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  1. AU="Fahmy, Alia"
  2. AU="Gloria Lockwood"
  3. AU="Musulin, Andrija"
  4. AU=Bernucci Claudio
  5. AU="Remor, Aline Pertile"
  6. AU="Raza, Muhammad Rafie"
  7. AU="AJ Baldwin"

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  1. Article ; Online: Evaluating the utility of therapeutic drug monitoring in the clinical use of small molecule kinase inhibitors: a review of the literature.

    Fahmy, Alia / Hopkins, Ashley M / Sorich, Michael J / Rowland, Andrew

    Expert opinion on drug metabolism & toxicology

    2021  Volume 17, Issue 7, Page(s) 803–821

    Abstract: ... ...

    Abstract Introduction
    MeSH term(s) Administration, Oral ; Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacokinetics ; Dose-Response Relationship, Drug ; Drug Monitoring/methods ; Humans ; Neoplasms/drug therapy ; Precision Medicine/methods ; Protein Kinase Inhibitors/administration & dosage ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/pharmacokinetics
    Chemical Substances Antineoplastic Agents ; Protein Kinase Inhibitors
    Language English
    Publishing date 2021-07-19
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 2214462-6
    ISSN 1744-7607 ; 1742-5255
    ISSN (online) 1744-7607
    ISSN 1742-5255
    DOI 10.1080/17425255.2021.1943357
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 6264: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Importance of between and within Subject Variability in Extracellular Vesicle Abundance and Cargo when Performing Biomarker Analyses.

    Newman, Lauren A / Fahmy, Alia / Sorich, Michael J / Best, Oliver G / Rowland, Andrew / Useckaite, Zivile

    Cells

    2021  Volume 10, Issue 3

    Abstract: Small extracellular vesicles (sEV) have emerged as a potential rich source of biomarkers in human blood and present the intriguing potential for a 'liquid biopsy' to track disease and the effectiveness of interventions. Recently, we have further ... ...

    Abstract Small extracellular vesicles (sEV) have emerged as a potential rich source of biomarkers in human blood and present the intriguing potential for a 'liquid biopsy' to track disease and the effectiveness of interventions. Recently, we have further demonstrated the potential for EV derived biomarkers to account for variability in drug exposure. This study sought to evaluate the variability in abundance and cargo of global and liver-specific circulating sEV, within (diurnal) and between individuals in a cohort of healthy subjects (
    MeSH term(s) Adolescent ; Adult ; Aged ; Biomarkers, Tumor/metabolism ; Extracellular Vesicles/metabolism ; Healthy Volunteers ; Humans ; Liquid Biopsy/methods ; Middle Aged ; Young Adult
    Chemical Substances Biomarkers, Tumor
    Language English
    Publishing date 2021-02-24
    Publishing country Switzerland
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2661518-6
    ISSN 2073-4409 ; 2073-4409
    ISSN (online) 2073-4409
    ISSN 2073-4409
    DOI 10.3390/cells10030485
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  3. Article ; Online: Relationship Between Apparent Systemic Clearance of Vemurafenib and Toxicity in Patients With Melanoma.

    Kichenadasse, Ganessan / Hughes, Jim Henry / Fahmy, Alia / Rowland, Andrew / Sorich, Michael J / Hopkins, Ashley H

    Journal of clinical pharmacology

    2021  Volume 61, Issue 9, Page(s) 1243–1248

    Abstract: Vemurafenib, a B rapidly accelerated fibrosarcoma inhibitor, is commonly used in combination of cobimetinib for the treatment of melanoma. In the current study, we evaluated the relationship between vemurafenib exposure, as measured by the estimated ... ...

    Abstract Vemurafenib, a B rapidly accelerated fibrosarcoma inhibitor, is commonly used in combination of cobimetinib for the treatment of melanoma. In the current study, we evaluated the relationship between vemurafenib exposure, as measured by the estimated apparent clearance (CL
    MeSH term(s) Aged ; Antineoplastic Agents/adverse effects ; Antineoplastic Agents/pharmacokinetics ; Antineoplastic Agents/therapeutic use ; Azetidines/therapeutic use ; Dose-Response Relationship, Drug ; Female ; Humans ; Male ; Melanoma/drug therapy ; Metabolic Clearance Rate ; Middle Aged ; Patient Acuity ; Piperidines/therapeutic use ; Prospective Studies ; Vemurafenib/adverse effects ; Vemurafenib/pharmacokinetics ; Vemurafenib/therapeutic use
    Chemical Substances Antineoplastic Agents ; Azetidines ; Piperidines ; Vemurafenib (207SMY3FQT) ; cobimetinib (ER29L26N1X)
    Language English
    Publishing date 2021-08-07
    Publishing country England
    Document type Clinical Trial, Phase II ; Clinical Trial, Phase III ; Journal Article ; Multicenter Study ; Randomized Controlled Trial
    ZDB-ID 188980-1
    ISSN 1552-4604 ; 0091-2700 ; 0021-9754
    ISSN (online) 1552-4604
    ISSN 0091-2700 ; 0021-9754
    DOI 10.1002/jcph.1882
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Uf I Zs.176: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

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  4. Article ; Online: Study of the ketohexokinase inhibitor PF-06835919 as a clinical cytochrome P450 3A inducer: Integrated use of oral midazolam and liquid biopsy.

    Qiu, Ruolun / Fonseca, Kari / Bergman, Arthur / Lin, Jian / Tess, David / Newman, Lauren / Fahmy, Alia / Useckaite, Zivile / Rowland, Andrew / Vourvahis, Manoli / Rodrigues, David

    Clinical and translational science

    2023  Volume 17, Issue 1, Page(s) e13644

    Abstract: PF-06835919, a ketohexokinase inhibitor, presented as an inducer of cytochrome P450 3A4 (CYP3A4) in vitro (human primary hepatocytes), and static mechanistic modeling exercises predicted significant induction in vivo (oral midazolam area under the plasma ...

    Abstract PF-06835919, a ketohexokinase inhibitor, presented as an inducer of cytochrome P450 3A4 (CYP3A4) in vitro (human primary hepatocytes), and static mechanistic modeling exercises predicted significant induction in vivo (oral midazolam area under the plasma concentration-time curve [AUC] ratio [AUCR] = 0.23-0.79). Therefore, a drug-drug interaction study was conducted to evaluate the effect of multiple doses of PF-06835919 (300 mg once daily × 10 days; N = 10 healthy participants) on the pharmacokinetics of a single oral midazolam 7.5 mg dose. The adjusted geometric means for midazolam AUC and its maximal plasma concentration were similar following co-administration with PF-06835919 (vs. midazolam administration alone), with ratios of the adjusted geometric means (90% confidence interval [CI]) of 97.6% (90% CI: 79.9%-119%) and 98.9% (90% CI: 76.4%-128%), respectively, suggesting there was minimal effect of PF-06835919 on midazolam pharmacokinetics. Lack of CYP3A4 induction was confirmed after the preparation of subject plasma-derived small extracellular vesicles (sEVs) and conducting proteomic and activity (midazolam 1'-hydroxylase) analysis. Consistent with the midazolam AUCR observed, the CYP3A4 protein expression fold-induction (geometric mean, 90% CI) was low in liver (0.9, 90% CI: 0.7-1.2) and non-liver (0.9, 90% CI: 0.7-1.2) sEVs (predicted AUCR = 1.0, 90% CI: 0.9-1.2). Likewise, minimal induction of CYP3A4 activity (geometric mean, 90% CI) in both liver (1.1, 90% CI: 0.9-1.3) and non-liver (0.9, 90% CI: 0.5-1.5) sEVs was evident (predicted AUCR = 0.9, 90% CI: 0.6-1.4). The results showcase the integrated use of an oral CYP3A probe (midazolam) and plasma-derived sEVs to assess a drug candidate as inducer.
    MeSH term(s) Humans ; Midazolam/pharmacokinetics ; Cytochrome P-450 CYP3A/metabolism ; Proteomics ; Pharmaceutical Preparations ; Liquid Biopsy ; Drug Interactions ; Administration, Oral
    Chemical Substances Midazolam (R60L0SM5BC) ; Cytochrome P-450 CYP3A (EC 1.14.14.1) ; Pharmaceutical Preparations
    Language English
    Publishing date 2023-12-18
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 2433157-0
    ISSN 1752-8062 ; 1752-8054
    ISSN (online) 1752-8062
    ISSN 1752-8054
    DOI 10.1111/cts.13644
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: Clinical Pharmacokinetic and Pharmacodynamic Considerations in the (Modern) Treatment of Melanoma.

    Kim, Hannah Yejin / Upadhyay, Parth J / Fahmy, Alia / Liu, Xiaoman / Duong, Janna K / Boddy, Alan V

    Clinical pharmacokinetics

    2019  Volume 58, Issue 8, Page(s) 1029–1043

    Abstract: Targeted therapies, based on identification of common oncogenic mutations such as BRAF V600E/K and monoclonal antibody immunotherapies, have transformed the treatment of melanoma. Dual mitogen-activated protein kinase (MAPK) pathway inhibition of BRAF ... ...

    Abstract Targeted therapies, based on identification of common oncogenic mutations such as BRAF V600E/K and monoclonal antibody immunotherapies, have transformed the treatment of melanoma. Dual mitogen-activated protein kinase (MAPK) pathway inhibition of BRAF V600E/K and MEK 1/2 kinases with BRAF-MEK inhibitors using dabrafenib-trametinib, vemurafenib-cobimetinib and encorafenib-binimetinib is now the standard of care for BRAF V600E/K tumours. Monoclonal antibodies, such as pembrolizumab and nivolumab, against programmed cell death protein (PD-1) on T cells, as well as ipilimumab against cytotoxic T lymphocyte antigen-4 (CTLA-4), enable restoration of suppressed T-cell antitumour response, and have also shown improved clinical benefit compared with traditional chemotherapy. Exploration of different combination therapies, sequence of treatment, and dosing strategies is ongoing, and the understanding of the pharmacokinetics (PK) and pharmacodynamics (PD) of these new agents is fundamental in devising the optimal regimen. Preclinical and clinical studies, as well as population PK modelling, provide essential data in terms of PK parameters, metabolism, interpatient variability, drug interactions and PD effects at the target. This review gathers the current evidence and understanding of the clinical PK and PD of drugs used in the modern treatment of melanoma, and the factors determining drug disposition, exposure and clinical response, and also highlighting areas of further research.
    MeSH term(s) Antibodies, Monoclonal/pharmacokinetics ; Antibodies, Monoclonal/therapeutic use ; Antineoplastic Combined Chemotherapy Protocols/pharmacokinetics ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Biomarkers/metabolism ; Carcinogenesis/drug effects ; Carcinogenesis/genetics ; Combined Modality Therapy/methods ; Female ; Humans ; Male ; Melanoma/drug therapy ; Melanoma/genetics ; Mitogen-Activated Protein Kinases/antagonists & inhibitors ; Molecular Targeted Therapy/methods ; Mutation ; Pharmacogenetics/methods ; Protein Kinase Inhibitors/pharmacokinetics ; Protein Kinase Inhibitors/therapeutic use ; Tumor Microenvironment/genetics
    Chemical Substances Antibodies, Monoclonal ; Biomarkers ; Protein Kinase Inhibitors ; Mitogen-Activated Protein Kinases (EC 2.7.11.24)
    Language English
    Publishing date 2019-03-11
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 197627-8
    ISSN 1179-1926 ; 0312-5963
    ISSN (online) 1179-1926
    ISSN 0312-5963
    DOI 10.1007/s40262-019-00753-5
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1246: 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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  6. Article ; Online: Exploring the Use of Serum-Derived Small Extracellular Vesicles as Liquid Biopsy to Study the Induction of Hepatic Cytochromes P450 and Organic Anion Transporting Polypeptides.

    Rodrigues, A David / van Dyk, Madelé / Sorich, Michael J / Fahmy, Alia / Useckaite, Zivile / Newman, Lauren A / Kapetas, Asha J / Mounzer, Reham / Wood, Linda S / Johnson, Jillian G / Rowland, Andrew

    Clinical pharmacology and therapeutics

    2021  Volume 110, Issue 1, Page(s) 248–258

    Abstract: Liver-derived small extracellular vesicles (sEVs), prepared from small sets of banked serum samples using a novel two-step protocol, were deployed as liquid biopsy to study the induction of cytochromes P450 (CYP3A4, CYP3A5, and CYP2D6) and organic anion ... ...

    Abstract Liver-derived small extracellular vesicles (sEVs), prepared from small sets of banked serum samples using a novel two-step protocol, were deployed as liquid biopsy to study the induction of cytochromes P450 (CYP3A4, CYP3A5, and CYP2D6) and organic anion transporting polypeptides (OATP1B1 and OATP1B3) during pregnancy (nonpregnant (T0), first, second, and third (T3) trimester women; N = 3 each) and after administration of rifampicin (RIF) to healthy male subjects. Proteomic analysis revealed induction (mean fold-increase, 90% confidence interval) of sEV CYP3A4 after RIF 300 mg × 7 days (3.5, 95% CI = 2.5-4.5, N = 4, P = 0.029) and 600 mg × 14 days (3.7, 95% CI = 2.1-6.0, N = 5, P = 0.018) consistent with the mean oral midazolam area under the plasma concentration time curve (AUC) ratio in the same subjects (0.28, 95% CI = 0.22-0.34, P < 0.0001; and 0.17, 95% CI = 0.13-0.22, P < 0.0001). Compared with CYP3A4, liver sEV CYP3A5 protein (subjects genotyped CYP3A5*1/*3) was weakly induced (≤ 1.5-fold). It was also possible to measure liver sEV-catalyzed dextromethorphan (DEX) O-demethylation to dextrorphan (DXO), correlated with sEV CYP2D6 expression (r = 0.917, P = 0.0001; N = 10) and 3-hour plasma DXO-to-DEX concentration ratio (r = 0.843, P = 0.002, N = 10), and show that CYP2D6 was not induced by RIF. Nonparametric analysis of liver sEV revealed significantly higher CYP3A4 (3.2-fold, P = 0.003) and CYP2D6 (3.7-fold, P = 0.03) protein expression in T3 vs. T0 women. In contrast, expression of both OATPs in liver sEV was unaltered by RIF administration and pregnancy.
    MeSH term(s) Adult ; Area Under Curve ; Cytochrome P-450 Enzyme System/genetics ; Cytochrome P-450 Enzyme System/metabolism ; Dextromethorphan/pharmacokinetics ; Enzyme Induction/drug effects ; Enzyme Induction/genetics ; Extracellular Vesicles/metabolism ; Female ; Genotype ; Humans ; Liquid Biopsy ; Liver/enzymology ; Liver/metabolism ; Male ; Midazolam/pharmacokinetics ; Organic Anion Transporters/metabolism ; Pregnancy ; Proteomics ; Rifampin/pharmacology ; Young Adult
    Chemical Substances Organic Anion Transporters ; Dextromethorphan (7355X3ROTS) ; Cytochrome P-450 Enzyme System (9035-51-2) ; Midazolam (R60L0SM5BC) ; Rifampin (VJT6J7R4TR)
    Language English
    Publishing date 2021-04-18
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 123793-7
    ISSN 1532-6535 ; 0009-9236
    ISSN (online) 1532-6535
    ISSN 0009-9236
    DOI 10.1002/cpt.2244
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 20: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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