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Dear all,
I would like to know is there any reuirement for doing bioequivalence
study of Parenterals. is there any guideline to do so.
Regards,
Jayanti
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Hi Jayanti
As such there is no BE if the parenteral product is a true solution,
however, there are other issues that need to be addressed with
liposomal or liposome like parenteral products (e.g. nanoparticles,
peptides etc.). FDA has a guidance that is based for liposome products.
You could visit that at http://www.fda.gov/cder/guidance/2191dft.pdf .
Hope this helps.
Manish Issar Ph.D
Biopharmaceutics Department
Sandoz (Formerly Eon Labs Inc.),
4700 Sandoz Drive
Wilson, NC 27893, USA
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