PharmPK Discussion - BE study with non RLD strength

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On 28 Jul 2007 at 19:24:14, "sukhbir singh" (sukhbir83.aaa.gmail.com) sent the message


[Sorry about the double post but this one probably has a better
subject - db]

The following message was posted to: PharmPK

Dear Friends,

It's really good to hear from all of you regarding various issues. I
have one more query to add upon.

The innovator's drug is available in two strengths 1 mg and 5 mg but
only the 5 mg strength is mentioned as RLD in "Orange Book" by USFDA.

Can we conduct bioequivalence study of our 1 mg generic product vs. 1
mg of innovator's product (instead of 5 capsules of our 1 mg generic
vs. 1 capsule of 5 mg innovator's product)?

Our 1 mg and 5 mg generic products are not proportionally similar to
each other with respect to weight. Is there any specific guideline or
case study (accepted by USFDA) on this issue?

Hope for an early response.

Regards,

Sukhbir Singh

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