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Page 1
Showing results for dose wg
Search for Dotse WG instead (1 results)
PK/PD and Bioanalytical Considerations of AAV-Based Gene Therapies: an IQ Consortium Industry Position Paper.
Kavita U, Sun K, Braun M, Lembke W, Mody H, Kamerud J, Yang TY, Braun IV, Fang X, Gao W, Gupta S, Hofer M, Liao MZ, Loo L, McBlane F, Menochet K, Stubenrauch KG, Upreti VV, Vigil A, Wiethoff CM, Xia CQ, Zhu X, Jawa V, Chemuturi N. Kavita U, et al. AAPS J. 2023 Jul 31;25(5):78. doi: 10.1208/s12248-023-00842-1. AAPS J. 2023. PMID: 37523051 Review.
This position paper comes from the Novel Modalities Working Group (WG), part of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ). ...Last, best practices and recommendations for use of clinical and nonclinical data to project human …
This position paper comes from the Novel Modalities Working Group (WG), part of the International Consortium for Innovation and Quali …
Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia.
Byrd JC, Harrington B, O'Brien S, Jones JA, Schuh A, Devereux S, Chaves J, Wierda WG, Awan FT, Brown JR, Hillmen P, Stephens DM, Ghia P, Barrientos JC, Pagel JM, Woyach J, Johnson D, Huang J, Wang X, Kaptein A, Lannutti BJ, Covey T, Fardis M, McGreivy J, Hamdy A, Rothbaum W, Izumi R, Diacovo TG, Johnson AJ, Furman RR. Byrd JC, et al. N Engl J Med. 2016 Jan 28;374(4):323-32. doi: 10.1056/NEJMoa1509981. Epub 2015 Dec 7. N Engl J Med. 2016. PMID: 26641137 Free PMC article. Clinical Trial.
METHODS: In this uncontrolled, phase 1-2, multicenter study, we administered oral acalabrutinib to 61 patients who had relapsed CLL to assess the safety, efficacy, pharmacokinetics, and pharmacodynamics of acalabrutinib. Patients were treated with acalabrutinib at a dose o …
METHODS: In this uncontrolled, phase 1-2, multicenter study, we administered oral acalabrutinib to 61 patients who had relapsed CLL to asses …
Gene therapy with adeno-associated virus vector 5-human factor IX in adults with hemophilia B.
Miesbach W, Meijer K, Coppens M, Kampmann P, Klamroth R, Schutgens R, Tangelder M, Castaman G, Schwäble J, Bonig H, Seifried E, Cattaneo F, Meyer C, Leebeek FWG. Miesbach W, et al. Blood. 2018 Mar 1;131(9):1022-1031. doi: 10.1182/blood-2017-09-804419. Epub 2017 Dec 15. Blood. 2018. PMID: 29246900 Free PMC article. Clinical Trial.
In the low-dose cohort, mean endogenous FIX activity increased to 4.4 IU/dL. ...Limited, asymptomatic, and transient alanine aminotransferase elevations in the low-dose (n = 1) and higher-dose (n = 2) cohorts were treated with prednisolone. ...
In the low-dose cohort, mean endogenous FIX activity increased to 4.4 IU/dL. ...Limited, asymptomatic, and transient alanine aminotra …
Radiation dose management systems-requirements and recommendations for users from the ESR EuroSafe Imaging initiative.
Loose RW, Vano E, Mildenberger P, Tsapaki V, Caramella D, Sjöberg J, Paulo G, Torresin A, Schindera S, Frija G, Damilakis J; European Society of Radiology (ESR). Loose RW, et al. Eur Radiol. 2021 Apr;31(4):2106-2114. doi: 10.1007/s00330-020-07290-x. Epub 2020 Sep 21. Eur Radiol. 2021. PMID: 32959080 Free PMC article.
The EuroSafe Imaging campaign of the European Society of Radiology created a working group (WG) on "Dose Management" with the aim to provide European recommendations on the implementation of dose management systems (DMS) in clinical practice. The WG fo …
The EuroSafe Imaging campaign of the European Society of Radiology created a working group (WG) on "Dose Management" with the …
A Phase 1/2 Study of a Respiratory Syncytial Virus Prefusion F Vaccine With and Without Adjuvant in Healthy Older Adults.
Baber J, Arya M, Moodley Y, Jaques A, Jiang Q, Swanson KA, Cooper D, Maddur MS, Loschko J, Gurtman A, Jansen KU, Gruber WC, Dormitzer PR, Schmoele-Thoma B. Baber J, et al. J Infect Dis. 2022 Dec 13;226(12):2054-2063. doi: 10.1093/infdis/jiac189. J Infect Dis. 2022. PMID: 35543281 Free PMC article. Clinical Trial.
METHODS: Primary cohort participants were equally randomized to 1 of 7 RSVpreF formulations: 60 g with either Al(OH)3 or CpG/Al(OH)3, 120 g with either Al(OH)3 or CpG/Al(OH)3, 240 g with either Al(OH)3 or CpG/Al(OH)3, 240 g unadjuvanted, or placebo, administered concomitantly wit …
METHODS: Primary cohort participants were equally randomized to 1 of 7 RSVpreF formulations: 60 g with either Al(OH)3 or CpG/Al(OH)3, 120 g …
Hemi-ablative low-dose-rate prostate brachytherapy for unilateral localised prostate cancer.
Langley S, Uribe J, Uribe-Lewis S, Franklin A, Perna C, Horton A, Cunningham M, Higgins D, Deering C, Khaksar S, Laing R. Langley S, et al. BJU Int. 2020 Mar;125(3):383-390. doi: 10.1111/bju.14948. Epub 2019 Dec 23. BJU Int. 2020. PMID: 31705700 Clinical Trial.
Only HG patients showed a return to baseline urinary scores as early as 12 months. Sexual potency was conserved in 73% and 67% of HG and WG patients, respectively (P = 0.84). Post-implant prostate-specific antigen (PSA) kinetics revealed that baseline PSA was reduced at 24 …
Only HG patients showed a return to baseline urinary scores as early as 12 months. Sexual potency was conserved in 73% and 67% of HG and …
CADORmed: a tool for internal dose assessment.
Landry B, Breustedt B, Castellani CM, Lopez MA, Sierra I, Navarro JF, Roberts G. Landry B, et al. Radiat Prot Dosimetry. 2023 May 24;199(8-9):922-929. doi: 10.1093/rpd/ncad093. Radiat Prot Dosimetry. 2023. PMID: 37225218
CADORmed is a free bespoke Excel tool for committed effective dose assessment using latest dose coefficients from ICRP OIR publications. ...The validation of the tool has been included in the work plan of EURADOS WG 7. The validation plan has been defined and …
CADORmed is a free bespoke Excel tool for committed effective dose assessment using latest dose coefficients from ICRP OIR pub …
Toward 3D dose verification of an electronic brachytherapy source with a plastic scintillation detector.
Georgi P, Kertzscher G, Nyvang L, Šolc J, Schneider T, Tanderup K, Johansen JG. Georgi P, et al. Med Phys. 2022 May;49(5):3432-3443. doi: 10.1002/mp.15568. Epub 2022 Mar 3. Med Phys. 2022. PMID: 35196404 Free PMC article.
Dose profiles were measured along two perpendicular axes at five different SDDs with step sizes down to 0.5 mm. ...The measured dose profiles showed dose gradients at the profile edges of more than 50%/mm at 5 mm depth and 15%/mm at 50 mm depth. ...
Dose profiles were measured along two perpendicular axes at five different SDDs with step sizes down to 0.5 mm. ...The measured do …
Discovery of ecnoglutide - A novel, long-acting, cAMP-biased glucagon-like peptide-1 (GLP-1) analog.
Guo W, Xu Z, Zou H, Li F, Li Y, Feng J, Zhu Z, Zheng Q, Zhu R, Wang B, Li Y, Hao S, Qin H, Jones CL, Adegbite E, Telusca L, Fenaux M, Zhong W, Junaidi MK, Xu S, Pan H. Guo W, et al. Mol Metab. 2023 Sep;75:101762. doi: 10.1016/j.molmet.2023.101762. Epub 2023 Jun 24. Mol Metab. 2023. PMID: 37364710 Free PMC article. Clinical Trial.
A Phase 1, double-blind, randomized, placebo-controlled, single (SAD) and multiple ascending dose (MAD) study was conducted to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous ecnoglutide injection in healthy participants. ...
A Phase 1, double-blind, randomized, placebo-controlled, single (SAD) and multiple ascending dose (MAD) study was conducted to evalua …
Wegener's Granulomatosis vasculitis and granuloma.
Schilder AM. Schilder AM. Autoimmun Rev. 2010 May;9(7):483-7. doi: 10.1016/j.autrev.2010.02.006. Epub 2010 Feb 13. Autoimmun Rev. 2010. PMID: 20156603 Review.
Despite intensified maintenance regimens and new possibilities of biologic therapies in WG the relapse rate is high. Even patients treated with high dose cytotoxic therapies in autologous stem cell treatment protocols have shown relapses in the course of disease. In …
Despite intensified maintenance regimens and new possibilities of biologic therapies in WG the relapse rate is high. Even patients tr …
648 results