Formulation and Delivery
Robert Lionberger, PhD
Director, Office of Research Standards, Office of Generic Drugs
U.S. Food & Drug Administration
Silver Spring, Maryland
Yan Wang, PhD (she/her/hers)
Lead Pharmacologist
U.S. Food and Drug Administration
Silver Spring, Maryland
You might think that generic drugs are copies and what CDER's Office of Generic Drugs does is simple. CDER’s new drug programs have the gold standard in clinical trials, but they can be so powerful for decision making that we don’t need to know why a drug works. But for an abbreviated program like the generic program, we have to use pharmaceutical science and clinical pharmacology to identify what needs to be the same so we do not have to repeat clinical trials to provide access to competition. We make bioequivalence studies for simple products more efficient, but we spend significant efforts on establishing the possibility of generic competition for complex products (inhalation, dermal, long-acting injectable or drug-device combination products). We coordinate lab research to characterize complex products and build models to describe and predict what they do. Advancing the science of generic drugs has created new knowledge at the interface of formulation science and clinical pharmacology that is valuable for all drug development.