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المؤلفون: Kathrin Möllenhoff, Florence Loingeville, Julie Bertrand, Thu Thuy Nguyen, Satish Sharan, Liang Zhao, Lanyan Fang, Guoying Sun, Stella Grosser, France Mentré, Holger Dette
المساهمون: Industrial Engineering and Innovation Sciences
المصدر: Biostatistics, 23(1), 314-327. Oxford University Press
مصطلحات موضوعية: Statistics and Probability, FOS: Computer and information sciences, High variability, Type (model theory), Bioequivalence, 030226 pharmacology & pharmacy, 01 natural sciences, Food and drug administration, Methodology (stat.ME), 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, Humans, Applied mathematics, Computer Simulation, 0101 mathematics, Statistics - Methodology, Mathematics, bioequivalence, Cross-Over Studies, two one-sided tests, General Medicine, PK Parameters, Confidence interval, Nonlinear Dynamics, Therapeutic Equivalency, Area Under Curve, nonlinear mixed effects model, Mixed effects, Statistics, Probability and Uncertainty, Geometric mean, noncompartmental bioequivalence analysis, pharmacokinetics
وصف الملف: application/pdf
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ae0be8113451e5ec3f4bd0893cf3b580Test
https://doi.org/10.1093/biostatistics/kxaa026Test -
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المؤلفون: Satish, Sharan, Sungwoo, Choi, Yuan, Zou, Yan, Wang, Myong-Jin, Kim, Lanyan, Fang, Stephanie, Choi, Fairouz, Makhlouf, Stella C, Grosser, Xinyuan, Zhang, Liang, Zhao
المصدر: The AAPS Journal. 24
مصطلحات موضوعية: Time Factors, Therapeutic Equivalency, Contraceptive Agents, Female, Intrauterine Devices, Medicated, Humans, Pharmaceutical Science, Female, Levonorgestrel
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::dd829424cce0700986bdb411365ee7deTest
https://doi.org/10.1208/s12248-022-00715-zTest -
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المؤلفون: Hao Zhu, Robert Lionberger, Mingjiang Xu, Bing Li, Nilufer Tampal, Satish Sharan, Liang Zhao, Lanyan Fang, Lei Zhang, Ramana S. Uppoor
المصدر: Clinical Pharmacology & Therapeutics. 110:880-887
مصطلحات موضوعية: Drug, media_common.quotation_subject, Cmax, Biological Availability, Abuse-Deterrent Formulations, Bioequivalence, 030226 pharmacology & pharmacy, 03 medical and health sciences, 0302 clinical medicine, Pharmacokinetics, Generic drug, Humans, Medicine, Pharmacology (medical), media_common, Pharmacology, Actuarial science, United States Food and Drug Administration, business.industry, Area under the curve, United States, Bioavailability, Therapeutic Equivalency, Area Under Curve, Delayed-Action Preparations, 030220 oncology & carcinogenesis, Drug and Narcotic Control, Metric (unit), business
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::da3bc0f15083d0a135e74924bf7fd1a8Test
https://doi.org/10.1002/cpt.2174Test -
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المؤلفون: Evangelos Kotzagiorgis, Shinichi Kijima, Om Anand, Yang Zhao, Sandra Suarez-Sharp, Talia Flanagan, Min Li, Baoming Ning, Poonam Delvadia, Shefali Kakar, Amitava Mitra, Greg Rullo, Jennifer B. Dressman, Neil Parrott, Erik Sjögren, Banu S. Zolnik, Shereeni Veerasingham, Paul A. Dickinson, Gustavo Mendes Lima Santos, Tycho Heimbach, Haritha Mandula, Christophe Tistaert, Fang Wu, Kimberly Raines, Satish Sharan, Xavier Pepin, Andrew Babiskin
المصدر: Journal of Pharmaceutical Sciences. 110:594-609
مصطلحات موضوعية: Research Report, Process management, Computer science, media_common.quotation_subject, Pharmaceutical Science, Harmonization, 02 engineering and technology, Models, Biological, 030226 pharmacology & pharmacy, Biopharmaceutics, 03 medical and health sciences, 0302 clinical medicine, Humans, Quality (business), Pharmaceutical industry, media_common, business.industry, 021001 nanoscience & nanotechnology, Clinical formulation, Pharmaceutical Preparations, Solubility, New product development, Drug product, Regulatory agency, 0210 nano-technology, business
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fd0af49b3fa2be786e937037a5062f10Test
https://doi.org/10.1016/j.xphs.2020.10.059Test -
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المؤلفون: Mélanie Guhl, François Mercier, Carsten Hofmann, Satish Sharan, Mark Donnelly, Kairui Feng, Wanjie Sun, Guoying Sun, Stella Grosser, Liang Zhao, Lanyan Fang, France Mentré, Emmanuelle Comets, Julie Bertrand
المساهمون: Université Paris Cité (UPCité), Infection, Anti-microbiens, Modélisation, Evolution (IAME (UMR_S_1137 / U1137)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité)-Université Sorbonne Paris Nord, F. Hoffmann-La Roche [Basel], U.S. Food and Drug Administration (FDA), Université Sorbonne Paris Nord, Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), U.S. Food and Drug Administration (FDA) [75F40119C1011], FDA
المصدر: Journal of Pharmacokinetics and Pharmacodynamics
Journal of Pharmacokinetics and Pharmacodynamics, 2022, 49, pp.557-577. ⟨10.1007/s10928-022-09821-z⟩مصطلحات موضوعية: Pharmacology, Equivalence test, Non-compartmental analysis, Non-linear mixed effects models, [SDV]Life Sciences [q-bio], Sparse design, Antibodies, Monoclonal, Pharmacokinetics, Computer Simulation, [SDV.SP]Life Sciences [q-bio]/Pharmaceutical sciences
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::def5fc6fa579f4d05561a2465be8ae85Test
https://pubmed.ncbi.nlm.nih.gov/36112338Test -
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المؤلفون: Lanyan Fang, Satish Sharan, Viera Lukacova, Xiaomei Chen, Mats O. Karlsson, Andrew C. Hooker
مصطلحات موضوعية: medicine.medical_specialty, Physiologically based pharmacokinetic modelling, PBPK, Injections, Subcutaneous, Pharmaceutical Science, Model-Informed Drug Development, Quantitative Clinical Pharmacology, Pharmacology and Toxicology, Bioequivalence, Drug Prescriptions, Injections, Intramuscular, Injections, Medication Adherence, law.invention, Drug Development, MIDD, law, Generic drug, Paliperidone Palmitate, medicine, Humans, Pharmacokinetics, Pharmacology (medical), Medical physics, Clinical pharmacology, Dose-Response Relationship, Drug, business.industry, Long Acting Injectable, Models, Theoretical, Farmakologi och toxikologi, United States, LAI, QCP, Long acting, Therapeutic Equivalency, Drug development, Generic Drug, Modeling and Simulation, Pharmacology, Clinical, Schizophrenia, Safety, business, Antipsychotic Agents
وصف الملف: application/pdf
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6547d84969123761ad8bf5b0d338bf19Test
http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-438799Test -
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المؤلفون: Abhishek Trivedi, Amandeep Kumar, Prema Satish Sharan, Aaron Augustine, Ravi Kiran Sarvadevabhatla, Sowmya Aitha
المصدر: Document Analysis and Recognition – ICDAR 2021 ISBN: 9783030863302
ICDAR (2)مصطلحات موضوعية: Arabic, Computer science, business.industry, Generalization, computer.software_genre, language.human_language, Domain (software engineering), Hausdorff distance, ComputingMethodologies_DOCUMENTANDTEXTPROCESSING, language, Segmentation, Artificial intelligence, business, computer, Natural language processing
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_________::91d6728e38dfbbc59ec4e7d16de3ec9bTest
https://doi.org/10.1007/978-3-030-86331-9_31Test -
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المؤلفون: Mark Donnelly, Thomas Straubinger, Liang Zhao, Satish Sharan, Robert R. Bies, Eleftheria Tsakalozou
المصدر: The Journal of Clinical Pharmacology. 60
مصطلحات موضوعية: Pharmacology, United States Food and Drug Administration, business.industry, Pharmacokinetic modeling, Genitalia, Female, Bioequivalence, Models, Biological, United States, Drug Development, Therapeutic Equivalency, Risk analysis (engineering), Generic drug, Drugs, Generic, Humans, Medicine, Female, Pharmacology (medical), business, Female Reproductive Tract
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::fc6165721f24e77fa24cbcd55e3b20b5Test
https://doi.org/10.1002/jcph.1760Test -
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المؤلفون: Liang Zhao, Lanyan Fang, Yuan Zou, Yan Wang, Mark Donnelly, Myong-Jin Kim, Satish Sharan
المصدر: The Journal of Clinical Pharmacology. 60
مصطلحات موضوعية: Pharmacology, Economic growth, business.industry, Health Services Accessibility, United States, Therapeutic Equivalency, Contraceptive Agents, Female, Device Approval, Drugs, Generic, Humans, Medicine, Female, Pharmacology (medical), Regulatory science, Progesterones, business, Intrauterine Devices
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::c7230cbdf9f23eebec1213afd6edf044Test
https://doi.org/10.1002/jcph.1710Test -
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المؤلفون: Sukyung Woo, Deborah Wright, Won S. Yang, Andrew J. Cohoon, Randy L. Jensen, Eun Ha Kim, April M. Teague, Rheal A. Towner, Yan Zhao, Alexandra Ikeguchi, Sarah Sung, Satish Sharan, James Battiste
المصدر: Neuro Oncol
مصطلحات موضوعية: Prothrombin time, Oncology, Cancer Research, medicine.medical_specialty, medicine.diagnostic_test, business.industry, Clinical Trials: Non-Immunologic, medicine.disease, Clinical trial, Glioma, Maximum tolerated dose, Internal medicine, Troponin I, medicine, Neurology (clinical), business, Adverse effect, Glioblastoma
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::eb2818179f117523f3f42cd74ae7f92cTest
https://europepmc.org/articles/PMC7650506Test/
