Bridging Studies For Development of Drugs that Companies Plan to Market in Other Cultures
Do you think that bridging studies should be required for the development of drugs that companies plan to market in other cultures?
The bridging studies are fashioned to permit people to the conduit from the original population and region to a new area (Barron, 2015). Therefore, bridging studies are carried out in a new field to offer clinical data on dosage, safety, dose regimen, and efficacy in the new region, which allows extrapolation of the foreign clinical data to the populace of the new region. Consequently, drugs and medicines are grouped as insensitive to cultural factors. Hence, the type of bridging study that is required depends upon experience with extrinsic cultural factors and the drug class that affects medicine’s dose response, safety, and efficacy. However, bridging studies are not needed in two circumstances. These include firstly if the medicine is ethnically insensitive with similar extrinsic factors. Secondly, if the medicine is ethnically sensitive and the external factors are not similar, and there is knowledge with the related compounds of pharmacology.
Conversely, it is paramount to provide the Bridging study with pharmacologic endpoints. Since they are required when the region is ethnically dissimilar, the drug is ethnically sensitive, however with similar extrinsic factors (Gupta, 2011). Nonetheless, a clinical study in a new area using established surrogate endpoint or pharmacologic endpoint can bridge unrelated data. Therefore, when there is some disbelief about insufficient clinical knowledge in medicine, drug class, or choice of the dose is strange, or different between two regions, then controlled clinical trial and bridging studies are very necessary. For instance, for medicines that may stimulate increased unpleasant drug reaction, then it is paramount to carry out a premarketing clinical trial to illuminate and explain local safety concerns.Order Unique Answer Now