Saturday 28 January 2012

Why Generic Drugs are termed "Abbreviated"?

 

 
 
Why Generic Drugs are termed "Abbreviated"?
 
 
 

 Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug.

For  articles related to ANDA Filing, log on to pharmatreasures.blogspot.com




at

2 comments:

  1. RK CLOTHING DESIGNS1 March 2012 at 12:07

    very well made
    it .All information on this site is represented
    paroxetine

    ReplyDelete
  2. Unknown15 March 2017 at 10:44

    In time of material charging material was dropped down into floor and some amount of material charged into reactor then we dont no how much charged and how much loss then what is the corretive action taken for this issue
    Incase of solid & sovlents plesae tell me

    Raju-QA

    ReplyDelete