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Dear All,
I am not sure sure that for bioequivalence study of generic drug, do
we classify the BE study as Phase 1 Clinical study. In my opinion, I
think it should be classified as Phase 4 study because the drug that
we test is not the new molecular entity.
Is anyone can give me the comments.
Wichittra
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The following message was posted to: PharmPK
Dear Wichittra
As BE studies are conducted on healthy volunteers and usually the
objective is equivalence & pharmacokinetics, it falls under Phase I
category.
While Phase IV trials also known as post marketing surveillance trail
involve the safety surveillance (pharmacovigilance) and ongoing
technical support of a drug after it receives permission to be sold.
The Phase IV trial is designed to detect any rare or long-term adverse
effects over a much larger patient population and longer time period
than was possible during the Phase I-III clinical trials. Thus any
harmful effects discovered by Phase IV trials may result in a drug
being no longer sold, or restricted to certain uses.For these reasons,
BE study can not be categorised under Phase IV trial.
Thanks
Dr Sajjad A Desai
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Dear Sajjad/David
I have understood from the conversation that BE study comes under
"Phase I" and have observed such associations before as well. However,
I think BE studies should not be classified as Phase I - since the
intent is altogether different: e.g., in phase I there is a new drug
whereas in BE there is a new formulation PLUS comparator (reference
drug). I do understand that the intent of both BE and Phase I includes
PK, but the overall design, presence of reference drug, etc makes such
a trial very unique. Should this still go into Phase I category? Or
should BE be kept separate and distinct?
I always had this doubt in my mind - Your thoughts please!
Dr. Gagandeep Singh
Sr. Consultant - Lifesciences; Cognizant Tech. Solns
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The following message was posted to: PharmPK
Dear Gagandeep
Under Phase I clincial trial, you will find different types of studies
like single ascending dose, multiple ascending dose, bioavailability,
food interaction, drug-drug interaction etc., which are generally done
on healthy volunteers and it is well known that mainly Phase I
clinical trial deals with NCE. But as BE studies are conducted on
healthy volunteers, in my opinion it is one of the Phase I type
studies as mentioned above.
Thanking you
Dr Sajjad A Desai
Assistant Medical Director
Serum Institute of India
212/2, Hadapsar, Pune. 411028
India.
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Hi
I agree that BE studies in general are different from Phase I studies,
except when some formulation development BA or BE studies are taken up
as part of the Clinical Development program of a new drug/ NCE, when
they become part of the (late) Phase I development.
The BA studies conducted during clinical development program of
modified release formulations of the traditional formulation of
marketed drugs are different from both the above and have flavor of
both.
Regards,
Pankaj
--
Dr Pankaj Goyal, MD
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