It’s better to ask Todd or Joe, but yes I believ
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Drug Substance Requirements for INDs
• Description and characterization
• Manufacturer(name,address,contact
information)
• Generalmethodofpreparation/synthesis
• Specification(tests,analyticalproceduresand acceptance criteria)
• Batchanalysisdataforclinicaltrialbatch
• Stability(throughendofclinicaltrial)
https://www.fda.gov/media/84917/download
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