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Another reason why P&G are onto OBJ, page-7

  1. 5,330 Posts.
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    Hi Martin,


    $1.5b for a new toothpaste compound sounds false to me. He has been known to exaggerate before.



    The Association of British Pharmaceutical Industry figure is estimated to be £1.15b - this converts to USD$1.8b, or AUD$2.2b




    FDA regulates toothpastes as drugs or cosmetics, depending on their ingredients and purpose. Toothpastes are drugs if they contain fluoride, are intended to prevent or lessen diseases like tooth decay, or affect the structure of the body or how it functions. Toothpastes that do not contain fluoride and that claim only to cleanse teeth are considered cosmetics.
    Source


    The Association of British Pharmaceutical Industry estimates it costs £1.15bn on average to get a drug to market. That is in line with what most academics have estimated, including the Office of Health Economics.
    Source


    Due to the high cost involved in the development of a new toothpaste or cancer drug the world's largest Pharmaceutical companies like GSK will often use surrogate endpoints.


    GSK Medicine: Sodium fluoride Dentifrice
    Study Number: RH01299
    Title: The Effect of Fluoride in an Experimental Dentifrice on Remineralization of Erosive Lesions In-Situ


    Rationale: Fluoride containing dentifrices were effective in reducing dental caries. Due to the high cost involved in conducting clinical caries trials, surrogate measures to determine fluoride efficacy were introduced. The In-situ model is one among the surrogate measures of fluoride efficacy. The aim of the study was to demonstrate a dose-response to sodium fluoride (NaF) concentration, across the range 0 parts per million (ppm) to 1426 ppm F, in the ability of an experimental dentifrice formulation to remineralize eroded enamel in situ, measured via surface microhardness recovery (SMHR). Enamel fluoride uptake (EFU) was also determined using the microdrill enamel biopsy technique.

    gsk clinical caries.JPG
    Last edited by abdm: 18/12/14
 
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