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The following message was posted to: PharmPK
Dear e-Druggers,
I need to understand the regulatory requirement for Conducting BE
Study of
combipack product.
Case Example:
I have Generic Product X having BE study against the Innovator
I have Generic Product Y having BE study against the Innovator
I want to file the registration dossier for a co-packed presentation
of X &
Y under brand name Z. Do I need to have a fresh BE Study for this pack.
I understand that if I offer a Fixed dose combination of X & Y under
brand
name Z, I have to conduct BE Study against individual innovator
product and
may be I have to conduct clinical trial as well.
Thanks,
Rakesh Chaurasia
Mumbai-India
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The following message was posted to: PharmPK
Dear Rakesh,
You have to conduct a BE study to support both the efficacy and
safety in combination against the individual drug products if they
are co-prescribed for better efficacy. (No drug interaction)
If the innovator product is not available than you have demonstrate
both efficacy and safety of that fixed dose combination or you may
have to conduct a clinical trial if they are not co-prescribed but
have potential of combination product.
If it is merely a patient compliance factor and does not involve any
change in labeling and dose administration you may not require a BE
study or even a clinical study.You may also refer Schedule "Y"
Thanks
MKV
Mumbai
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