Human Factors Studies

If you were manufacturing a generic of a combination product already on the market, then is human factors data required to be submitted to the Agency?

The combination of generic drugs in a product- Requirements of Bioequivalence studies or clinical trials on humans will depend upon the following aspects,

  • If the amount of active generic drugs is different than the existing marketed generic drugs
    -If the combination is new (for the first time to be sold in the market)
  • If some new excipient is used in the combination generic product
  • If some new indication is claimed for the fixed combination
  • Regulatory requirements of the country in which it will be sold as a ‘Fixed dose combination’