Alloreactivity of Allogeneic Mesenchymal Stem/Stromal Cells and Other Cellular Therapies: A Concise Review by Kiran Shah, Nirali Shah, Fatameh Ghassemi, Carolyn Ly, Teena George, Carla Lutz, Huseyin Sumer

“…The area has been further strengthened with the approval of Chimeric Antigen Receptor added on T cells (CAR-T) therapies by the regulatory authorities USA’s Food and Drugs Administration (FDA), European Medical Agency (EMA), the Australian Therapeutic Goods Administration (TGA), and in many countries in 2017 to treat hematological cancers. …”
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Denosumab-Induced Severe Hypocalcaemia in Chronic Kidney Disease by Ryan Jalleh, Gopal Basu, Richard Le Leu, Shilpanjali Jesudason

“…Despite Therapeutic Goods Administration (TGA) notifications in 2013, we have subsequently encountered several cases of denosumab-induced hypocalcaemia, raising concern about lack of widespread awareness among prescribing practitioners. …”
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The complexities of elexacaftor/tezacaftor/ivacaftor therapeutic drug monitoring in a person with cystic fibrosis and Mycobacterium abscessus pulmonary disease by Claire Y Mou, Daniel J Henderson, Angela G Matson, Karen M Herd, David W Reid, Timothy Riddles, Ellie Johnson, Brett McWhinney, Rebecca Swenson, Andrew Burke, Ieuan E S Evans

“…Utilising National Association of Testing Authorities (NATA) accredited assays and target considerations published by the Therapeutic Goods Administration (TGA), Australia, ETI plasma concentration variability was monitored over the course of an acute admission with added complexity from an antibiotic regimen including rifabutin, a moderate cytochrome P450 3A (CYP3A) inducer, and clofazimine, a mild CYP3A inhibitor. …”
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Effects of a multicomponent resistance-based exercise program with protein, vitamin D and calcium supplementation on cognition in men with prostate cancer treated with ADT: seconda... by Helen Macpherson, Robin M Daly, Patricia M Livingston, Declan G Murphy, Patrick J Owen, Timo Rantalainen, Niamh L Mundell, Jeremy L Millar, Steve F Fraser, Jack Dalla Via, Stephen J Foulkes

“…Exercise training adherence below recommended guidelines does not support cognitive health in men treated with ADT for prostate cancer.Trial registration number Australian and New Zealand Clinical Trial Registry (ACTRN12614000317695, registered 25/03/2014) and acknowledged under the Therapeutic Goods Administration Clinical Trial Notification Scheme (CT-2015-CTN-03372-1 v1).…”
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Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process by Breanne Stewart, Pirkko Lepola, Gunter F. Egger, Fahimeda Ali, Albert J. Allen, Albert J. Allen, Alysha K. Croker, Andrew J. Davidson, Pamela Dicks, Saul N. Faust, Saul N. Faust, Dionna Green, Collin Hovinga, Collin Hovinga, Agnes V. Klein, Robyn Langham, Hidefumi Nakamura, Laura Pioppo, Shiva Ramroop, Michiyo Sakiyama, Isabel Sanchez Vigil de la Villa, Junko Sato, Donna L. Snyder, Mark A. Turner, Mark A. Turner, Sarah Zaidi, Kanecia Zimmerman, Kanecia Zimmerman, Thierry Lacaze-Masmonteil

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