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Wyszukujesz frazę ""Injections, Subcutaneous"" wg kryterium: Temat

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Tytuł:
Pharmacokinetics of Subcutaneous Dupilumab Injection With an Autoinjector Device or Prefilled Syringe.
Autorzy:
Cohen YZ; Sanofi, Bridgewater, New Jersey, USA.
Zhang X; Sanofi, Beijing, China.
Xia B; Sanofi, Bridgewater, New Jersey, USA.
Kosloski MP; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Kamal MA; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Davis JD; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Kanamaluru V; Sanofi, Bridgewater, New Jersey, USA.
Xu C; Sanofi, Bridgewater, New Jersey, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2022 May; Vol. 11 (5), pp. 675-681. Date of Electronic Publication: 2022 Mar 12.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal, Humanized*/pharmacokinetics
Syringes*
Adult ; Child ; Female ; Humans ; Injections, Subcutaneous ; Male ; Therapeutic Equivalency
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Carbol fuchsin stain enhances detection of poly-(d, l-lactide-co-glycolide) microspheres in exenatide extended-release cutaneous injection-site foreign body reaction.
Autorzy:
Flugrad R; Department of Pathology and Laboratory Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Hoerres D; Department of Pathology and Laboratory Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
Googe PB; Department of Pathology and Laboratory Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.; Department of Dermatology, UNC Dermatopathology Laboratory, School of Medicine, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.
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Źródło:
Journal of cutaneous pathology [J Cutan Pathol] 2021 Dec; Vol. 48 (12), pp. 1520-1522. Date of Electronic Publication: 2021 Aug 12.
Typ publikacji:
Case Reports
MeSH Terms:
Coloring Agents*
Rosaniline Dyes*
Delayed-Action Preparations/*adverse effects
Foreign-Body Reaction/*diagnosis
Polylactic Acid-Polyglycolic Acid Copolymer/*adverse effects
Diabetes Mellitus, Type 2/drug therapy ; Drug Carriers/adverse effects ; Exenatide/administration & dosage ; Female ; Foreign-Body Reaction/chemically induced ; Granuloma/chemically induced ; Granuloma/diagnosis ; Humans ; Hypoglycemic Agents/administration & dosage ; Injections, Subcutaneous ; Microspheres ; Middle Aged
Raport
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Randomized, Open-Label, Single-Dose, Parallel-Group Pharmacokinetic Study of PF-06410293 (adalimumab-afzb), an Adalimumab Biosimilar, by Subcutaneous Dosing Using a Prefilled Syringe or a Prefilled Pen in Healthy Subjects.
Autorzy:
Cox DS; Pfizer Inc, Collegeville, Pennsylvania, USA.
Alvarez DF; Pfizer Inc, Collegeville, Pennsylvania, USA.
Bock AE; Pfizer Inc, Cambridge, Massachusetts, USA.
Cronenberger CL; Pfizer Inc, Collegeville, Pennsylvania, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Oct; Vol. 10 (10), pp. 1166-1173. Date of Electronic Publication: 2021 Mar 25.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Syringes*
Adalimumab/*administration & dosage
Adalimumab/*blood
Biosimilar Pharmaceuticals/*administration & dosage
Biosimilar Pharmaceuticals/*blood
Adalimumab/adverse effects ; Adult ; Biosimilar Pharmaceuticals/adverse effects ; Female ; Healthy Volunteers ; Humans ; Injection Site Reaction/diagnosis ; Injections, Subcutaneous/methods ; Male ; Middle Aged
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Grade II-anaphylaxis after subcutaneous injection of mistletoe extract.
Autorzy:
Casetti F; Department of Dermatology and Allergology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Rafei-Shamsabadi D; Department of Dermatology and Allergology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Müller S; Department of Dermatology and Allergology, Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
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Źródło:
Contact dermatitis [Contact Dermatitis] 2021 Oct; Vol. 85 (4), pp. 462-465. Date of Electronic Publication: 2021 Jun 30.
Typ publikacji:
Case Reports; Journal Article
MeSH Terms:
Anaphylaxis/*chemically induced
Mistletoe/*adverse effects
Plant Extracts/*adverse effects
Adult ; Anaphylaxis/classification ; Female ; Humans ; Injections, Subcutaneous ; Plant Extracts/administration & dosage ; Urticaria/chemically induced
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Results of a Dose-Finding Phase 1b Study of Subcutaneous Atezolizumab in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer.
Autorzy:
Felip E; Vall d'Hebron University Hospital and Institute of Oncology (VHIO), UVic-UCC, IOB-Quiron, Barcelona, Spain.
Burotto M; Centro de Investigación Clínica Bradford Hill, Santiago, Chile.
Zvirbule Z; Riga Eastern Clinical University Hospital, Riga, Latvia.
Herraez-Baranda LA; F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
Chanu P; Genentech/Roche, Lyon, France.
Kshirsagar S; Genentech, Inc., South San Francisco, California, USA.
Maiya V; Genentech, Inc., South San Francisco, California, USA.
Chan P; Genentech, Inc., South San Francisco, California, USA.
Pozzi E; F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
Marchand M; Certara Strategic Consulting, Paris, France.
Monchalin M; F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
Tanaka K; Genentech, Inc., South San Francisco, California, USA.
Tosti N; F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
Wang B; Genentech, Inc., South San Francisco, California, USA.
Restuccia E; F. Hoffmann-La Roche, Ltd., Basel, Switzerland.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Oct; Vol. 10 (10), pp. 1142-1155. Date of Electronic Publication: 2021 Mar 31.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal, Humanized/*administration & dosage
Antineoplastic Agents/*administration & dosage
Carcinoma, Non-Small-Cell Lung/*drug therapy
Lung Neoplasms/*drug therapy
Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/blood ; Antineoplastic Agents/blood ; Carcinoma, Non-Small-Cell Lung/blood ; Carcinoma, Non-Small-Cell Lung/diagnosis ; Dose-Response Relationship, Drug ; Female ; Humans ; Injections, Subcutaneous ; Lung Neoplasms/diagnosis ; Lung Neoplasms/epidemiology ; Male ; Middle Aged
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
A Pharmacokinetic Bioequivalence Study of Fremanezumab Administered Subcutaneously Using an Autoinjector and a Prefilled Syringe.
Autorzy:
Cherniakov I; Specialty Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel.
Cohen-Barak O; Specialty Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel.
Tiver R; Specialty Clinical Development Teva Branded Pharmaceutical Products R&D, West Chester, Pennsylvania, USA.
Gillespie M; Specialty Clinical Development Teva Branded Pharmaceutical Products R&D, West Chester, Pennsylvania, USA.
Kessler Y; Specialty Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel.
Gutierrez M; Teva Internal Clinics US, Miramar, Florida, USA.
Rasamoelisolo M; Nonclinical Development Teva Pharmaceutical Industries Ltd, West Chester, Pennsylvania, USA.
Li S; Nonclinical Development Teva Pharmaceutical Industries Ltd, West Chester, Pennsylvania, USA.
Shen H; Nonclinical Development Teva Pharmaceutical Industries Ltd, West Chester, Pennsylvania, USA.
Hallak H; Specialty Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel.
Loupe PS; Nonclinical Development Teva Pharmaceutical Industries Ltd, West Chester, Pennsylvania, USA.
Smith M; Device R&D, Teva Pharmaceutical Industries Ltd, Runcorn, United Kingdom.
Rabinovich-Guilatt L; Specialty Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel.
Spiegelstein O; Specialty Clinical Development, Teva Pharmaceutical Industries Ltd, Netanya, Israel.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Sep; Vol. 10 (9), pp. 1018-1027. Date of Electronic Publication: 2021 Jan 07.
Typ publikacji:
Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal/*administration & dosage
Calcitonin Gene-Related Peptide/*immunology
Adolescent ; Adult ; Antibodies, Monoclonal/adverse effects ; Antibodies, Monoclonal/pharmacokinetics ; Area Under Curve ; Equipment Design ; Female ; Half-Life ; Humans ; Injections, Subcutaneous ; Male ; Middle Aged ; Therapeutic Equivalency ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Evaluation of Drug-Drug Interaction Liability for Buprenorphine Extended-Release Monthly Injection Administered by Subcutaneous Route.
Autorzy:
Kharidia J; Indivior Inc., North Chesterfield, Virginia, USA.
Howgate EM; Certara UK Limited (Simcyp Division), Sheffield, UK.
Laffont CM; Indivior Inc., North Chesterfield, Virginia, USA.
Liu Y; Indivior Inc., North Chesterfield, Virginia, USA.
Young MA; Indivior Inc., North Chesterfield, Virginia, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Sep; Vol. 10 (9), pp. 1064-1074. Date of Electronic Publication: 2021 Mar 22.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Models, Biological*
Buprenorphine/*pharmacokinetics
Cytochrome P-450 CYP3A Inducers/*pharmacology
Cytochrome P-450 CYP3A Inhibitors/*pharmacology
Adult ; Area Under Curve ; Buprenorphine/administration & dosage ; Delayed-Action Preparations ; Drug Interactions ; Female ; Humans ; Injections, Subcutaneous ; Male ; Middle Aged ; Narcotic Antagonists/administration & dosage ; Narcotic Antagonists/pharmacokinetics ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Pharmacometric analysis linking immunoglobulin exposure to clinical efficacy outcomes in chronic inflammatory demyelinating polyneuropathy.
Autorzy:
Tortorici MA; CSL Behring, King of Prussia, Pennsylvania, USA.
Yuraszeck T; CSL Behring, King of Prussia, Pennsylvania, USA.
Cornblath D; Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Bril V; Ellen and Martin Prosserman Centre for Neuromuscular Diseases, Division of Neurology, Department of Medicine, University Health Network, University of Toronto, Toronto, Canada.; Institute for Research and Medical Consultations, Imam Abdulrahman Bin Faisal University, Dammam, Saudi Arabia.
Hartung HP; Department of Neurology, UKD and Center for Neurology and Neuropsychiatry, LVR Klinikum, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.; Brain and Mind Centre, University of Sydney, Sydney, Australia.; Medical University of Vienna, Vienna, Austria.
Sobue G; Department of Neurology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Lewis RA; Department of Neurology, Cedars-Sinai Medical Center, Los Angeles, California, USA.
Merkies ISJ; Department of Neurology, Maastricht University Medical Center, Maastricht, The Netherlands.; Curaçao Medical Center, Willemstad, Curaçao.
Lawo JP; CSL Behring, Marburg, Germany.
Praus M; CSL Behring, Marburg, Germany.
Durn BL; CSL Behring, King of Prussia, Pennsylvania, USA.
Mielke O; CSL Behring, Marburg, Germany.
Ma X; CSL Behring, King of Prussia, Pennsylvania, USA.
Jauslin P; Certara, Princeton, New Jersey, USA.
Pfister M; University of Basel, Basel, Switzerland.
van Schaik IN; Department of Neurology, Amsterdam University Medical Centres, University of Amsterdam, Amsterdam, The Netherlands.; Spaarne Gasthuis, Haarlem, The Netherlands.
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Corporate Authors:
PATH study group
Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2021 Aug; Vol. 10 (8), pp. 839-850. Date of Electronic Publication: 2021 Aug 01.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Models, Biological*
Immunoglobulin G/*administration & dosage
Immunologic Factors/*administration & dosage
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating/*drug therapy
Adult ; Aged ; Aged, 80 and over ; Drug Administration Schedule ; Female ; Humans ; Immunoglobulin G/metabolism ; Immunologic Factors/pharmacokinetics ; Injections, Subcutaneous ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; Treatment Outcome ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Population pharmacokinetic and exposure-response analyses of intravenous and subcutaneous rituximab in patients with chronic lymphocytic leukemia.
Autorzy:
Gibiansky E; QuantPharm LLC, North Potomac, Maryland, USA.
Gibiansky L; QuantPharm LLC, North Potomac, Maryland, USA.
Chavanne C; Roche Innovation Center Basel, Basel, Switzerland.
Frey N; Roche Innovation Center Basel, Basel, Switzerland.
Jamois C; Roche Innovation Center Basel, Basel, Switzerland.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2021 Aug; Vol. 10 (8), pp. 914-927. Date of Electronic Publication: 2021 Jul 16.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Models, Biological*
Antineoplastic Agents, Immunological/*pharmacokinetics
Leukemia, Lymphocytic, Chronic, B-Cell/*drug therapy
Rituximab/*pharmacokinetics
Administration, Intravenous ; Adult ; Aged ; Antineoplastic Agents, Immunological/administration & dosage ; Antineoplastic Agents, Immunological/adverse effects ; Female ; Humans ; Injections, Subcutaneous ; Male ; Middle Aged ; Randomized Controlled Trials as Topic ; Rituximab/administration & dosage ; Rituximab/adverse effects ; Time Factors
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Population pharmacokinetic analysis of dupilumab in adult and adolescent patients with asthma.
Autorzy:
Zhang L; Sanofi, Bridgewater, New Jersey, USA.
Gao Y; Sanofi, Bridgewater, New Jersey, USA.
Li M; Sanofi, Bridgewater, New Jersey, USA.
Xu C; Sanofi, Bridgewater, New Jersey, USA.
Davis JD; Regeneron Pharmaceuticals, Inc., Tarrytown, New York, USA.
Kanamaluru V; Sanofi, Bridgewater, New Jersey, USA.
Lu Q; Sanofi, Bridgewater, New Jersey, USA.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2021 Aug; Vol. 10 (8), pp. 941-952. Date of Electronic Publication: 2021 Jul 27.
Typ publikacji:
Journal Article; Meta-Analysis; Research Support, Non-U.S. Gov't
MeSH Terms:
Models, Biological*
Antibodies, Monoclonal, Humanized/*pharmacokinetics
Asthma/*drug therapy
Administration, Intravenous ; Adolescent ; Adult ; Aged ; Aged, 80 and over ; Antibodies, Monoclonal, Humanized/administration & dosage ; Asthma/physiopathology ; Biological Availability ; Case-Control Studies ; Child ; Clinical Trials, Phase I as Topic ; Clinical Trials, Phase III as Topic ; Dermatitis, Atopic/drug therapy ; Female ; Humans ; Injections, Subcutaneous ; Male ; Middle Aged ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Safety, Pharmacokinetics, and Neutralizing Activity of SYN023, a Mixture of Two Novel Antirabies Monoclonal Antibodies Intended for Use in Postrabies Exposure Prophylaxis.
Autorzy:
McClain JB; Synermore Biologics Co. Ltd, Taipei City, Taiwan.
Chuang A; Synermore Biologics Co. Ltd, Taipei City, Taiwan.
Moore SM; Rabies Laboratory, Kansas State Veterinary Diagnostic Laboratory, Kansas State University, Manhattan, Kansas, USA.
Tsao E; Synermore Biologics Co. Ltd, Taipei City, Taiwan.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Jul; Vol. 10 (7), pp. 807-817. Date of Electronic Publication: 2021 Jan 25.
Typ publikacji:
Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal, Humanized/*administration & dosage
Antibodies, Neutralizing/*immunology
Adult ; Antibodies, Monoclonal, Humanized/immunology ; Antibodies, Monoclonal, Humanized/pharmacokinetics ; Dose-Response Relationship, Drug ; Female ; Humans ; Injections, Intramuscular ; Injections, Subcutaneous ; Male ; Middle Aged ; Post-Exposure Prophylaxis/methods ; Rabies/prevention & control ; Time Factors ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Relationship of the Calcitonin Gene-Related Peptide Monoclonal Antibody Galcanezumab Pharmacokinetics and Capsaicin-Induced Dermal Blood Flow in Healthy Subjects.
Autorzy:
Fiedler-Kelly J; Cognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
Raddad E; Eli Lilly and Company, Indianapolis, Indiana, USA.
de Hoon J; Center for Clinical Pharmacology, Department of Pharmaceutical and Pharmacological Sciences, KU Leuven and University Hospitals Leuven, Leuven, Belgium.
Ludwig EA; Cognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
Passarell J; Cognigen Corporation, a Simulations Plus company, Buffalo, New York, USA.
Kielbasa W; Eli Lilly and Company, Indianapolis, Indiana, USA.
Collins EC; Eli Lilly and Company, Indianapolis, Indiana, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 May; Vol. 10 (5), pp. 440-452. Date of Electronic Publication: 2021 Mar 19.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Models, Biological*
Antibodies, Monoclonal, Humanized/*administration & dosage
Calcitonin Gene-Related Peptide/*antagonists & inhibitors
Capsaicin/*pharmacology
Adolescent ; Adult ; Antibodies, Monoclonal, Humanized/pharmacokinetics ; Antibodies, Monoclonal, Humanized/pharmacology ; Cohort Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Half-Life ; Humans ; Inhibitory Concentration 50 ; Injections, Subcutaneous ; Male ; Middle Aged ; Tissue Distribution ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknieSzczegóły
Tytuł:
Biosimilarity Assessment of 2 Filgrastim Therapeutics in Healthy Volunteers.
Autorzy:
Khandoozi SR; Department of Oncology, 5 Azar Hospital, Golestan University of Medical Sciences, Gorgan, Iran.
Shahbazi M; Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran.; AryaTinaGene Biopharmaceutical Company, Gorgan, Iran.
Amini H; Medical Cellular and Molecular Research Center, Golestan University of Medical Sciences, Gorgan, Iran.; AryaTinaGene Biopharmaceutical Company, Gorgan, Iran.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Apr; Vol. 10 (4), pp. 346-352. Date of Electronic Publication: 2020 Aug 21.
Typ publikacji:
Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Biosimilar Pharmaceuticals/*administration & dosage
Filgrastim/*administration & dosage
Hematologic Agents/*administration & dosage
Adult ; Area Under Curve ; Biosimilar Pharmaceuticals/pharmacokinetics ; Biosimilar Pharmaceuticals/pharmacology ; Cross-Over Studies ; Filgrastim/pharmacokinetics ; Filgrastim/pharmacology ; Half-Life ; Hematologic Agents/pharmacokinetics ; Hematologic Agents/pharmacology ; Humans ; Injections, Subcutaneous ; Male ; Neutrophils/cytology ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Model-Informed Drug Development for Long-Acting Injectable Products: Summary of American College of Clinical Pharmacology Symposium.
Autorzy:
Sharan S; Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Fang L; Division of Quantitative Methods and Modeling (DQMM), Office of Research and Standards (ORS), Office of Generic Drugs (OGD), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
Lukacova V; Simulation Sciences, Simulations Plus, Inc., Lancaster, CA, USA.
Chen X; Uppsala University, Uppsala, Sweden.
Hooker AC; Uppsala University, Uppsala, Sweden.
Karlsson MO; Uppsala University, Uppsala, Sweden.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Mar; Vol. 10 (3), pp. 220-228. Date of Electronic Publication: 2021 Feb 23.
Typ publikacji:
Journal Article; Research Support, U.S. Gov't, P.H.S.
MeSH Terms:
Drug Development/*methods
Drug Prescriptions/*statistics & numerical data
Injections/*statistics & numerical data
Pharmacology, Clinical/*organization & administration
Antipsychotic Agents/administration & dosage ; Antipsychotic Agents/pharmacokinetics ; Dose-Response Relationship, Drug ; Humans ; Injections, Intramuscular/methods ; Injections, Subcutaneous/methods ; Medication Adherence/statistics & numerical data ; Models, Theoretical ; Paliperidone Palmitate/administration & dosage ; Paliperidone Palmitate/pharmacokinetics ; Pharmacokinetics ; Safety ; Schizophrenia/drug therapy ; Therapeutic Equivalency ; United States
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
A Randomized, Double-Blind, Parallel-Group, Phase 1 Clinical Trial Comparing the Pharmacokinetic, Safety, and Immunogenicity of the Biosimilar HS016 and the Originator Adalimumab in Chinese Healthy Male Subjects.
Autorzy:
Cao G; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
Yu J; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
Wu J; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
Wang J; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
Xue Y; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
Yang X; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
Zhang J; Phase I Clinical Trial Center, Huashan Hospital, Fudan University, Shanghai, China.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Mar; Vol. 10 (3), pp. 317-325. Date of Electronic Publication: 2020 May 28.
Typ publikacji:
Clinical Trial, Phase I; Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Adalimumab/*pharmacokinetics
Biosimilar Pharmaceuticals/*pharmacokinetics
Spondylitis, Ankylosing/*drug therapy
Tumor Necrosis Factor Inhibitors/*pharmacokinetics
Adalimumab/administration & dosage ; Adalimumab/adverse effects ; Adult ; Area Under Curve ; Biosimilar Pharmaceuticals/administration & dosage ; Biosimilar Pharmaceuticals/adverse effects ; China/epidemiology ; Double-Blind Method ; Healthy Volunteers/statistics & numerical data ; Humans ; Immunity/drug effects ; Injections, Subcutaneous ; Kinetics ; Male ; Safety ; Therapeutic Equivalency ; Tumor Necrosis Factor Inhibitors/administration & dosage ; Tumor Necrosis Factor Inhibitors/adverse effects
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Safety, Tolerability, and Pharmacokinetics of PF-06823859, an Anti-Interferon β Monoclonal Antibody: A Randomized, Phase I, Single- and Multiple-Ascending-Dose Study.
Autorzy:
Neelakantan S; Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.
Oemar B; Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.
Johnson K; Center for Therapeutic Innovation, Pfizer Inc, New York, New York, USA.
Rath N; Pfizer Inc, Collegeville, Pennsylvania, USA.
Salganik M; Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.
Berman G; Pfizer Inc, San Diego, California, USA.
Pelletier K; Pfizer Inc, Groton, Connecticut, USA.
Cox L; Pfizer Inc, Collegeville, Pennsylvania, USA.
Page K; Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.
Messing D; Worldwide Research and Development, Pfizer Inc, Cambridge, Massachusetts, USA.
Tarabar S; Pfizer Clinical Research Unit, New Haven, Connecticut, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Mar; Vol. 10 (3), pp. 307-316. Date of Electronic Publication: 2020 Dec 22.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal/*pharmacokinetics
Autoimmune Diseases/*drug therapy
Immunity/*drug effects
Interferon-beta/*antagonists & inhibitors
Administration, Intravenous ; Adult ; Antibodies, Monoclonal/administration & dosage ; Antibodies, Monoclonal/adverse effects ; Antibodies, Neutralizing/drug effects ; Autoimmune Diseases/immunology ; Biological Availability ; Case-Control Studies ; Double-Blind Method ; Drug Tolerance ; Female ; Half-Life ; Healthy Volunteers ; Humans ; Injections, Subcutaneous ; Interferon-beta/blood ; Interferon-beta/metabolism ; Male ; Middle Aged ; Pharmacokinetics ; Placebos/administration & dosage ; Safety
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Pharmacokinetics and Pharmacodynamics of Two Formulations of Pegylated Recombinant Human Granulocyte Colony-Stimulating Factor in Healthy Chinese Subjects: An Open-Label, Randomized, Parallel-Design Bioavailability Study.
Autorzy:
Hu C; Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Ji B; Department of Hematology, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.; Medical Affair Office, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Hu X; Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Yang C; Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Sun W; Department of Hematology, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Zhao X; Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Li L; Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Li X; Medical Affair Office, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
Zhang L; Department of Pharmacy, Phase I Clinical Trial Center, Xuanwu Hospital of Capital Medical University, National Clinical Research Center for Geriatric Diseases, Beijing, China.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Mar; Vol. 10 (3), pp. 291-298. Date of Electronic Publication: 2020 Jun 21.
Typ publikacji:
Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Drug Compounding/*methods
Febrile Neutropenia/*prevention & control
Granulocyte Colony-Stimulating Factor/*pharmacokinetics
Neutrophils/*drug effects
Polyethylene Glycols/*pharmacokinetics
Recombinant Proteins/*pharmacokinetics
Adult ; Area Under Curve ; Biological Availability ; China/epidemiology ; Drug Compounding/statistics & numerical data ; Enzyme-Linked Immunosorbent Assay/methods ; Filgrastim ; Granulocyte Colony-Stimulating Factor/administration & dosage ; Granulocyte Colony-Stimulating Factor/pharmacology ; Healthy Volunteers ; Humans ; Immunity/drug effects ; Injections, Subcutaneous ; Leukocyte Count/methods ; Male ; Middle Aged ; Neutrophils/cytology ; Polyethylene Glycols/administration & dosage ; Polyethylene Glycols/pharmacology ; Recombinant Proteins/administration & dosage ; Recombinant Proteins/pharmacology ; Safety
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Evaluation of the Pharmacokinetics, Pharmacodynamics, and Safety of a Single Dose of Emicizumab in Healthy Chinese Subjects.
Autorzy:
Li H; Drug Clinical Trial Center and the Department of Cardiology, Peking University, Third Hospital, Beijing, China.
Zhang W; F. Hoffmann-La Roche Ltd., New York, New York, USA.
Petry C; F. Hoffmann-La Roche AG, Basel, Switzerland.
Li L; F. Hoffmann-La Roche Ltd, Roche Product Development Shanghai, Shanghai, China.
Fernandez E; F. Hoffmann-La Roche AG, Basel, Switzerland.
Kiialainen A; F. Hoffmann-La Roche AG, Basel, Switzerland.
Feng S; F. Hoffmann-La Roche Ltd, pRED Roche Shanghai, China.
Hsu W; F. Hoffmann-La Roche Ltd, Roche Product Development Shanghai, Shanghai, China.
Li L; F. Hoffmann-La Roche Ltd, Roche Product Development Shanghai, Shanghai, China.
Wei Y; Drug Clinical Trial Center, Peking University, Third Hospital, Beijing, China.
Schmitt C; F. Hoffmann-La Roche AG, Basel, Switzerland.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2021 Jan; Vol. 10 (1), pp. 30-38. Date of Electronic Publication: 2020 May 20.
Typ publikacji:
Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Bispecific/*pharmacokinetics
Antibodies, Monoclonal, Humanized/*pharmacokinetics
Adult ; Antibodies/blood ; Antibodies, Bispecific/adverse effects ; Antibodies, Bispecific/blood ; Antibodies, Bispecific/pharmacology ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/blood ; Antibodies, Monoclonal, Humanized/pharmacology ; Asian People ; Factor VIII/analysis ; Healthy Volunteers ; Humans ; Injections, Subcutaneous ; Male ; White People ; Young Adult
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
Development of a Pharmacokinetic Model Describing Neonatal Fc Receptor-Mediated Recycling of HL2351, a Novel Hybrid Fc-Fused Interleukin-1 Receptor Antagonist, to Optimize Dosage Regimen.
Autorzy:
Ngo L; College of Pharmacy, Chungnam National University, Daejeon, Republic of Korea.
Oh J; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.
Kim A; Department of Clinical Pharmacology and Therapeutics, CHA Bundang Medical Center, CHA University, Seongnam, Gyeonggi-do, Republic of Korea.
Back HM; Department of Pharmaceutics, Ernest Mario School of Pharmacy, Rutgers, The State University of New Jersey, New Brunswick, New Jeresy, USA.
Kang WH; College of Pharmacy, Chungnam National University, Daejeon, Republic of Korea.
Chae JW; College of Pharmacy, Chungnam National University, Daejeon, Republic of Korea.
Yun HY; College of Pharmacy, Chungnam National University, Daejeon, Republic of Korea.
Lee H; Department of Clinical Pharmacology and Therapeutics, Seoul National University College of Medicine and Hospital, Seoul, Republic of Korea.; Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, Republic of Korea.
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Źródło:
CPT: pharmacometrics & systems pharmacology [CPT Pharmacometrics Syst Pharmacol] 2020 Oct; Vol. 9 (10), pp. 584-595. Date of Electronic Publication: 2020 Oct 06.
Typ publikacji:
Journal Article; Research Support, Non-U.S. Gov't
MeSH Terms:
Antirheumatic Agents/*pharmacokinetics
Histocompatibility Antigens Class I/*metabolism
Interleukin 1 Receptor Antagonist Protein/*pharmacokinetics
Receptors, Fc/*metabolism
Recombinant Proteins/*pharmacology
Adult ; Antibodies, Monoclonal/pharmacokinetics ; Antirheumatic Agents/administration & dosage ; Antirheumatic Agents/pharmacology ; Autoimmune Diseases/drug therapy ; Autoimmune Diseases/metabolism ; Biological Products ; Clinical Trials, Phase I as Topic ; Dose-Response Relationship, Drug ; Half-Life ; Humans ; Injections, Subcutaneous ; Interleukin 1 Receptor Antagonist Protein/administration & dosage ; Interleukin 1 Receptor Antagonist Protein/pharmacology ; Male ; Middle Aged ; Pharmacokinetics ; Republic of Korea/epidemiology
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Tytuł:
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Subcutaneous Tezepelumab in Healthy Japanese Men.
Autorzy:
Sakamoto K; AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.
Matsuki S; SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.
Irie S; SOUSEIKAI Fukuoka Mirai Hospital Clinical Research Center, Fukuoka, Japan.
Uchida N; Department of Pharmacology, Division of Clinical Pharmacology, Showa University School of Medicine, Tokyo, Japan.
Hayashi N; AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.
Horiuchi M; AstraZeneca K.K., Ofuka-cho, Kita-ku, Osaka, Japan.
Ren S; Quantitative Clinical Pharmacology, AstraZeneca, Gaithersburg, Maryland, USA.
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Źródło:
Clinical pharmacology in drug development [Clin Pharmacol Drug Dev] 2020 Oct; Vol. 9 (7), pp. 833-840. Date of Electronic Publication: 2020 Jan 20.
Typ publikacji:
Clinical Trial, Phase I; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't
MeSH Terms:
Antibodies, Monoclonal, Humanized/*pharmacokinetics
Asthma/*drug therapy
Cytokines/*antagonists & inhibitors
Immune System Phenomena/*drug effects
Immunoglobulin G/*pharmacology
Adult ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antibodies, Monoclonal, Humanized/immunology ; Asian People/ethnology ; Asthma/blood ; Asthma/immunology ; Body Mass Index ; Case-Control Studies ; Dose-Response Relationship, Drug ; Drug Administration Schedule ; Healthy Volunteers/statistics & numerical data ; Humans ; Immunoglobulin G/immunology ; Injections, Subcutaneous ; Male ; Placebo Effect ; Safety ; Severity of Illness Index ; Thymic Stromal Lymphopoietin
Czasopismo naukowe
Pełny tekst  Link otwiera się w nowym oknie Pełny tekstSzczegóły
Wyświetlanie 1-20 z 147

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