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1دورية أكاديمية
المؤلفون: Prisha Patel, Judith C. Macdonald, Jayanthi Boobalan, Matthew Marsden, Ruben Rizzi, Marianne Zenon, Jinma Ren, Haitao Chu, Joseph C. Cappelleri, Satrajit Roychoudhury, Julie O’Brien, Konoha Izaki-Lee, Donna Boyce
المصدر: Frontiers in Medicine, Vol 10 (2023)
مصطلحات موضوعية: regulatory, agilities, reliance, convergence, vaccines, Medicine (General), R5-920
وصف الملف: electronic resource
العلاقة: https://www.frontiersin.org/articles/10.3389/fmed.2023.1275817/fullTest; https://doaj.org/toc/2296-858XTest
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2دورية أكاديمية
المؤلفون: Ramy Khalil, Judith C. Macdonald, Andrew Gustafson, Lina Aljuburi, Fabio Bisordi, Ginny Beakes-Read
المصدر: Frontiers in Medicine, Vol 10 (2023)
مصطلحات موضوعية: cloud, submission and approval, digital transformation and big data, dossier and approval process, structured content, health authorities, Medicine (General), R5-920
وصف الملف: electronic resource
العلاقة: https://www.frontiersin.org/articles/10.3389/fmed.2023.1233142/fullTest; https://doaj.org/toc/2296-858XTest
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3دورية أكاديمية
المؤلفون: Gentaro Tajima, Seoan Huh, Natalie Anne Schmidt, Judith C. Macdonald, Tobias Fleischmann, Keith Merrell Wonnacott
المصدر: Molecular Therapy: Methods & Clinical Development, Vol 26, Iss , Pp 74-83 (2022)
مصطلحات موضوعية: genetically modified organisms, environmental risk assessment, virus vectors, adeno-associated virus, viral shedding, multi-regional clinical trials, Genetics, QH426-470, Cytology, QH573-671
وصف الملف: electronic resource
العلاقة: http://www.sciencedirect.com/science/article/pii/S2329050122000778Test; https://doaj.org/toc/2329-0501Test
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4دورية أكاديمية
المؤلفون: Judith C. Macdonald, David C. Isom, Daniel D. Evans, Katy J. Page
المصدر: Frontiers in Medicine, Vol 8 (2021)
مصطلحات موضوعية: regulatory, digital, dynamic, cloud, review, artificial intelligence (AI), Medicine (General), R5-920
وصف الملف: electronic resource
العلاقة: https://www.frontiersin.org/articles/10.3389/fmed.2021.660808/fullTest; https://doaj.org/toc/2296-858XTest
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5
المؤلفون: Prisha Patel, Judith C. Macdonald, Jayanthi Boobalan, Matthew Marsden, Ruben Rizzi, Marianne Zenon, Jinma Ren, Haitao Chu, Joseph C. Cappelleri, Satrajit Roychoudhury, Julie O’Brien, Konoha Izaki-Lee, Donna Boyce
مصطلحات موضوعية: Dermatology, Emergency Medicine, Gastroenterology and Hepatology, Geriatrics and Gerontology, Intensive Care, Medical Genetics (excl. Cancer Genetics), Nephrology and Urology, Nuclear Medicine, Orthopaedics, Otorhinolaryngology, Pathology (excl. Oral Pathology), Radiology and Organ Imaging, Foetal Development and Medicine, Obstetrics and Gynaecology, Family Care, Primary Health Care, Medical and Health Sciences not elsewhere classified, regulatory, agilities, reliance, convergence, vaccines
الإتاحة: https://doi.org/10.3389/fmed.2023.1275817.s002Test
https://figshare.com/articles/dataset/Table_2_Regulatory_agilities_impacting_review_timelines_for_Pfizer_BioNTech_s_BNT162b2_mRNA_COVID-19_vaccine_a_retrospective_study_DOCX/24525307Test -
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المؤلفون: Thomas C. Kühler, Nadege Le Roux, Judith C. Macdonald, Rodrigo Palacios, Esteban Herrero-Martinez, Nasir Hussain, Mark Mayer
المصدر: Clinical therapeutics. 44(1)
مصطلحات موضوعية: Pharmacology, Process management, Drug Industry, business.industry, Corporate governance, Digital transformation, Information technology, COVID-19, Agency (sociology), Medicine, media_common.cataloged_instance, Humans, Pharmacology (medical), Regulatory science, Product (category theory), European Union, Public Health, European union, business, Working group, media_common
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::84b7d136eeba6f80fe0bd501f928084aTest
https://pubmed.ncbi.nlm.nih.gov/34848082Test -
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المؤلفون: Rebecca S Lumsden, Judith C. Macdonald, Julie O'Brien
المصدر: BMJ Global Health
BMJ Global Health, Vol 6, Iss 1 (2021)مصطلحات موضوعية: Medicine (General), 2019-20 coronavirus outbreak, Coronavirus disease 2019 (COVID-19), Process (engineering), Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Technical standard, Infectious and parasitic diseases, RC109-216, Public administration, Global Health, Antiviral Agents, 03 medical and health sciences, R5-920, 0302 clinical medicine, Human use, Humans, 030212 general & internal medicine, Pandemics, Health policy, SARS-CoV-2, 030503 health policy & services, Health Policy, public health, Public Health, Environmental and Occupational Health, COVID-19, Benchmarking, Legislation, Drug, Commentary, Business, 0305 other medical science, health systems
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::acc4fe9c45392994dc9cd86d4d61077bTest
https://doi.org/10.1136/bmjgh-2020-004680Test -
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المؤلفون: Helen Hartman, Judith C. Macdonald, Ira Jacobs
المصدر: mAbs
مصطلحات موضوعية: medicine.medical_specialty, Antibodies, Neoplasm, Immunology, naming, Antineoplastic Agents, Review, Pharmacology, Appropriate use, Immunology and Allergy, Medicine, Humans, biosimilars, biologics, Intensive care medicine, Biosimilar Pharmaceuticals, Drug Approval, labeling, business.industry, Treatment options, Antibodies, Monoclonal, Biosimilar, Legislation, Drug, ADR - Adverse drug reaction, Drug development, regulatory, business, interchangeability
الوصول الحر: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::a3f6b372bfa8e498c8c877a1947a931dTest
http://europepmc.org/articles/PMC4622730Test