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项与 Shire LLC 相关的药物

Nitrofurazone

呋喃西林

靶点

PFOR

作用机制

PFOR抑制剂

在研机构

原研机构

在研适应症

非在研适应症

最高研发阶段批准上市

首次获批国家/地区

美国

首次获批日期1945-10-04

100 项与 Shire LLC 相关的临床结果

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项与 Shire LLC 相关的文献（医药）

2015-09-01·Therapeutic Innovation & Regulatory Science4区 · 医学

Best Practice Recommendations Regarding the Assessment of Palatability and Swallowability in the Development of Oral Dosage Forms for Pediatric Patients

4区 · 医学

Article

作者: Lombardi, Don ; Thompson, Charles ; Sjostedt, Philip ; Squires, Liza

The palatability of oral drugs influences patient adherence to prescribed regimens, especially for children. Various factors influence palatability, including smell, taste, texture, and dose volume. Evaluation of these factors plays an important role in pediatric drug development and is a target for regulatory scrutiny. The Global Alliance for Pediatric Therapeutics, a public-private consortium under the guidance of the Institute for Pediatric Innovation, convened the Alliance Palatability Working Group to discuss the issues related to the assessment of palatability in the development of pediatric oral dosage forms. An extensive scientific literature search was conducted, in addition to a multicompany industry survey and a series of workshops with the Alliance Palatability Working Group. Based on the results, 3 best practice recommendations emerged regarding the assessment of palatability for oral dosage forms in pediatric drug development. These best practice recommendations offer researchers guidance for the preclinical and clinical assessment of palatability of oral dosage forms and serve to operationalize the assessment process within the overall drug development program.

2014-03-01·Journal of Renal Nutrition3区 · 医学

Dietary Trends and Management of Hyperphosphatemia Among Patients With Chronic Kidney Disease: An International Survey of Renal Care Professionals

3区 · 医学

Article

作者: Lindley, Elizabeth ; Pancířová, Jitka ; Fouque, Denis ; Kernc, Jennifer ; Rogers, Susan ; Cruz Casal, Maria ; Copley, J Brian

OBJECTIVEThe objective of this study was to review the opinions and experiences of renal care professionals to examine dietary trends among patients with chronic kidney disease (CKD) and problems associated with the clinical management of hyperphosphatemia.DESIGNThis was an online survey comprising open and closed questions requesting information on patient dietary trends and the clinical management of hyperphosphatemia. The study was conducted in 4 European countries (the Netherlands, Spain, Sweden, and the United Kingdom).SUBJECTSParticipants were 84 renal care professionals.INTERVENTIONThis was an online survey.MAIN OUTCOME MEASUREResponder-reported experiences and perceptions of patient dietary trends and hyperphosphatemia management were assessed.RESULTSMost survey responders (56%) observed an increase in the consumption of processed convenience food, 48% noticed an increase in the consumption of foods rich in phosphorus-containing additives, and 60% believed that there has been a trend of increasing patient awareness of the phosphorus content of food. Patients undergoing hemodialysis (HD) were most likely to experience difficulties in following advice on dietary phosphorus restriction (38% of responders estimated that 25-50% of their patients experienced difficulties, and 29% estimated that 51-75% experienced difficulties). Maintaining protein intake and restricting dietary phosphorus were perceived as being equally important by at least half of responders for predialysis patients (56%) and for those undergoing peritoneal dialysis and HD (54% and 50%, respectively). There were international variations in dietary trends and hyperphosphatemia management.CONCLUSIONAlthough most responders have observed a trend of increasing awareness of the phosphorus content of food among patients with CKD, the survey results indicate that many patients continue to experience difficulties when attempting to restrict dietary phosphorus. The survey responses reflect the global trend of increasing consumption of processed convenience foods and phosphorus-containing additives, which has implications for the management of hyperphosphatemia in patients with CKD.

2013-09-01·Therapeutic Innovation & Regulatory Science4区 · 医学

Industry Survey on Current Practices in the Assessment of Palatability and Swallowability in the Development of Pediatric Oral Dosage Forms

4区 · 医学

Article

作者: Lombardi, Donald P ; Sjostedt, Philip ; Squires, Liza A ; Thompson, Charles A

An industry-based survey was conducted by the Global Alliance for Pediatric Therapeutics in February 2013 to determine and evaluate the current industry practices in the assessment of palatability and swallowability during the development of pediatric oral solid dosage forms, including the design and statistical analysis of such studies. In addition, the survey was designed to identify areas where regulatory guidance is most needed. The survey was distributed to 6 research-based pharmaceutical companies and to members of the American Academy of Pediatrics' Provisional Section on Advances in Therapeutics and Technology. In general, while all responding companies have experience developing pediatric medicines, there was no consistent approach among respondents to the assessment of organoleptic properties of solid dosage forms, including excipients. In the direct assessment of palatability in pediatric patients in clinical trials, the survey identified that a variety of methods is used across companies, including visual analogue scales, simple and complex hedonic scales, and simplistic Likert-type scales. No assessment method identified was acknowledged as validated or with any statistical correlates, with many respondents stating that scales used in the pharmaceutical industry are adapted from the significant work conducted in the food service industry. Based on findings from the industry survey, the authors believe that there is an opportunity for consensus of the assessment of palatability and swallowability in the development of pediatric oral solid dosage forms.

100 项与 Shire LLC 相关的药物交易

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100 项与 Shire LLC 相关的转化医学

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