Regulatory Requirements for Bioequivalence

The bioequivalence for oral drug is determined by contrast the relative bioavailability of the logo drug compared to the generic drug. Food effect bioavailability are commonly conducted for new drugs and drug effect during the investigational new  drug (IND) phase to assess the effects of food on the rate and proportions of engrossment of a drug when the drug product is management shortly after a meal fed conditions, as compared to commanding under diet conditions

  • WHO Approaches
  • FDA Approach and regulations
  • TGA and risk management approach
  • Food-Effect Bioavailability and Fed Bioequivalence Studies
  • European Guidelines

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