Package insert characteristics

B. Summary of Product Characteristics Labei and Package insert... 

TABLE 14.3. Comparison of Clinical Parameters for 1-3 (Briley, 1998 Lantz et al., 2003 Thomson Micromedex Healthcare Series Cymbalta US Package Insert and European Summary of Product Characteristics)... 

Cymbalta US Package Insert and European Summary of Product Characteristics. 

Analysis of Adverse Effect Dose-Response Information. An integrated analysis of all data from animal and human studies that affect the dose-response and blood level-response relationships of adverse events, the method of dose selection, the choice of dose interval, and dosing recommendations in the package insert should be performed. The effect of demographics and other patient characteristics on the dose-response relationships should be explored. 

FDA-cleared tests for the detection of CT and GC from clinical specimens (Table 42-4) can use a variety of specimens, including cervical swabs, urethral swabs, and urine from both asymptomatic and symptomatic mdividuals. Not aU assays are approved for aU conditions, and the current assays are not FDA-cleared for oral, rectal, respiratory, or conjunctival specimens. The performance characteristics of the assays vary (details are available in the package inserts) however, some general comments can be made... 

There can be no doubt that the principles that underlie European labeling are the same as those enumerated in other jurisdictions. Consistency of promotional materials with the approved package insert, the absence of misleading information in package inserts, fair balance, absence of relevant omissions and defensibility of all statements from the clinical trials database are also characteristic of good European labeling. 

Summary of Product Characteristics (SPC), Data Sheet and Package Insert (PI)... 

A method which circumvents many of the disadvantages of the transmission line and cavity perturbation technique was pioneered by Stuchley and Stuchley (1980). This technique calculates the dielectric parameters from the microwave characteristics of the reflected signal at the end of an open-ended coaxial line inserted into a sample to be measured. This technique has been commercialized by Hewlett Packard with their development of a user-friendly software package (Hewlett Packard 1991) to be used with their network analyzer (Hewlett Packard 1985). This technique is outstanding because of its simplicity of automated execution as well as the fact that it allows measurements to be made over the entire frequency spectrum from 0.3 MHz to 20 GHz. 

Summary of product characteristics samples of packaging, labels, inserts. Expert reports critical evaluations of the... 

Summary of product characteristics samples of packaging, labels, inserts. 

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