Dear all,
Good morning. Our CMC team is changing an existing IV formulation. They are switching from a free base formulation of 10 mg/vial (5 mg/mL) to the hydrochloride salt formulation of 45 mg/vial (15 mg/mL). So the question is what type of study will we need to switch patients from old formulation to the new formulation. Since both are IV formulations, probably a BE study won't work.
What is the regulatory impact? My assessment is that at a minimum, we will need to file an IND Amendment with full CMC information.
Please get back to me at your earliest convenience.
Thanks and Regards,
Ani
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Aniruddha Railkar
Director, CMC Regulatory Affairs
Rockville MD
United States
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