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steve britland - bioequivalence....

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    Evening OBJers,

    Okay you say Steve Britland, yeah we know he works for Uni of Bradford & is connected to OBJ. This was previously posted a month or two back:

    Steve Britland from the Centre for Skin Sciences, has attracted international research funding to the value of £33,000 in a collaborative development with OBJ Limited of Australia for the development of innovative bioequivalence models for use in specialised areas of transdermal drug delivery research.

    http://blogs.brad.ac.uk/from-the-vc/2011/07/07/july-update-2/

    I never really dug any further but bioequivalence models..........

    FDA state :

    The development of new drugs and the expense of clinical trials to demonstrate the safety and efficacy of innovative drugs is rewarded through granting of a period of marketing exclusivity that shields the product from competition. In anticipation of the expiration of marketing exclusivity and applicable patent protections, potential generic manufacturers begin the scientific and technical process of generic drug development. To receive approval, generic drug applicants must demonstrate that their products are pharmaceutically equivalent and bioequivalent to the reference product.


     4.2.3 Bioequivalence for Novel Delivery Technologies
    Generic products that utilize delivery technologies that go beyond traditional immediate release orally administered tablets and capsules continue to be developed. For some novel delivery technologies, additional work is needed to optimize assessment of bioequivalence.
    Critical path opportunities include:      

    Transdermal Products:  Exploration of new clinical study designs and criteria for evaluation of skin irritation, sensitization potential, and adhesive performance in comparison to the reference product would be useful.

    All the above detail is located here:

    http://www.fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative/CriticalPathOpportunitiesReports/ucm077250.htm


    So I wonder what generic Steve is working for us on?


 
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