects ; Protein Binding ; Protein Engineering ; Receptors, Fc/antagonists & inhibitors ; Receptors, Fc/genetics ; Receptors, Fc/immunology ; Receptors, Fc/metabolism ; Receptors, IgG/antagonists & inhibitors ; Receptors, IgG/genetics ; Receptors, IgG/immunology ; Receptors, IgG/metabolism ; Secretory Pathway ; Signal Transduction ; THP-1 Cells ; Mice
    Chemical Substances Antirheumatic Agents ; Histocompatibility Antigens Class I ; IL2 protein, human ; Immunoglobulin Fc Fragments ; Interleukin-2 ; Receptors, Fc ; Receptors, IgG ; Complement C5a (80295-54-1) ; Fc receptor, neonatal (TW3XAW0RCY)
    Language English
    Publishing date 2021-08-26
    Publishing country Switzerland
    Document type Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2606827-8
    ISSN 1664-3224 ; 1664-3224
    ISSN (online) 1664-3224
    ISSN 1664-3224
    DOI 10.3389/fimmu.2021.728322
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article: Combined use of zoledronic acid and 153Sm-EDTMP in hormone-refractory prostate cancer patients with bone metastases.

    Lam, Marnix G E H / Dahmane, Amel / Stevens, Wil H M / van Rijk, Peter P / de Klerk, John M H / Zonnenberg, Bernard A

    European journal of nuclear medicine and molecular imaging

    2008  Volume 35, Issue 4, Page(s) 756–765

    Abstract: Purpose: (153)Sm-ethylenediaminetetramethylenephosphonic acid (EDTMP; Quadramet) is indicated for the treatment of painful bone metastases, whereas zoledronic acid (Zometa) is indicated for the prevention of skeletal complications. Because of the ... ...

    Abstract Purpose: (153)Sm-ethylenediaminetetramethylenephosphonic acid (EDTMP; Quadramet) is indicated for the treatment of painful bone metastases, whereas zoledronic acid (Zometa) is indicated for the prevention of skeletal complications. Because of the different therapeutic effects, combining the treatments may be beneficial. Both, however, accumulate in areas with increased osteoblastic activity. Possible drug interactions were investigated.
    Methods: Patients with hormone-refractory prostate cancer were treated with 18.5 MBq/kg (153)Sm-EDTMP in weeks 1 and 3 and with 37 MBq/kg in week 15. Treatment with 4 mg zoledronic acid began in week 3 and continued every 4 weeks through week 23. In weeks 3 and 15, zoledronic acid was administered 2 days before (153)Sm-EDTMP treatment. Urine was collected 48 h after injection of (153)Sm-EDTMP, and whole-body images were obtained 6, 24 and 48 h post-injection. The effect of zoledronic acid on total bone uptake of (153)Sm-EDTMP was measured indirectly by the cumulative activity excreted in the urine in weeks 1, 3 and 15. Biodistribution, safety, tolerability and effect on prostate-specific antigen level were also studied.
    Results: The urinary excretion in week 3 divided by the urinary excretion in week 1 (baseline) times 100% was mean 98.4 +/- 11.6% (median 96.2%). From week 1 to 15, after four zoledronic acid treatments, the mean ratio was 101.9 +/- 10.7% (median 101.8%). Bioequivalence could be concluded by using a two-sample t test for both per-protocol (n = 13) and full-analysis sets (n = 18). Toxicity was comparable to of monotherapy with (153)Sm-EDTMP.
    Conclusion: Zoledronic acid treatment does not influence (153)Sm-EDTMP skeletal uptake. Combined treatment is feasible and safe.
    MeSH term(s) Bone Density Conservation Agents/adverse effects ; Bone Density Conservation Agents/therapeutic use ; Bone Neoplasms/drug therapy ; Bone Neoplasms/radiotherapy ; Bone Neoplasms/secondary ; Combined Modality Therapy ; Diphosphonates/adverse effects ; Diphosphonates/therapeutic use ; Humans ; Imidazoles/adverse effects ; Imidazoles/therapeutic use ; Injections, Intravenous ; Male ; Metabolic Clearance Rate ; Neoplasm Metastasis ; Organometallic Compounds/administration & dosage ; Organometallic Compounds/adverse effects ; Organometallic Compounds/pharmacokinetics ; Organometallic Compounds/therapeutic use ; Organophosphorus Compounds/administration & dosage ; Organophosphorus Compounds/adverse effects ; Organophosphorus Compounds/pharmacokinetics ; Organophosphorus Compounds/therapeutic use ; Prostatic Neoplasms/pathology ; Prostatic Neoplasms/radiotherapy ; Radioisotopes/administration & dosage ; Radioisotopes/adverse effects ; Radioisotopes/pharmacokinetics ; Radioisotopes/therapeutic use ; Samarium/administration & dosage ; Samarium/adverse effects ; Samarium/pharmacokinetics ; Samarium/therapeutic use
    Chemical Substances Bone Density Conservation Agents ; Diphosphonates ; Imidazoles ; Organometallic Compounds ; Organophosphorus Compounds ; Radioisotopes ; Samarium (42OD65L39F) ; zoledronic acid (6XC1PAD3KF) ; samarium Sm-153 lexidronam (745X144DZY)
    Language English
    Publishing date 2008-04
    Publishing country Germany
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 8236-3
    ISSN 1619-7089 ; 1619-7070 ; 0340-6997
    ISSN (online) 1619-7089
    ISSN 1619-7070 ; 0340-6997
    DOI 10.1007/s00259-007-0659-z
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1227: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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