Bioequivalence and Bioavailability Forum

Dear vishal,

Replicate study designs are recommended for BE studies of modified-release dosage forms and highly variable drug products (within-subject coefficient of variation ≥30%), including those that are immediate release, modified-release, and other orally administered drug products.

Please refer attached link of FDA guidelines.
http://www.fda.gov/cder/guidance/3616fnl.pdf http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf

Regards,

Shankar NJ

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I edited your post removing UTF-16 (2 Byte Unicodes) from the text.
Please use the Preview before posting. [HS]

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Edit: Link corrected for FDA’s new site. [Helmut]