Search Results - "Food and Drug Administration"

Establishing the suitability of model‐integrated evidence to demonstrate bioequivalence for long‐acting injectable and implantable drug products: Summary of workshop by Yuqing Gong, Peijue Zhang, Miyoung Yoon, Hao Zhu, Ameya Kohojkar, Andrew C. Hooker, Murray P. Ducharme, Jogarao Gobburu, Géraldine Cellière, Parmesh Gajjar, Bing V. Li, Raja Velagapudi, Yu Chung Tsang, Anna Schwendeman, James Polli, Lanyan Fang, Robert Lionberger, Liang Zhao

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Polyols - What do we know about their impact on the gut microbiome? by Magda Wojtuś, Sebastian Tomaszuk, Karolina Wąsik

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Mitochondrion-targeted RNA therapies as a potential treatment strategy for mitochondrial diseases by Timofei Chernega, Jaehyoung Choi, Leonardo Salmena, Ana Cristina Andreazza

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A retrospective pharmacovigilance study of post-marketing safety concerns with cefuroxime by Cheng Jiang, Xiaoxiao Zheng, Ping Li, Jiancheng Qian, Qin Li

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The Policy of Subsidy Elimination from Currency Allocated to Pharmaceutical Sector in Iran; Concerns of Patients, Payers, and Industry by Amir Hashemi, Shekoufeh Nikfar

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Ethanol Pharmacokinetics in Neonates and Infants by Elizabeth Marek, PharmD, Walter K. Kraft, MD

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Biological Properties and Clinical Significance of Lipoprotein-Associated Phospholipase A2 in Ischemic Stroke by Shuang Zhang, Shuchun Huang, Dingju Hu, Fenglong Jiang, Yanli Lv, Guoqi Liu

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PHARMACEUTICAL EXCIPIENTS: GLOBAL REGULATORYISSUES by Harish Dureja, Dinesh Kumar

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Thyrotoxicosis after massive triiodothyronine (LT3) overdose: a coast-to-coast case series and review by Zhiheng H He, Yan Li, Nitin Trivedi, Sabrina Gill, James V Hennessey

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Targeted approaches in the treatment of osteoporosis: differential mechanism of action of denosumab and clinical utility by Cavalli L, Brandi ML

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The good, the bad, and the ugly of medication coverage: Is altering a diagnosis to ensure medication coverage ethical? by Gillian Weston, BS, Marti J. Rothe, MD, Barry D. Kels, MD, JD, Jane M. Grant-Kels, MD

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Bortezomib for the Treatment of Hematologic Malignancies: 15 Years Later by Pawel Robak, Tadeusz Robak

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An update to monoclonal antibody as therapeutic option against COVID-19 by Paroma Deb, Md. Maruf Ahmed Molla, K.M. Saif-

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Targeted therapies with companion diagnostics in the management of breast cancer: current perspectives by Myers MB

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A review of nabilone in the treatment of chemotherapy-induced nausea and vomiting by Mark A Ware, Paul Daeninck, Vincent Maida

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The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA by Ioana Gherghescu, M. Begoña Delgado-Charro

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Doxylamine succinate–pyridoxine hydrochloride (Diclegis) for the management of nausea and vomiting in pregnancy: an overview by Nuangchamnong N, Niebyl J

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Stem cells as a promising therapeutic direction for the treatment of serious diseases by T.A. Sprynsian

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Characteristics and Spectrum of Cardiotoxicity Induced by Various Antipsychotics: A Real-World Study From 2015 to 2020 Based on FAERS by Luyao He, Yimin Yu, Yumei Wei, Jingjing Huang, Yifeng Shen, Huafang Li

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A framework for the assessment and implementation of diagnostics in outbreak situations by Elliot P. Cowan

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