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1دورية أكاديمية
المؤلفون: Patel, Nishi, Prajapati, Hardik, Joshi, Navin, Movaliya, Vinit, Kanaki, Niranjan, Deshpande, Shrikalp, Zaveri, Maitreyi
المصدر: International Journal Of Drug Regulatory Affairs 12(1):70-82. 2024
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2دورية أكاديمية
المصدر: Orphanet Journal of Rare Diseases, Vol 19, Iss 1, Pp 1-12 (2024)
مصطلحات موضوعية: Biologic license application, New drug application, Orphan drugs, Rare diseases, Real-world data, Real-world evidence, Medicine
وصف الملف: electronic resource
العلاقة: https://doaj.org/toc/1750-1172Test
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3دورية أكاديمية
المؤلفون: Carlucci, Giuseppe, Ippisch, Robin, Slavik, Roger, Mishoe, Ashley, Blecha, Joseph, Zhu, Shaojun
المصدر: Journal of Nuclear Medicine. 62(2)
مصطلحات موضوعية: Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Clinical Trials and Supportive Activities, Biomedical Imaging, Cancer, Prevention, Aging, Urologic Diseases, Prostate Cancer, Drug Approval, Edetic Acid, Gallium Isotopes, Gallium Radioisotopes, Intersectoral Collaboration, Oligopeptides, Positron-Emission Tomography, United States, United States Food and Drug Administration, oncology: GU, PET/CT, radiochemistry, radiopharmaceuticals, Ga-68-PSMA-11, approval, FDA, new drug application, 68Ga-PSMA-11, Clinical Sciences, Nuclear Medicine & Medical Imaging, Clinical sciences
وصف الملف: application/pdf
الوصول الحر: https://escholarship.org/uc/item/8zk0024jTest
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4دورية أكاديمية
المؤلفون: Cherqui, Stephanie
المصدر: Cells. 10(12)
مصطلحات موضوعية: Medical Biotechnology, Biomedical and Clinical Sciences, Pediatric, Clinical Research, Stem Cell Research, Orphan Drug, Transplantation, Gene Therapy, Biotechnology, Rare Diseases, Kidney Disease, Stem Cell Research - Nonembryonic - Human, Genetics, Regenerative Medicine, Development of treatments and therapeutic interventions, 5.2 Cellular and gene therapies, Good Health and Well Being, Amino Acid Transport Systems, Neutral, Animals, Cystinosis, Genetic Therapy, Hematopoietic Stem Cell Transplantation, Humans, Kidney, Lysosomes, Transplantation, Homologous, cystinosis, CD34(+) hematopoietic stem and progenitor cells, gene therapy, pre-clinical studies, investigational new drug application, clinical trial, CD34+ hematopoietic stem and progenitor cells, Biological sciences, Biomedical and clinical sciences
وصف الملف: application/pdf
الوصول الحر: https://escholarship.org/uc/item/46x1155zTest
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5دورية أكاديمية
المؤلفون: Zamanian, Roham T, Pollack, Charles V, Gentile, Michael A, Rashid, Moira, Fox, John Christian, Mahaffey, Kenneth W, de Jesus Perez, Vinicio
المصدر: American Journal of Respiratory and Critical Care Medicine. 202(1)
مصطلحات موضوعية: Good Health and Well Being, Administration, Inhalation, Adult, Betacoronavirus, COVID-19, Coronavirus Infections, Familial Primary Pulmonary Hypertension, Female, Humans, Investigational New Drug Application, Nitric Oxide, Off-Label Use, Outpatients, Pandemics, Pneumonia, Viral, SARS-CoV-2, Telemedicine, Walk Test, Medical and Health Sciences, Respiratory System
وصف الملف: application/pdf
الوصول الحر: https://escholarship.org/uc/item/5hg3q6txTest
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6دورية أكاديمية
المؤلفون: Yurong Lai, Xiaoyan Chu, Li Di, Wei Gao, Yingying Guo, Xingrong Liu, Chuang Lu, Jialin Mao, Hong Shen, Huaping Tang, Cindy Q. Xia, Lei Zhang, Xinxin Ding
المصدر: Acta Pharmaceutica Sinica B, Vol 12, Iss 6, Pp 2751-2777 (2022)
مصطلحات موضوعية: Drug discovery and development, New drug application, Biologics license application, Pharmacokinetics, ADME, New modalities, Therapeutics. Pharmacology, RM1-950
وصف الملف: electronic resource
العلاقة: http://www.sciencedirect.com/science/article/pii/S2211383522001083Test; https://doaj.org/toc/2211-3835Test
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7دورية أكاديمية
المؤلفون: Anders Olsen, Reed F. Beall, Ryan P. Knox, Sean S. Tu, Aaron S. Kesselheim, William B. Feldman
مصطلحات موضوعية: Biochemistry, Molecular Biology, Pharmacology, Biotechnology, Cancer, Science Policy, Infectious Diseases, Computational Biology, therapeutic equivalence evaluations, pen 8212, cosmetic act ), b )( 2, promote timely competition, also examined competition, type 2 diabetes, protection may change, longitudinal database study, individual products approved, 9 products approved, existing insulin products, publicly available food, nda ) 8212, manufacturers may continue, 1986 8211, insulin products approved, approved insulin products, regulatory exclusivities listed, 6 years ), new drug application, device combinations approved
الإتاحة: https://doi.org/10.1371/journal.pmed.1004309.s001Test
https://figshare.com/articles/journal_contribution/Many_insulin_products_approved_during_the_study_period_were_drug-device_combinations_/24575046Test -
8دورية أكاديمية
المؤلفون: Anders Olsen, Reed F. Beall, Ryan P. Knox, Sean S. Tu, Aaron S. Kesselheim, William B. Feldman
مصطلحات موضوعية: Biochemistry, Molecular Biology, Pharmacology, Biotechnology, Cancer, Science Policy, Infectious Diseases, Computational Biology, therapeutic equivalence evaluations, pen 8212, cosmetic act ), b )( 2, promote timely competition, also examined competition, type 2 diabetes, protection may change, longitudinal database study, individual products approved, 9 products approved, existing insulin products, publicly available food, nda ) 8212, manufacturers may continue, 1986 8211, insulin products approved, approved insulin products, regulatory exclusivities listed, 6 years ), new drug application, device combinations approved
الإتاحة: https://doi.org/10.1371/journal.pmed.1004309.s002Test
https://figshare.com/articles/journal_contribution/Animal-derived_insulin_products_approved_in_1986_or_later_/24575049Test -
9دورية أكاديمية
المؤلفون: Anders Olsen, Reed F. Beall, Ryan P. Knox, Sean S. Tu, Aaron S. Kesselheim, William B. Feldman
مصطلحات موضوعية: Biochemistry, Molecular Biology, Pharmacology, Biotechnology, Cancer, Science Policy, Infectious Diseases, Computational Biology, therapeutic equivalence evaluations, pen 8212, cosmetic act ), b )( 2, promote timely competition, also examined competition, type 2 diabetes, protection may change, longitudinal database study, individual products approved, 9 products approved, existing insulin products, publicly available food, nda ) 8212, manufacturers may continue, 1986 8211, insulin products approved, approved insulin products, regulatory exclusivities listed, 6 years ), new drug application, device combinations approved
الإتاحة: https://doi.org/10.1371/journal.pmed.1004309.s003Test
https://figshare.com/articles/journal_contribution/Biosynthetic_insulin_products_approved_before_1986_/24575052Test -
10دورية أكاديمية
المؤلفون: Anders Olsen, Reed F. Beall, Ryan P. Knox, Sean S. Tu, Aaron S. Kesselheim, William B. Feldman
مصطلحات موضوعية: Biochemistry, Molecular Biology, Pharmacology, Biotechnology, Cancer, Science Policy, Infectious Diseases, Computational Biology, therapeutic equivalence evaluations, pen 8212, cosmetic act ), b )( 2, promote timely competition, also examined competition, type 2 diabetes, protection may change, longitudinal database study, individual products approved, 9 products approved, existing insulin products, publicly available food, nda ) 8212, manufacturers may continue, 1986 8211, insulin products approved, approved insulin products, regulatory exclusivities listed, 6 years ), new drug application, device combinations approved
الإتاحة: https://doi.org/10.1371/journal.pmed.1004309.s004Test
https://figshare.com/articles/journal_contribution/Originator_insulin_products_approved_from_1986_2019_/24575055Test