Risk assessment of biopharmaceuticals as a guide for the development of dissolution processes for solid oral dosage forms
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Min Li, PhD, acting chief of Biopharmacy in the Division of Biopharmacy, discusses the scientific and risk-based framework related to the agency's evaluation of the development of in vitro dissolution methods for generic immediate-, extended-, or delayed-release solid oral drug products.
For more information, visit: https://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-2021-lifecycle-generic-drug-04282021-04292021
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FDA CDER's Small Business and Industry Assistance (SBIA) provides training and assistance in understanding the regulatory aspects of human drugs and clinical research.
For more information, visit: https://www.fda.gov/drugs/news-events-human-drugs/generic-drugs-forum-2021-lifecycle-generic-drug-04282021-04292021
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FDA CDER's Small Business and Industry Assistance (SBIA) provides training and assistance in understanding the regulatory aspects of human drugs and clinical research.
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