Asian Pacific Journal of Health Sciences

Yazarlar: Eshant Duggal, Pankaj Kashyap, Ramandeep Singh, Satinder Kakar

Konular:-

DOI:10.21276/apjhs.2014.1.1.2

Anahtar Kelimeler:505(b)(2) NDA,Hybrid applications,Reference listed drug,Clinical studies,Generic drugs,Biowaivers,Market exclusivity

Özet: Drug development is a challenging way to make profits. Thousands of once-promising compounds wash out in the preclinical phase and hundreds more fail in clinical trials and only one is likely to be approved for marketing. Hundreds of millions of dollars are spent on pharmaceuticals or biologics that fail to make it to market. The successful to reach here the market, developed in this way takes approximately 12-15 years. However, there are alternatives to spending enormous sums in developing drugs. One of the approach is to concentrate on developing products for niche markets that may have smaller market potential, but that can be approached with dramatically lower development costs and time using section 505(b)(2) pathway to FDA approval. The second approach is the request for biowaivers i.e. in vivo bioequivalence and bioavailability study waivers in accordance to the principles of the Biopharmaceutical Classification System (BCS) that can significantly save time and cost. Third one is the generic drug approval pathway in which only BA/BE studies are done comparing the proposed product to the innovator product. The present review apart from giving a brief overview of the above approaches highlights the present status and future prospective of these approaches. It also gives a brief overview of impact of these fast track approval procedures on the global market of medicines.

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