المؤلفون: Rim MH; Northwestern Medicine, Chicago, IL, USA., Karas BL; Northwestern Medicine, Chicago, IL, USA., Barada F; Northwestern Medicine, Chicago, IL, USA., Dean C; Northwestern Medicine, Chicago, IL, USA., Levitsky AM; IPD Analytics, Aventura, FL, USA.

المصدر: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists [Am J Health Syst Pharm] 2024 Aug 12; Vol. 81 (16), pp. 733-738.

نوع المنشور: Journal Article; Review

بيانات الدورية: Publisher: Oxford University Press Country of Publication: England NLM ID: 9503023 Publication Model: Print Cited Medium: Internet ISSN: 1535-2900 (Electronic) Linking ISSN: 10792082 NLM ISO Abbreviation: Am J Health Syst Pharm Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , United States Food and Drug Administration*, Humans ; United States ; Pharmacists/organization & administration ; Rare Diseases/drug therapy

المؤلفون: Schuhmacher A; Technische Hochschule Ingolstadt, THI Business School, Esplanade 10, D-85049 Ingolstadt, Germany; University of St. Gallen, Institute of Technology Management, Dufourstrasse 40a, CH-9000 St. Gallen, Switzerland. Electronic address: alexander.schuhmacher@thi.de., Gassmann O; University of St. Gallen, Institute of Technology Management, Dufourstrasse 40a, CH-9000 St. Gallen, Switzerland., Hinder M; Novartis, Development, Patient Safety, Forum 1, CH-4002 Basel, Switzerland; Fresenius University of Applied Sciences, Moritzstr. 17a, D-65185 Wiesbaden, Germany., Hartl D; University of Tübingen, Hoppe-Seyler-Strasse 1, D-72076 Tübingen, Germany; Granite Bio, Aeschenvorstadt 36, CH-4051 Basel, Switzerland.

المصدر: Drug discovery today [Drug Discov Today] 2024 Sep; Vol. 29 (9), pp. 104128. Date of Electronic Publication: 2024 Aug 05.

نوع المنشور: Journal Article; Comparative Study; Review

بيانات الدورية: Publisher: Elsevier Science Ltd. Country of Publication: England NLM ID: 9604391 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1878-5832 (Electronic) Linking ISSN: 13596446 NLM ISO Abbreviation: Drug Discov Today Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Drug Industry*, Humans ; United States ; United States Food and Drug Administration

المؤلفون: Smith HL; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Bensman TJ; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Mishra S; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Li X; Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Dixon CA; Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Sheikh J; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., McMaster OG; Division of Pharmacology/Toxicology for Infectious Diseases, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Joshi A; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Rubin DB; Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Goodwin A; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Miller TJ; Division of Pharmacology/Toxicology for Infectious Diseases, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Danielsen ZY; Division of Infectious Disease Pharmacology, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Syed I; DRT Strategies, Inc, Arlington, Virginia, USA., Shukla SJ; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Iarikov D; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Kim PW; Division of Anti-Infectives, Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA., Farley JJ; Office of Infectious Diseases, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, Maryland, USA.

المصدر: The Journal of infectious diseases [J Infect Dis] 2024 Aug 16; Vol. 230 (2), pp. 505-513.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Oxford University Press Country of Publication: United States NLM ID: 0413675 Publication Model: Print Cited Medium: Internet ISSN: 1537-6613 (Electronic) Linking ISSN: 00221899 NLM ISO Abbreviation: J Infect Dis Subsets: MEDLINE

مواضيع طبية MeSH: Echinocandins*/therapeutic use , Candidiasis, Invasive*/drug therapy , Antifungal Agents*/therapeutic use , Candidemia*/drug therapy , Drug Approval*, Humans ; Adult ; United States ; United States Food and Drug Administration ; Animals ; Clinical Trials, Phase III as Topic

المؤلفون: Barreto RB; Centro de Pesquisa Oncológicas-CEPON, Rodovia Admar Gonzada, 655, Florianópolis 88034-000, SC, Brazil., Izidoro AM; Centro de Pesquisa Oncológicas-CEPON, Rodovia Admar Gonzada, 655, Florianópolis 88034-000, SC, Brazil., Miranda MHF; Centro de Pesquisa Oncológicas-CEPON, Rodovia Admar Gonzada, 655, Florianópolis 88034-000, SC, Brazil.

المصدر: Current oncology (Toronto, Ont.) [Curr Oncol] 2024 Aug 02; Vol. 31 (8), pp. 4443-4454. Date of Electronic Publication: 2024 Aug 02.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: MDPI Country of Publication: Switzerland NLM ID: 9502503 Publication Model: Electronic Cited Medium: Internet ISSN: 1718-7729 (Electronic) Linking ISSN: 11980052 NLM ISO Abbreviation: Curr Oncol Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Antineoplastic Agents*/therapeutic use , Neoplasms*/drug therapy , United States Food and Drug Administration*, Humans ; Brazil ; United States ; Europe

المؤلفون: Hanzel J; Department of Gastroenterology and Hepatology, University Medical Center Ljubljana, University of Ljubljana, Ljubljana, Slovenia.; Alimentiv Inc, London, ON, Canada., Ma C; Department of Community Health Sciences, University of Calgary, Calgary, AB, Canada.; Alimentiv Inc, London, ON, Canada.; Division of Gastroenterology & Hepatology, Department of Medicine, University of Calgary, Calgary, AB, Canada., De Silva TA; Schulich School of Medicine and Dentistry, Western University, London, ON, Canada., Alphonsus L; Schulich School of Medicine and Dentistry, Western University, London, ON, Canada., Guizzetti L; Independent statistical consultant, London, ON, Canada., Crowley E; Division of Pediatric Gastroenterology and Hepatology, Department of Pediatrics, Children's Hospital Western Ontario, Western University, London, ON, Canada.; Alimentiv Inc, London, ON, Canada., Singh S; Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA., Jairath V; Department of Epidemiology and Biostatistics, Western University, London, ON, Canada.; Alimentiv Inc, London, ON, Canada.; Division of Gastroenterology, Department of Medicine, Western University, London, ON, Canada.

المصدر: Inflammatory bowel diseases [Inflamm Bowel Dis] 2024 Jul 03; Vol. 30 (7), pp. 1211-1214.

نوع المنشور: Comparative Study; Letter

بيانات الدورية: Publisher: Oxford University Press Country of Publication: England NLM ID: 9508162 Publication Model: Print Cited Medium: Internet ISSN: 1536-4844 (Electronic) Linking ISSN: 10780998 NLM ISO Abbreviation: Inflamm Bowel Dis Subsets: MEDLINE

مواضيع طبية MeSH: Inflammatory Bowel Diseases*/drug therapy , United States Food and Drug Administration* , Drug Approval*, Humans ; United States ; Europe ; Time Factors ; Gastrointestinal Agents/therapeutic use

المؤلفون: Dijk SW; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands.; Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands., Krijkamp E; Erasmus School of Health Policy & Management, Erasmus University Rotterdam, Rotterdam, The Netherlands., Kunst N; Centre for Health Economics, University of York, York, UK.; Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale University School of Medicine, New Haven, CT, USA., Labrecque JA; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands., Gross CP; Cancer Outcomes, Public Policy, and Effectiveness Research (COPPER) Center, Yale University School of Medicine, New Haven, CT, USA., Pandit A; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands., Lu CP; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands., Visser LE; Department of Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands.; Hospital Pharmacy, Haga Teaching Hospital, The Hague, The Netherlands., Wong JB; Division of Clinical Decision Making, Tufts Medical Center, Boston, USA., Hunink MGM; Department of Epidemiology, Erasmus University Medical Center, Rotterdam, The Netherlands.; Department of Radiology and Nuclear Medicine, Erasmus University Medical Center, Rotterdam, The Netherlands.; Center for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, MA, USA.

المصدر: Medical decision making : an international journal of the Society for Medical Decision Making [Med Decis Making] 2024 Jul; Vol. 44 (5), pp. 512-528. Date of Electronic Publication: 2024 Jun 03.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Sage Publications Country of Publication: United States NLM ID: 8109073 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1552-681X (Electronic) Linking ISSN: 0272989X NLM ISO Abbreviation: Med Decis Making Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , SARS-CoV-2* , COVID-19*/epidemiology , Decision Making* , COVID-19 Drug Treatment*, Humans ; Uncertainty ; United States ; Pandemics ; United States Food and Drug Administration ; Antibodies, Monoclonal/therapeutic use

المؤلفون: Hidaka M; Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.; Global Regulatory Sciences Japan, Bristol-Myers Squibb K.K., Tokyo, Japan., Hanaoka H; Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan.; Division of Clinical Research Center, Chiba University Hospital, Chiba, Japan., Uyama Y; Department of Regulatory Science of Medicine, Graduate School of Medicine, Chiba University, Chiba, Japan. uyama-yoshiaki@pmda.go.jp.; Regulatory Science Center, Pharmaceuticals and Medical Devices Agency, Shin‑Kasumigaseki Building, 3‑3‑2, Kasumigaseki, Chiyoda‑ku, Tokyo, 100‑0013, Japan. uyama-yoshiaki@pmda.go.jp.; Graduate School of Medicine, Nagoya University, Nagoya, Japan. uyama-yoshiaki@pmda.go.jp.

المصدر: Therapeutic innovation & regulatory science [Ther Innov Regul Sci] 2024 Jul; Vol. 58 (4), pp. 714-720. Date of Electronic Publication: 2024 Apr 04.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: Springer International Publishing Country of Publication: Switzerland NLM ID: 101597411 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 2168-4804 (Electronic) Linking ISSN: 21684790 NLM ISO Abbreviation: Ther Innov Regul Sci Subsets: MEDLINE

مواضيع طبية MeSH: Drug Industry* , Drug Approval*, Japan ; United States ; Drug Development ; Humans ; Time Factors

المؤلفون: Lenzer J, Brownlee S

المصدر: BMJ (Clinical research ed.) [BMJ] 2024 Sep 25; Vol. 386, pp. q2010. Date of Electronic Publication: 2024 Sep 25.

نوع المنشور: Journal Article

بيانات الدورية: Publisher: British Medical Association Country of Publication: England NLM ID: 8900488 Publication Model: Electronic Cited Medium: Internet ISSN: 1756-1833 (Electronic) Linking ISSN: 09598138 NLM ISO Abbreviation: BMJ Subsets: MEDLINE

مواضيع طبية MeSH: Alzheimer Disease*/drug therapy , Conflict of Interest* , United States Food and Drug Administration* , Drug Approval*/legislation & jurisprudence, Humans ; United States ; Antibodies, Monoclonal, Humanized/therapeutic use ; Drug Industry/legislation & jurisprudence ; Drug Industry/ethics

المؤلفون: Zhu Q; School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Huang HY; Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Yu AQ; Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Meng XY; The University of Melbourne, Faculty of Medicine, Dentistry and Health Sciences, Melbourne 3010, Australia., Leng Y; School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Fang H; Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Li ZW; School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Tang Y; Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China., Li J; School of Basic Medicine and Clinical Pharmacy, China Pharmaceutical University, Nanjing 211198, China., Li N; Department of Clinical Trials Center, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.

المصدر: Zhonghua zhong liu za zhi [Chinese journal of oncology] [Zhonghua Zhong Liu Za Zhi] 2024 Sep 23; Vol. 46 (9), pp. 904-910.

نوع المنشور: English Abstract; Journal Article

بيانات الدورية: Publisher: Chinese Medical Association Country of Publication: China NLM ID: 7910681 Publication Model: Print Cited Medium: Print ISSN: 0253-3766 (Print) Linking ISSN: 02533766 NLM ISO Abbreviation: Zhonghua Zhong Liu Za Zhi Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Antineoplastic Agents*/therapeutic use , United States Food and Drug Administration*, China ; United States ; Humans ; Neoplasms/drug therapy

المؤلفون: Michaeli DT; Department of Medical Oncology, National Center for Tumor Diseases, Heidelberg University Hospital, Heidelberg, Germany danielmichaeli@yahoo.com., Michaeli T; Department of Personalized Oncology, University Hospital Mannheim, Heidelberg University, Mannheim, Germany.; German Cancer Research Center-Hector Cancer Institute, University Medical Center Mannheim, Mannheim, Germany.; Division of Personalized Medical Oncology, German Cancer Research Center, Heidelberg, Germany., Albers S; Department of Trauma Surgery, Klinikum Rechts Der Isar, Technical University of Munich, Munich, Germany., Michaeli JC; Department of Obstetrics and Gynaecology, LMU University Hospital, LMU Munich, Munich, Germany.

المصدر: BMJ evidence-based medicine [BMJ Evid Based Med] 2024 Sep 20; Vol. 29 (5), pp. 333-341. Date of Electronic Publication: 2024 Sep 20.

نوع المنشور: Journal Article; Meta-Analysis

بيانات الدورية: Publisher: BMJ Publishing Group Country of Publication: England NLM ID: 101719009 Publication Model: Electronic Cited Medium: Internet ISSN: 2515-4478 (Electronic) Linking ISSN: 2515446X NLM ISO Abbreviation: BMJ Evid Based Med Subsets: MEDLINE

مواضيع طبية MeSH: Drug Approval* , Antineoplastic Agents*/therapeutic use , Randomized Controlled Trials as Topic* , Neoplasms*/drug therapy , United States Food and Drug Administration*, Humans ; United States ; Research Design ; Cross-Sectional Studies ; Treatment Outcome ; Progression-Free Survival