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I am very much interested in knowing about Clinical trials. I have
very little knowledge about CT. I am waiting for your valuable answers.
1) What is BA/BE studies, Why it is conducted, what is its main goals
to conduct BA/BE.
2) Bioavailability and bioequivalence studies that occupied a major
share in the clinical research market, WHY?
3) Pilot study Vs Pivotal study?
4) Is all BA/BE study is submitted to regulatory authorities?
5) How confident interval used in BA/BE studies?
Email: gomes.-at-.aol.in, rulargomes.aaa.gmail.com
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YOU MAY GET ANSWERS FOR YOUR FIRST 3 QUESTIONS FROM YOUR ORGANISATION
CIRCLE , ITS MY ANSWERS TO YOUR 4TH QUESTIONS , I HOPE IT WILL GIVES
YOU ALL EXPLANATION
Obtaining regulator's nod for BA/BE studies:
The Drugs Controller General of India (DCG (I)) is the Regulatory
Authority who grants permission for the conduct of clinical studies
on human volunteers. This is in accordance with Rule 122-DA of Drugs
and Cosmetic Rules, which states that no clinical trial for a new
drug, whether for clinical investigation or any clinical experiment
by any institution, shall be conducted except under, and in
accordance with, the permission, in writing, of licensing authority.
Is it mandatory to obtain DCGI permission to conduct Bioavailability
and Bioequivalence (BA/BE) studies?
To answer this, let us have a closer look of the Law. Rule 122-DA
clearly states that clinical trials are not allowed on new drugs
without permission from DCG (I). So now, we need to look at the
definitions of 'Clinical trials' and 'new drugs'.
The Rule 122-DAA of the Drugs And Cosmetics Rules defines clinical
trials as a systematic study of new drug(s) in human subject(s) to
generate data for discovering and/or verifying the clinical,
pharmacological (including pharmacodynamic and pharmacokinetic) and/
or adverse effects with the objective of determining safety and / or
efficacy of the new drug." The Bioavailability and Bioequivalence (BA/
BE) studies fall within the purview of the definition of clinical
trials as BA/BE studies involve verifying the pharmacokinetic
effects. Hence it is required to obtain permission from DCG (I) to
conduct BA/BE studies.
Now the next question would be whether all studies require DCG (I)
permission. The answer is not all studies require permission but only
those studies which are conducted with new drugs.
The Rule 122-E of Drugs and Cosmetics Rules gives the definition of
new drug, according to which the following will be a new drug:
o a drug which has not been used in India to any significant extent
and not been recognized as effective and safe in India.
o a drug already approved in India which is now proposed to be
marketed with modified or new claims, namely, indications, dosage,
dosage form (including sustained release dosage form) and route of
o a fixed dose combination of two or more drugs, which are now
proposed to be combined for the first time in a fixed ratio, or if
the ratio of ingredients in an already marketed combination is
proposed to be changed.
Under the same rule, it is also explained that a new drug shall
continue to be considered as new drug for a period of four years from
the date of its first approval or its inclusion in the Indian
Pharmacopoeia, whichever is earlier. To comply with this rule, before
conducting a clinical trial, a sponsor or a CRO is required to verify
the status of the drug. A list of approved drugs is provided by the
Central Drugs Control Standard Organization. There are inherent
problems with this list. This list is not exhaustive as the date of
first approval is only from the year 1999. This does not address the
approval of drugs prior to 1999 and also does not mention the
complete name of the drug up to 2003. This does little to help in the
decision making process of adjudging the status of a drug,
particularly in the case of bioequivalence studies.
A case may be made for the waiver of permission for the 'new drugs'
in this four years period. i.e., which have been approved for
marketing but not completed four years post approval.
These products will be used only in clinical studies on small number
of volunteers and will not involve thousands of patients as is case
with marketing of the product, where the safety of the drug may
perhaps be a concern in the first four years as our country might not
have had any experience with that particular new drug. In
bioequivalence studies, the drugs are always given under very
controlled conditions and under complete supervision of the clinical
investigators who are medically qualified doctors who can monitor the
study subjects very closely and as per the protocol approved by the
competent ethics committee close supervision and monitoring in a non
clinical trial setting is not possible and hence may be of concern to
the regulatory authority.
What would this grant of waiver imply?
This would mean that drugs that have been granted approval by the DCG
(I) in the last 4 years need not go through a re-approval process if
a bioequivalence study is required on them . This would save an
enormous amount of time and resource for both the industry and the
WELLQUEST CLINICAL RESEARCH
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The following message was posted to: PharmPK
in the following at least some answers ;-)
> 1) What is BA/BE studies, Why it is conducted, what is its main goals
> to conduct BA/BE.
> 3) Pilot study Vs Pivotal study?
> 4) Is all BA/BE study is submitted to regulatory authorities?
No, only the ones you will need for regulatory approval.
You will not necesarrily need to show studies performed in product
But in almost al legislations you will have to get an approval of you
> 5) How confident interval used in BA/BE studies?
See answer to question #1.
Ing. Helmut Schuetz
BEBAC - Consultancy Services for
Bioequivalence and Bioavailability Studies
1070 Vienna, Austria
tel/fax +43 1 2311746
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