*Applications will be reviewed on a rolling-basis.
A research opportunity is available in the Office of Pharmaceutical Quality/ Office of New Drug Products (ONDP), Center for Drug Evaluation and Research (CDER), Food and Drug Administration (FDA) in Silver Spring, Maryland.
The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs. This work covers more than just medicines.
The project requires a detailed assessment of the stability data from all approved breakthrough therapy New Drug Applications (NDAs). This analysis will not only provide confirmation that no allowances beyond the International Conference for Harmonisation (ICH) Q1 guidance’s were permitted for these breakthrough therapies, but also to provide inputs for post-hoc analysis using alternative approaches to stability assessment.
Under the guidance of the mentor, the participant will learn to perform data mining of stability data contained in breakthrough therapy NDAs that will inform the development of alternative approaches to stability assessment. In addition, the participant will collect samples from breakthrough therapy NDAs, perform hyper accelerated stability studies, and validate stability modeling software outputs with long term stability results from the NDA.
If you have questions, send an email to ORISE.FDA.CDER@orau.org. Please include the reference code for this opportunity in your email.