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United States clinical trials duration

There are slight differences in the requirements for the European Union, the United States, and Japan. Duration to support Phase III trials in the EU, when they differ from the other data, is given in parentheses. Readers are referred to Guidance for Industry M3 Nonclinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals, EDA, Rockville, MD, 1997. http //www.fda.gov/cder/guidance/1855fnl.pdf [accessed September 20,2007]. [Pg.157]

In Japan and the United States, the clinical duration for Phase I, II and III trials can equal the duration of toxicity studies (Table 3.1). In Europe, a more conservative approach is adopted as longer duration studies, equivalent to those expected for marketing, are needed for Phase III trials (Table 3.2). [Pg.120]

The clinically recommended dose of bivalirudin was originally 1.0 mg/kg bolus followed by infusion at 2.5 mg/kg/hr for four hours. After the REPLACE-2 trial, the dose was reduced to 0.75 mg/kg bolus followed by an infusion of 1.75 mg/kg/hr for the duration of the PCI procedure, which is the dosage approved in the United States and Europe. The postprocedural infusion can be continued for up to four hours. It is recommended that ACT should be measured five minutes after bolus dosing, where ACT is expected to be 320 to 400 seconds, and a second bolus of 0.3 mg/kg should be administered if needed [if ACT is less than 225 seconds according to the EMEA Sm PC (68)]. Bivalirudin shows a linear correlation between the dose or plasma concentration and... [Pg.102]

In Europe and the United States, 2-week studies are the minimum duration. In Japan. 2-week nonrodent and 4-week studies are needed. Note Support for phase 3 clinical trials in Europe and for marketing in all regions required longer minimum duration toxicology studies than listed in the table. [Pg.40]

Table 6.1 Duration of repeated-dose toxicity studies to support phase I and phase II clinical trials in the EU and phase I, II and III clinical trials in the United States and Japan3... Table 6.1 Duration of repeated-dose toxicity studies to support phase I and phase II clinical trials in the EU and phase I, II and III clinical trials in the United States and Japan3...
Although infant botulism was not recognized until a large outbreak occurred in California in 1976, it is currently the most prevalent form of botulism in the United States, accounting for approximately 70% of aU cases. Because infant botulism results from a continual elaboration of BoNT, it is more effectively treated by antitoxin than is foodbome botulism. Recently concluded clinical trials carried out with a human botulinum immune globulin (BIG) has revealed a greater than two-fold reduction in the mean duration of hospitalization in infants treated with BIG treatment was effective even when infusion was initiated several days after the onset of symptoms (Amon, personal communication). [Pg.387]


See other pages where United States clinical trials duration is mentioned: [Pg.48]    [Pg.120]    [Pg.165]    [Pg.176]    [Pg.41]    [Pg.346]    [Pg.1643]    [Pg.70]    [Pg.67]    [Pg.512]    [Pg.307]    [Pg.563]    [Pg.2536]    [Pg.228]    [Pg.944]    [Pg.341]    [Pg.172]    [Pg.307]    [Pg.451]   
See also in sourсe #XX -- [ Pg.140 , Pg.141 ]




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