Generic pharmaceutical products application

Abstract This chapter reviews emerging techniques for deep, non-invasive Raman spectroscopy of diffusely scattering media. As generic analytical tools, these methods pave the way for a host of new applications including non-invasive disease diagnosis, chemical identification and characterisation of pharmaceutical products. 

The generic manufacturer may not submit an ANDA for the new pharmaceutical form until 11.5 years after approval of the original product (i.e. 5 years from the date of approval of the new form + 0.5 years for the paediatric application). 

Dissolution tests are used nowadays in the pharmaceutical industry in a wide variety of applications to help identify which formulations will produce the best results in the clinic, to release products to the market, to verify batch-to-batch reproducibility, and to help identify whether changes made to formulations or their manufacturing procedure after marketing approval are likely to affect the performance in the clinic. Further, dissolution tests can sometimes be implemented to help determine whether a generic version of the medicine can be approved or not. 

These regulations were challenged in Mova V. Shalala, a case involving the brand-name drug product Glynase. Mova Pharmaceuticals was the first generic applicant for Glynase. Pharmacia ... 

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