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Wyświetlanie 1-20 z 31
Tytuł:
Evaluation of the drug-drug interaction potential of brigatinib using a physiologically-based pharmacokinetic modeling approach.
Autorzy:
Hanley MJ; Clinical Pharmacology, Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Yeo KR; Simcyp Division, Certara UK Limited, Sheffield, South Yorkshire, UK.
Tugnait M; Clinical Pharmacology, Cerevel Therapeutics, Cambridge, Massachusetts, USA.
Iwasaki S; Global DMPK, Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Narasimhan N; DMPK & Preclinical Safety, Theseus Pharmaceuticals, Cambridge, Massachusetts, USA.
Zhang P; Clinical Science, Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Venkatakrishnan K; Quantitative Pharmacology, EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
Gupta N; Clinical Pharmacology, Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Apr; Vol. 13 (4), pp. 624-637. Date of Electronic Publication: 2024 Jan 30.
Typ publikacji:
Journal Article
MeSH Terms:
Carcinoma, Non-Small-Cell Lung*
Lung Neoplasms*
Organophosphorus Compounds*
Pyrimidines*
Humans ; Rifampin/pharmacokinetics ; Cytochrome P-450 CYP3A Inhibitors/pharmacology ; Itraconazole/pharmacology ; Cytochrome P-450 CYP3A/metabolism ; ATP Binding Cassette Transporter, Subfamily G, Member 2 ; Neoplasm Proteins/metabolism ; Cytochrome P-450 CYP3A Inducers/pharmacokinetics ; Drug Interactions ; Membrane Transport Proteins ; Receptor Protein-Tyrosine Kinases/metabolism ; Models, Biological
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Immunogenicity of avelumab in patients with metastatic Merkel cell carcinoma or advanced urothelial carcinoma.
Autorzy:
Hu P; EMD Serono, Billerica, Massachusetts, USA.
Dai HI; EMD Serono, Billerica, Massachusetts, USA.
Bourdage J; the healthcare business of Merck KGaA, Darmstadt, Germany.
Zhou D; the healthcare business of Merck KGaA, Darmstadt, Germany.
Trang K; the healthcare business of Merck KGaA, Darmstadt, Germany.
Kowalski K; Pfizer, La Jolla, California, USA.
Bello C; Pfizer, San Diego, California, United States.
Hibma J; Pfizer, San Diego, California, United States.
Khandelwal A; the healthcare business of Merck KGaA, Darmstadt, Germany.
Cowan K; the healthcare business of Merck KGaA, Darmstadt, Germany.
Dong J; EMD Serono, Billerica, Massachusetts, USA.
Venkatakrishnan K; EMD Serono, Billerica, Massachusetts, USA.
Gao W; EMD Serono, Billerica, Massachusetts, USA.
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Źródło:
Clinical and translational science [Clin Transl Sci] 2024 Mar; Vol. 17 (3), pp. e13730.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Carcinoma, Merkel Cell*/drug therapy
Carcinoma, Merkel Cell*/pathology
Carcinoma, Transitional Cell*/drug therapy
Skin Neoplasms*/drug therapy
Skin Neoplasms*/pathology
Urinary Bladder Neoplasms*
Humans ; Antibodies, Monoclonal, Humanized/adverse effects ; Clinical Trials as Topic
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Model-based meta-analysis using latent variable modeling to set benchmarks for new treatments of systemic lupus erythematosus.
Autorzy:
Goteti K; EMD Serono Research and Development Institute, Inc., Billerica, Massachusetts, USA.
Garcia R; Metrum Research Group, Tariffville, Connecticut, USA.
Gillespie WR; Metrum Research Group, Tariffville, Connecticut, USA.
French J; Metrum Research Group, Tariffville, Connecticut, USA.
Klopp-Schulze L; Merck KGaA, Darmstadt, Germany.
Li Y; EMD Serono Research and Development Institute, Inc., Billerica, Massachusetts, USA.; Merck KGaA, Darmstadt, Germany.
Mateo CV; EMD Serono Research and Development Institute, Inc., Billerica, Massachusetts, USA.
Roy S; Ares Trading S.A, Eysins, Switzerland.
Guenther O; Merck KGaA, Darmstadt, Germany.
Benincosa L; EMD Serono Research and Development Institute, Inc., Billerica, Massachusetts, USA.
Venkatakrishnan K; EMD Serono Research and Development Institute, Inc., Billerica, Massachusetts, USA.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Feb; Vol. 13 (2), pp. 281-295. Date of Electronic Publication: 2023 Dec 04.
Typ publikacji:
Meta-Analysis; Journal Article
MeSH Terms:
Benchmarking*
Lupus Erythematosus, Systemic*/drug therapy
Humans ; Latent Class Analysis ; Bayes Theorem ; Treatment Outcome
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Tumor growth inhibition modeling in patients with second line biliary tract cancer and first line non-small cell lung cancer based on bintrafusp alfa trials.
Autorzy:
Milenković-Grišić AM; The healthcare business of Merck KGaA, Darmstadt, Germany.
Terranova N; Quantitative Pharmacology, Ares Trading S.A. (an affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.
Mould DR; Projections Research Inc, Phoenixville, Pennsylvania, USA.
Vugmeyster Y; EMD Serono, Billerica, Massachusetts, USA.
Mrowiec T; The healthcare business of Merck KGaA, Darmstadt, Germany.
Machl A; EMD Serono, Billerica, Massachusetts, USA.
Girard P; Quantitative Pharmacology, Ares Trading S.A. (an affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.
Venkatakrishnan K; EMD Serono, Billerica, Massachusetts, USA.
Khandelwal A; The healthcare business of Merck KGaA, Darmstadt, Germany.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2024 Jan; Vol. 13 (1), pp. 143-153. Date of Electronic Publication: 2023 Dec 13.
Typ publikacji:
Journal Article
MeSH Terms:
Carcinoma, Non-Small-Cell Lung*/drug therapy
Carcinoma, Non-Small-Cell Lung*/pathology
Lung Neoplasms*/drug therapy
Lung Neoplasms*/pathology
Biliary Tract Neoplasms*/drug therapy
Humans
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
A multistate modeling and simulation framework to learn dose-response of oncology drugs: Application to bintrafusp alfa in non-small cell lung cancer.
Autorzy:
Liu H; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Milenković-Grišić AM; Merck Healthcare KGaA, Darmstadt, Germany.
Krishnan SM; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Jönsson S; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Friberg LE; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
Girard P; Merck Institute of Pharmacometrics, an affiliate of Merck KGaA, Lausanne, Switzerland.
Venkatakrishnan K; EMD Serono Research & Development Institute, Inc., an affiliate of Merck KGaA, Billerica, Massachusetts, USA.
Vugmeyster Y; EMD Serono Research & Development Institute, Inc., an affiliate of Merck KGaA, Billerica, Massachusetts, USA.
Khandelwal A; Merck Healthcare KGaA, Darmstadt, Germany.
Karlsson MO; Department of Pharmacy, Uppsala University, Uppsala, Sweden.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 Nov; Vol. 12 (11), pp. 1738-1750. Date of Electronic Publication: 2023 May 11.
Typ publikacji:
Journal Article
MeSH Terms:
Carcinoma, Non-Small-Cell Lung*
Lung Neoplasms*/pathology
Humans ; Progression-Free Survival ; Computer Simulation ; Probability ; B7-H1 Antigen/therapeutic use
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Modeling tumor size dynamics based on real-world electronic health records and image data in advanced melanoma patients receiving immunotherapy.
Autorzy:
Courlet P; Precision Oncology Center, Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.; Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Abler D; Precision Oncology Center, Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.; Institute of Informatics, School of Management, University of Applied Sciences Western Switzerland (HES-SO), Sierre, Switzerland.
Guidi M; Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.; Service of Clinical Pharmacology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Girard P; Merck Institute of Pharmacometrics, Ares Trading S.A. (an affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.
Amato F; Swiss Data Science Centre, École Polytechnique Fédérale de Lausanne (EPFL) and Eidgenössische Technische Hochschule Zurich (ETH), Zurich, Switzerland.
Vietti Violi N; Department of Radiology and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Dietz M; Nuclear Medicine and Molecular Imaging Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Guignard N; Department of Radiology and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Wicky A; Precision Oncology Center, Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Latifyan S; Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
De Micheli R; Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Jreige M; Nuclear Medicine and Molecular Imaging Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Dromain C; Department of Radiology and Interventional Radiology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Csajka C; Centre for Research and Innovation in Clinical Pharmaceutical Sciences, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.; Institute of Pharmaceutical Sciences of Western Switzerland, University of Geneva, University of Lausanne, Geneva, Switzerland.; School of Pharmaceutical Sciences, University of Geneva, Geneva, Switzerland.
Prior JO; Nuclear Medicine and Molecular Imaging Department, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Venkatakrishnan K; EMD Serono Research and Development Institute, Inc, Billerica, Massachusetts, USA.
Michielin O; Precision Oncology Center, Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.
Cuendet MA; Precision Oncology Center, Department of Oncology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland.; Swiss Institute of Bioinformatics, University of Lausanne, Lausanne, Switzerland.; Department of Physiology and Biophysics, Weill Cornell Medicine, New York, New York, USA.
Terranova N; Merck Institute of Pharmacometrics, Ares Trading S.A. (an affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 Aug; Vol. 12 (8), pp. 1170-1181. Date of Electronic Publication: 2023 Jun 16.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Electronic Health Records*
Melanoma*/drug therapy
Melanoma*/pathology
Humans ; Nivolumab ; Ipilimumab ; Immunotherapy/methods
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Effect of Pevonedistat, an Investigational NEDD8-Activating Enzyme Inhibitor, on the QTc Interval in Patients With Advanced Solid Tumors.
Autorzy:
Zhou X; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Richardson DL; Stephenson Cancer Center, University of Oklahoma Health Sciences Center and Sarah Cannon Research Institute, Oklahoma City, Oklahoma, USA.
Dowlati A; Case Western Reserve University, Cleveland, Ohio, USA.
Goel S; Montefiore Medical Center, Bronx, New York, USA.
Sahebjam S; University of South Florida H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida, USA.
Strauss J; Mary Crowley Cancer Research, Dallas, Texas, USA.
Chawla S; Sarcoma Oncology Center, Santa Monica, California, USA.
Wang D; Henry Ford Hospital, Detroit, Michigan, USA.
Mould DR; Projections Research Inc., Phoenixville, Pennsylvania, USA.
Samnotra V; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Faller DV; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Venkatakrishnan K; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Gupta N; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2023 Mar; Vol. 12 (3), pp. 257-266. Date of Electronic Publication: 2022 Nov 16.
Typ publikacji:
Randomized Controlled Trial; Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Electrocardiography*
Neoplasms*/drug therapy
Neoplasms*/pathology
Humans ; Heart ; Enzyme Inhibitors ; NEDD8 Protein
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Variable or variate? A conundrum in pharmacometrics exposure-response models.
Autorzy:
Grisic AM; The Healthcare Business of Merck KGaA, Darmstadt, Germany.
Venkatakrishnan K; EMD Serono, Billerica, Massachusetts, USA.
French J; Metrum Research Group, Tariffville, Connecticut, USA.
Khandelwal A; The Healthcare Business of Merck KGaA, Darmstadt, Germany.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 Feb; Vol. 12 (2), pp. 144-147. Date of Electronic Publication: 2022 Dec 29.
Typ publikacji:
Journal Article
MeSH Terms:
Pharmacology, Clinical*
Humans ; Writing
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Disease trajectory of SLE clinical endpoints and covariates affecting disease severity and probability of response: Analysis of pooled patient-level placebo (Standard-of-Care) data to enable model-informed drug development.
Autorzy:
Goteti K; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
French J; Metrum Research Group, Tariffville, Connecticut, USA.
Garcia R; Metrum Research Group, Tariffville, Connecticut, USA.
Li Y; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Casset-Semanaz F; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Aydemir A; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Townsend R; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Mateo CV; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Studham M; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Guenther O; Merck KGaA, Darmstadt, Germany.
Kao A; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Gastonguay M; Metrum Research Group, Tariffville, Connecticut, USA.
Girard P; Merck Institute of Pharmacometrics, Lausanne, Switzerland.
Benincosa L; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Venkatakrishnan K; EMD Serono Research and Development Institute, Inc (an affiliate of Merck KGaA, Darmstadt Germany), Billerica, Massachusetts, USA.
Pokaż więcej
Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2023 Feb; Vol. 12 (2), pp. 180-195. Date of Electronic Publication: 2022 Nov 29.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal, Humanized*/therapeutic use
Lupus Erythematosus, Systemic*/drug therapy
Lupus Erythematosus, Systemic*/diagnosis
Humans ; Severity of Illness Index ; Treatment Outcome ; Immunosuppressive Agents/therapeutic use ; Patient Acuity ; Probability
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Risk assessment of drug-drug interaction potential for bintrafusp alfa with cytochrome P4503A4 substrates: A totality of evidence approach.
Autorzy:
Vugmeyster Y; EMD Serono, Billerica, Massachusetts, USA.
Locke G; EMD Serono, Billerica, Massachusetts, USA.
Helwig C; The Healthcare Business of Merck KGaA, Darmstadt, Germany.
Rolfe PA; EMD Serono, Billerica, Massachusetts, USA.
Dong JQ; EMD Serono, Billerica, Massachusetts, USA.
Venkatakrishnan K; EMD Serono, Billerica, Massachusetts, USA.
Pokaż więcej
Źródło:
Clinical and translational science [Clin Transl Sci] 2022 Dec; Vol. 15 (12), pp. 2838-2843. Date of Electronic Publication: 2022 Oct 06.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Cytochrome P-450 CYP3A*/metabolism
Recombinant Fusion Proteins*/pharmacology
Humans ; Drug Interactions ; Risk Assessment ; RNA, Messenger/genetics ; Transforming Growth Factor beta
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Designing phase I oncology dose escalation using dose-exposure-toxicity models as a complementary approach to model-based dose-toxicity models.
Autorzy:
Pantoja K; Department of Statistics, Texas A&M University, College Station, Texas, USA.; EMD Serono Research Institute, Billerica, Massachusetts, USA.
Lanke S; EMD Serono Research Institute, Billerica, Massachusetts, USA.
Munafo A; Merck Institute for Pharmacometrics, Lausanne, Switzerland.
Victor A; Merck KGaA, Darmstadt, Germany.
Habermehl C; Merck KGaA, Darmstadt, Germany.
Schueler A; Merck KGaA, Darmstadt, Germany.
Venkatakrishnan K; EMD Serono Research Institute, Billerica, Massachusetts, USA.
Girard P; Merck Institute for Pharmacometrics, Lausanne, Switzerland.
Goteti K; EMD Serono Research Institute, Billerica, Massachusetts, USA.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2022 Oct; Vol. 11 (10), pp. 1371-1381. Date of Electronic Publication: 2022 Aug 05.
Typ publikacji:
Journal Article
MeSH Terms:
Antineoplastic Agents*/toxicity
Neoplasms*/drug therapy
Bayes Theorem ; Dose-Response Relationship, Drug ; Humans ; Reproducibility of Results
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
How resilient were we in 2021? Results of a LinkedIn Survey including biomedical and pharmaceutical professionals using the Benatti Resiliency Model.
Autorzy:
Zheng S; Adagene Inc., San Diego, California, USA.
Venkatakrishnan K; EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.; A Business of Merck KGaA, Darmstadt, Germany.
Kennedy BB; Benatti Leadership Development, Beverly, Massachusetts, USA.
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Źródło:
Clinical and translational science [Clin Transl Sci] 2022 Oct; Vol. 15 (10), pp. 2355-2365. Date of Electronic Publication: 2022 Aug 18.
Typ publikacji:
Journal Article
MeSH Terms:
Leadership*
Humans ; Surveys and Questionnaires ; Pharmaceutical Preparations
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Alternatives to rifampicin: A review and perspectives on the choice of strong CYP3A inducers for clinical drug-drug interaction studies.
Autorzy:
Bolleddula J; Quantitative Pharmacology, EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
Gopalakrishnan S; Merck KGaA, Darmstadt, Germany.
Hu P; Quantitative Pharmacology, EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
Dong J; Quantitative Pharmacology, EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
Venkatakrishnan K; Quantitative Pharmacology, EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
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Źródło:
Clinical and translational science [Clin Transl Sci] 2022 Sep; Vol. 15 (9), pp. 2075-2095. Date of Electronic Publication: 2022 Jul 25.
Typ publikacji:
Journal Article; Review
MeSH Terms:
Cytochrome P-450 CYP3A Inducers*/pharmacology
Rifampin*/pharmacology
Cytochrome P-450 CYP3A ; Cytochrome P-450 CYP3A Inhibitors ; Drug Interactions ; Humans
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Population pharmacokinetic/pharmacodynamic joint modeling of ixazomib efficacy and safety using data from the pivotal phase III TOURMALINE-MM1 study in multiple myeloma patients.
Autorzy:
Srimani JK; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Diderichsen PM; Certara USA, Inc., Princeton, New Jersey, USA.
Hanley MJ; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Venkatakrishnan K; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Labotka R; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
Gupta N; Takeda Development Center Americas, Inc. (TDCA), Lexington, Massachusetts, USA.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2022 Aug; Vol. 11 (8), pp. 1085-1099. Date of Electronic Publication: 2022 Jun 13.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Boron Compounds*/adverse effects
Glycine*/adverse effects
Glycine*/analogs & derivatives
Multiple Myeloma*/drug therapy
Clinical Trials, Phase III as Topic ; Diarrhea ; Exanthema ; Humans ; Neoplasm Recurrence, Local/drug therapy ; Prospective Studies ; Silicates
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Population pharmacokinetic and exposure-response analyses from ALTA-1L: Model-based analyses supporting the brigatinib dose in ALK-positive NSCLC.
Autorzy:
Gupta N; Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Reckamp KL; Samuel Oschin Cancer Center, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Camidge DR; University of Colorado Cancer Center, Aurora, Colorado, USA.
Kleijn HJ; Certara, Princeton, New Jersey, USA.
Ouerdani A; Certara, Princeton, New Jersey, USA.
Bellanti F; Certara, Princeton, New Jersey, USA.
Maringwa J; Certara, Princeton, New Jersey, USA.
Hanley MJ; Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Wang S; Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Zhang P; Takeda Development Center Americas, Inc., Lexington, Massachusetts, USA.
Venkatakrishnan K; Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, Massachusetts, USA.
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Źródło:
Clinical and translational science [Clin Transl Sci] 2022 May; Vol. 15 (5), pp. 1143-1154. Date of Electronic Publication: 2022 Feb 08.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Carcinoma, Non-Small-Cell Lung*/drug therapy
Lung Neoplasms*/drug therapy
Lung Neoplasms*/pathology
Anaplastic Lymphoma Kinase ; Humans ; Organophosphorus Compounds ; Protein Kinase Inhibitors/adverse effects ; Pyrimidines/adverse effects
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Pharmacometric modeling and machine learning analyses of prognostic and predictive factors in the JAVELIN Gastric 100 phase III trial of avelumab.
Autorzy:
Terranova N; Merck Institute of Pharmacometrics (an affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.
French J; Metrum Research Group, Tariffville, Connecticut, USA.
Dai H; EMD Serono, Billerica, Massachusetts, USA.
Wiens M; Metrum Research Group, Tariffville, Connecticut, USA.
Khandelwal A; The healthcare business of Merck KGaA, Darmstadt, Germany.
Ruiz-Garcia A; Metrum Research Group, San Diego, California, USA.
Manitz J; EMD Serono, Billerica, Massachusetts, USA.
von Heydebreck A; The healthcare business of Merck KGaA, Darmstadt, Germany.
Ruisi M; EMD Serono, Billerica, Massachusetts, USA.
Chin K; EMD Serono, Billerica, Massachusetts, USA.
Girard P; Merck Institute of Pharmacometrics (an affiliate of Merck KGaA, Darmstadt, Germany), Lausanne, Switzerland.
Venkatakrishnan K; EMD Serono, Billerica, Massachusetts, USA.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2022 Mar; Vol. 11 (3), pp. 333-347. Date of Electronic Publication: 2022 Jan 19.
Typ publikacji:
Clinical Trial, Phase III; Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal, Humanized*
Stomach Neoplasms*/drug therapy
Humans ; Machine Learning ; Prognosis
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Model-informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets.
Autorzy:
Munafo A; Merck Institute for Pharmacometrics, Merck Serono S.A., Lausanne, Switzerland.; An Affiliate of Merck KGaA, Darmstadt, Germany.
Terranova N; Merck Institute for Pharmacometrics, Merck Serono S.A., Lausanne, Switzerland.; An Affiliate of Merck KGaA, Darmstadt, Germany.
Li D; An Affiliate of Merck KGaA, Darmstadt, Germany.; Merck Serono Pharmaceutical R&D Co. Ltd. China, Beijing, China.
Liu P; Clinical Pharmacology, Linking Truth Technology Co., Ltd., Beijing, China.
Venkatakrishnan K; An Affiliate of Merck KGaA, Darmstadt, Germany.; EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts, USA.
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Źródło:
Clinical and translational science [Clin Transl Sci] 2022 Feb; Vol. 15 (2), pp. 297-308. Date of Electronic Publication: 2021 Oct 26.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't; Review
MeSH Terms:
Dose-Response Relationship, Drug*
Cladribine/*administration & dosage
Asia/ethnology ; Biological Availability ; Cladribine/pharmacokinetics ; Drug Interactions/ethnology ; Humans ; Treatment Outcome
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Single-Dose Pharmacokinetics and Tolerability of the Oral Epidermal Growth Factor Receptor Inhibitor Mobocertinib (TAK-788) in Healthy Volunteers: Low-Fat Meal Effect and Relative Bioavailability of 2 Capsule Products.
Autorzy:
Zhang S; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Jin S; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Griffin C; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Feng Z; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Lin J; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Baratta M; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Brake R; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Venkatakrishnan K; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Gupta N; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Sep; Vol. 10 (9), pp. 1028-1043. Date of Electronic Publication: 2021 Jun 12.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Food-Drug Interactions*
Aniline Compounds/*administration & dosage
Indoles/*administration & dosage
Protein Kinase Inhibitors/*administration & dosage
Pyrimidines/*administration & dosage
Administration, Oral ; Adolescent ; Adult ; Aniline Compounds/adverse effects ; Aniline Compounds/pharmacokinetics ; Biological Availability ; Cohort Studies ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Half-Life ; Humans ; Indoles/adverse effects ; Indoles/pharmacokinetics ; Male ; Middle Aged ; Protein Kinase Inhibitors/adverse effects ; Protein Kinase Inhibitors/pharmacokinetics ; Pyrimidines/adverse effects ; Pyrimidines/pharmacokinetics ; Therapeutic Equivalency ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Effects of Itraconazole and Rifampin on the Pharmacokinetics of Mobocertinib (TAK-788), an Oral Epidermal Growth Factor Receptor Inhibitor, in Healthy Volunteers.
Autorzy:
Zhang S; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Jin S; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Griffin C; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Feng Z; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Lin J; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
Venkatakrishnan K; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.; EMD Serono, Inc., Billerica, Massachusetts, USA.
Gupta N; Millennium Pharmaceuticals, Inc., Cambridge, Massachusetts, USA, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Sep; Vol. 10 (9), pp. 1044-1053. Date of Electronic Publication: 2021 Jun 19.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Aniline Compounds/*pharmacokinetics
Cytochrome P-450 CYP3A Inducers/*pharmacology
Cytochrome P-450 CYP3A Inhibitors/*pharmacology
Indoles/*pharmacokinetics
Pyrimidines/*pharmacokinetics
Administration, Oral ; Adult ; Area Under Curve ; Drug Interactions ; Female ; Humans ; Itraconazole/pharmacology ; Male ; Middle Aged ; Protein Kinase Inhibitors/pharmacokinetics ; Rifampin/pharmacology
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Asia-inclusive global development of pevonedistat: Clinical pharmacology and translational research enabling a phase 3 multiregional clinical trial.
Autorzy:
Zhou X; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Friedlander S; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Kupperman E; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Sedarati F; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Kuroda S; Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Hua Z; Alnylam Pharmaceuticals Inc., Cambridge, MA, USA.
Yuan Y; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Yamamoto Y; Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Faller DV; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Haikawa K; Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Nakai K; Takeda Pharmaceutical Company Limited, Tokyo, Japan.
Bowen S; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
Dai Y; Takeda Pharmaceutical Company Limited, Beijing, China.
Venkatakrishnan K; Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.
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Źródło:
Clinical and translational science [Clin Transl Sci] 2021 May; Vol. 14 (3), pp. 1069-1081. Date of Electronic Publication: 2021 Feb 02.
Typ publikacji:
Clinical Trial, Phase III; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
MeSH Terms:
Antineoplastic Combined Chemotherapy Protocols/*pharmacology
Cyclopentanes/*pharmacology
Drugs, Investigational/*pharmacology
Pharmacology, Clinical/*organization & administration
Pyrimidines/*pharmacology
Translational Research, Biomedical/*organization & administration
Antineoplastic Combined Chemotherapy Protocols/therapeutic use ; Asia/epidemiology ; Azacitidine/pharmacology ; Azacitidine/therapeutic use ; Cyclopentanes/therapeutic use ; Drugs, Investigational/therapeutic use ; Global Burden of Disease ; Humans ; Incidence ; International Cooperation ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/epidemiology ; Leukemia, Myelomonocytic, Chronic/drug therapy ; Leukemia, Myelomonocytic, Chronic/epidemiology ; Maximum Tolerated Dose ; Myelodysplastic Syndromes/drug therapy ; Myelodysplastic Syndromes/epidemiology ; Pyrimidines/therapeutic use ; Ubiquitin-Activating Enzymes/antagonists & inhibitors ; United States/epidemiology
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
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