FDA offers new bioequivalence study guidance for 31 generic drug ingredients

FDA has put together a new advisory to help generic drug makers deliver their products to the market more quickly. Focusing on various active pharmaceutical ingredients (APIs), the draft recommendations point to the most appropriate types of bioequivalence studies that may need to be done for abbreviated new drug application approval. “The selection of the method used to demonstrate bioequivalence depends upon the purpose for the study, the analytical methods available, and the nature of the drug product,” according to FDA.