Requirements for Regulatory Bioequivalence
The bioequivalence for oral drug is decided in contrast the relative bioavailability of the emblem drug compared to the drug. Food impact bioavailability area unit ordinarily conducted for brand spanking new medication and drug impact throughout the investigational new drug (IND) part to assess the results of food on the speed and proportions of engrossment of a drug once the drug product is management shortly when a meal fed conditions, as compared to commanding underneath diet conditions.
- WHO Approaches
- FDA Approach and regulations
- TGA and risk management approach
- Food-Effect Bioavailability and Fed Bioequivalence Studies
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