{"text_format":"2","workbook":"xls","n_sheets":1,"sheets":["report2"],"not_rendered":{"charts":0,"images":0,"macros":0,"external_links":1,"defined_names":3,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"run_cost":"one","rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900","formulas":"cached_only"}

{"sheet":"report2","index":0,"n_rows":60,"n_cols":5,"rows_kept":60,"cut":false,"hidden":false,"merged":[[0,2,0,3],[0,4,0,5],[1,2,1,3],[1,4,1,5],[2,2,2,3],[2,4,2,5],[3,2,3,3],[4,2,4,3],[5,2,5,3],[6,2,6,3],[7,2,7,3],[11,2,11,3],[12,2,12,3],[17,2,17,3],[17,4,17,5],[18,2,18,3],[18,4,18,5],[19,2,19,3],[20,2,20,3],[21,2,21,3],[22,2,22,3],[23,2,23,3],[35,2,35,3],[36,2,36,3],[38,2,38,3],[38,4,38,5],[39,2,39,3],[39,4,39,5],[40,2,40,3],[40,4,40,5],[41,2,41,3],[42,2,42,3],[43,2,43,3],[44,2,44,3],[45,2,45,3],[48,2,48,3],[52,2,52,3],[53,2,53,3],[57,2,57,3]],"flags":["formulas_cached_only"]}
[null,"1.","Record Nr.",null,"UNINA9910697495203321"]
[null,null,"Autore",null,"Schaefer Donald H"]
[null,null,"Titolo",null,"Ground-water quality in the carbonate-rock aquifer of the Great Basin, Nevada and Utah, 2003 [[electronic resource] /] / by Donald H. Schaefer, Susan A. Thiros, and Michael R. Rosen"]
[null,null,"Pubbl/distr/stampa",null,"Carson City, Nev. : , : U.S. Dept. of the Interior, U.S. Geological Survey, , 2006"]
[null,null,"Edizione",null,"[[Version 1.0].]"]
[null,null,"Descrizione fisica",null,"vi, 32 pages : digital, PDF file"]
[null,null,"Collana",null,"Scientific investigations report ; ; 2005-5232"]
[null,null,"Soggetti",null,"Groundwater - Nevada"]
[{"$nulls":4},"Groundwater - Utah"]
[{"$nulls":4},"Water quality - Nevada"]
[{"$nulls":4},"Water quality - Utah"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Title from PDF title screen (viewed on Mar. 6, 2006)."]
[{"$nulls":4},"\"National Water-Quality Assessment Program.\""]
[null,null,null,"Nota di bibliografia","Includes bibliographical references (pages 26-28)."]
[null,"2.","Record Nr.",null,"UNISA996203078203316"]
[null,null,"Titolo",null,"International journal of MCH and AIDS"]
[null,null,"Pubbl/distr/stampa",null,"Riverdale, Maryland : , : Global Health and Education Projects, , [2012]-"]
[null,null,"ISSN",null,"2161-864X"]
[null,null,"Descrizione fisica",null,"1 online resource"]
[null,null,"Disciplina",null,"618"]
[null,null,"Soggetti",null,"Maternal health services"]
[{"$nulls":4},"Maternal and infant welfare"]
[{"$nulls":4},"Family medicine"]
[{"$nulls":4},"HIV (Viruses) - Social aspects"]
[{"$nulls":4},"HIV Infections"]
[{"$nulls":4},"Maternal Health"]
[{"$nulls":4},"Child Health"]
[{"$nulls":4},"Social Determinants of Health"]
[{"$nulls":4},"Periodical"]
[{"$nulls":4},"Fulltext"]
[{"$nulls":4},"Internet Resources."]
[{"$nulls":4},"Periodicals."]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Periodico"]
[null,"3.","Record Nr.",null,"UNINA9910300234003321"]
[null,null,"Autore",null,"Leong James"]
[null,null,"Titolo",null,"Benefit-Risk Assessment of Medicines : The Development and Application of a Universal Framework for Decision-Making and Effective Communication / / by James Leong, Sam Salek, Stuart Walker"]
[null,null,"Pubbl/distr/stampa",null,"Cham : , : Springer International Publishing : , : Imprint : Adis, , 2015"]
[null,null,"ISBN",null,"3-319-15805-8"]
[null,null,"Edizione",null,"[1st ed. 2015.]"]
[null,null,"Descrizione fisica",null,"1 online resource (326 p.)"]
[null,null,"Disciplina",null,"306"]
[{"$nulls":4},"353998"]
[{"$nulls":4},"610"]
[null,null,"Soggetti",null,"Pharmacy"]
[{"$nulls":4},"Medicine - Research"]
[{"$nulls":4},"Drug Safety and Pharmacovigilance"]
[{"$nulls":4},"Quality of Life Research"]
[null,null,"Lingua di pubblicazione",null,"Inglese"]
[null,null,"Formato",null,"Materiale a stampa"]
[null,null,null,"Livello bibliografico","Monografia"]
[null,null,null,"Note generali","Description based upon print version of record."]
[null,null,null,"Nota di bibliografia","Includes bibliographical references."]
[null,null,"Nota di contenuto",null,"Prologue -- Preface -- Overview -- Approaches to utilising decision-making framework -- Benefit-risk assessment of medicines by pharmaceutical companies and regulatory authorities -- Development of a universal benefit-risk framework and template -- Implementation of the benefit-risk assessment template by mature agencies -- Implementation of the benefit- risk summary template by a maturing agency: A case study -- Communicating benefit-risk decisions by US FDA, EMA, TGA and Health Canada -- Conclusions and future directions -- References."]
[null,null,null,"Sommario/riassunto","This book proposes and investigates a universal framework, and accompanying documentation system, to facilitate and catalogue benefit-risk decisions; a valuable addition to the benefit-risk toolbox. Over the past decade, pharmaceutical companies and regulatory agencies have been reviewing the benefit-risk assessment of medicines with a view to developing a structured, systematic, standardized approach. Examining the evaluation of such an approach by several mature regulatory authorities ensures that the reader gains a unique insight into the ongoing debate in this area. The field of benefit-risk assessment continues to evolve at a rapid pace due to political and societal pressure, as is reflected in the recent FDA PUDFA agreement as "]
[{"$nulls":4},"well as in the EMA 2015 Roadmap. Rather than provide a comprehensive snap-shot of this constantly changing environment, this book evaluates selected current approaches to benefit-risk assessment. The strengths and weaknesses of publicly available documents in communicating benefit-risk decisions to stakeholders are reviewed, and these evaluations are used to inform development of a prospective framework that could be used to harmonise procedures globally."]