Bridging data/studies

This consists of information from the complete clinical data package selected for its relevance to the new region. PK, PD and early dose-response date should all be included. If a bridging clinical study between the foreign data and the new region s population is needed, this may be a PK study, or PD demonstration of efficiency or a full... 

One of the few BRIDGE case studies where data availability supported a process up to Tier 4 was the Odense river basin (Hinsby et al., 2007). The characterisation of this area ( 1050km2 see Figure 5.3.4) shows pressures from agricultural land use (68% of the surface) and surface waters (lake Arresov and the estuary of the Odense Fjord) impacted by eutrophication due to severe nutrient loads (nitrogen and phosphorus). 

As mentioned, we also carried out IR studies (a fast vibrational spectroscopy) early in our work on carbocations. In our studies of the norbornyl cation we obtained Raman spectra as well, although at the time it was not possible to theoretically calculate the spectra. Comparison with model compounds (the 2-norbornyl system and nortri-cyclane, respectively) indicated the symmetrical, bridged nature of the ion. In recent years, Sunko and Schleyer were able, using the since-developed Fourier transform-infrared (FT-IR) method, to obtain the spectrum of the norbornyl cation and to compare it with the theoretically calculated one. Again, it was rewarding that their data were in excellent accord with our earlier work. 

These situations are treated as completely new applications which should include an explanation of the decision to develop the enantiomer or racemate. Data on the existing racemate or enantiomer may be included where appropriate with bridging studies as necessary. 

The area of racemic switches where a single enantiomer is developed subsequently to a corresponding racemate which is already on the market has attracted much interest [7, 8]. A description of the preclinical and clinical development of dexketoprofen provides a detailed example of one of these racemic switches [21]. The regulations in Europe and the US both allow for the development of a single enantiomer from a racemate by the use of bridging studies between the old and new applications. One problem to be considered is how a company which was not responsible for the original development can provide equivalent data. 

Study of the relationship between the structural data and magnetic interaction in cxo-bridged binu-cleaT copper(II) compounds. M. Melnik, Coord. Chem. Rev., 1982,42,259-293 (147). 

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