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Page 1
Recommendations on: internal standard criteria, stability, incurred sample reanalysis and recent 483s by the Global CRO Council for Bioanalysis.
Lowes S, Jersey J, Shoup R, Garofolo F, Savoie N, Mortz E, Needham S, Caturla MC, Steffen R, Sheldon C, Hayes R, Samuels T, Di Donato L, Kamerud J, Michael S, Lin ZJ, Hillier J, Moussallie M, de Souza Teixeira L, Rocci M, Buonarati M, Truog J, Hussain S, Lundberg R, Breau A, Zhang T, Jonker J, Berger N, Gagnon-Carignan S, Nehls C, Nicholson R, Hilhorst M, Karnik S, de Boer T, Houghton R, Smith K, Cojocaru L, Allen M, Harter T, Fatmi S, Sayyarpour F, Vija J, Malone M, Heller D. Lowes S, et al. Among authors: di donato l. Bioanalysis. 2011 Jun;3(12):1323-32. doi: 10.4155/bio.11.135. Bioanalysis. 2011. PMID: 21679026
Formation of a Global Contract Research Organization Council for Bioanalysis.
Premkumar N, Lowes S, Jersey J, Garofolo F, Dumont I, Masse R, Stamatiou B, Caturla MC, Steffen R, Malone M, Offman E, Samuels T, Oldfield P, Di Donato L, Fast D, Tang D, Moussallie M, Doughty J, Rocci M, Buonarati M, Gouty D, Dadgar D, Stamatopoulos J, Breau A, Ntsikoussalabongui B, Bouhajib M, Nicholson B, Tacey R, Ketelaar P, Briscoe C, Karnik S, Wieling J, Smith JK, Reid MJ, Lelacheur R, Chapdelaine J, Fatmi S, Sayyarpour F, Fang X, Cook J, Browne D. Premkumar N, et al. Among authors: di donato l. Bioanalysis. 2010 Nov;2(11):1797-800. doi: 10.4155/bio.10.165. Bioanalysis. 2010. PMID: 21083485 No abstract available.
9th GCC closed forum: CAPA in regulated bioanalysis; method robustness, biosimilars, preclinical method validation, endogenous biomarkers, whole blood stability, regulatory audit experiences and electronic laboratory notebooks.
Hayes R, LeLacheur R, Dumont I, Couerbe P, Safavi A, Islam R, Pattison C, Cape S, Rocci M, Briscoe C, Cojocaru L, Groeber E, Silvestro L, Bravo J, Shoup R, Verville M, Zimmer J, Caturla MC, Khadang A, Bourdage J, Hughes N, Fatmi S, Di Donato L, Sheldon C, Keyhani A, Satterwhite C, Yu M, Fiscella M, Hulse J, Lin ZJ, Garofolo W, Savoie N, Xiao YQ, Kurylak K, Harris S, Saxena M, Buonarati M, Lévesque A, Boudreau N, Lin J, Khan MU, Ray G, Liu Y, Xu A, Soni G, Ward I, Kingsley C, Ritzén H, Tabler E, Nicholson B, Bennett P, van de Merbel N, Karnik S, Bouhajib M, Wieling J, Mulvana D, Ingelse B, Allen M, Malone M, Fang X. Hayes R, et al. Among authors: di donato l. Bioanalysis. 2016 Mar;8(6):487-95. doi: 10.4155/bio.16.16. Epub 2016 Feb 26. Bioanalysis. 2016. PMID: 26916197
Validation of a sensitive and automated 96-well solid-phase extraction liquid chromatography-tandem mass spectrometry method for the determination of desloratadine and 3-hydroxydesloratadine in human plasma.
Yang L, Clement RP, Kantesaria B, Reyderman L, Beaudry F, Grandmaison C, Di Donato L, Masse R, Rudewicz PJ. Yang L, et al. Among authors: di donato l. J Chromatogr B Analyt Technol Biomed Life Sci. 2003 Jul 25;792(2):229-40. doi: 10.1016/s1570-0232(03)00267-8. J Chromatogr B Analyt Technol Biomed Life Sci. 2003. PMID: 12860030
Timing of Cholecystectomy After Moderate and Severe Acute Biliary Pancreatitis.
Di Martino M, Ielpo B, Pata F, Pellino G, Di Saverio S, Catena F, De Simone B, Coccolini F, Sartelli M, Damaskos D, Mole D, Murzi V, Leppaniemi A, Pisanu A, Podda M; MANCTRA-1 Collaborative Group. Di Martino M, et al. JAMA Surg. 2023 Oct 1;158(10):e233660. doi: 10.1001/jamasurg.2023.3660. Epub 2023 Oct 11. JAMA Surg. 2023. PMID: 37610760 Free PMC article.
Infected pancreatic necrosis: outcomes and clinical predictors of mortality. A post hoc analysis of the MANCTRA-1 international study.
Podda M, Pellino G, Di Saverio S, Coccolini F, Pacella D, Cioffi SPB, Virdis F, Balla A, Ielpo B, Pata F, Poillucci G, Ortenzi M, Damaskos D, De Simone B, Sartelli M, Leppaniemi A, Jayant K, Catena F, Giuliani A, Di Martino M, Pisanu A; MANCTRA-1 Collaborative Group. Podda M, et al. Updates Surg. 2023 Apr;75(3):493-522. doi: 10.1007/s13304-023-01488-6. Epub 2023 Mar 11. Updates Surg. 2023. PMID: 36899292 Free PMC article. Clinical Trial.
coMpliAnce with evideNce-based cliniCal guidelines in the managemenT of acute biliaRy pancreAtitis): The MANCTRA-1 international audit.
Podda M, Pacella D, Pellino G, Coccolini F, Giordano A, Di Saverio S, Pata F, Ielpo B, Virdis F, Damaskos D, De Simone B, Agresta F, Sartelli M, Leppaniemi A, Riboni C, Agnoletti V, Mole D, Kluger Y, Catena F, Pisanu A; MANCTRA-1 Collaborative Group; Principal Investigator; Steering Committee; MANCTRA-1 Coordinating Group; Local Collaborators; Argentina; Australia; Bahrain; Brazil; Bulgaria; China; Colombia; Czech Republic; Egypt; France; Georgia; Greece; Guatemala; India; Italy; Jordan; Malaysia; Mexico; Nigeria; Pakistan; Paraguay; Peru; Philippines; Poland; Portugal; Qatar; Romania; Russia; Serbia; Slovak Republic; South Africa; Spain; Sudan; Switzerland; Syria; Tunisia; Turkey; United Kingdom; Uruguay; Yemen. Podda M, et al. Pancreatology. 2022 Nov;22(7):902-916. doi: 10.1016/j.pan.2022.07.007. Epub 2022 Jul 16. Pancreatology. 2022. PMID: 35963665 Free article.
Urgent and emergency surgery for secondary peritonitis during the COVID-19 outbreak: an unseen burden of a healthcare crisis.
Fallani G, Lombardi R, Masetti M, Chisari M, Zanini N, Cattaneo GM, Filosa M, Zanzi F, Guerra E, Bonilauri S, Di Donato L, Garulli G, Lucchi A, Grassia M, Ugolini G, Pasini F, Vetrone G, Benini C, Nicosia S, Jovine E. Fallani G, et al. Among authors: di donato l. Updates Surg. 2021 Apr;73(2):753-762. doi: 10.1007/s13304-020-00943-y. Epub 2021 Jan 4. Updates Surg. 2021. PMID: 33394354 Free PMC article.
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