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I appreciate if any of the FDA insiders provide me an answer my
question below:
As Part of ANDA submissions we are writing study reports for individual
studies of the project. Do we absolutely follow ICH Study report
format outlined in the ICH Guidance ICH E3 issued in 1996? My reading
of the guidance indicates that this study report is targeted for Phase
I-III studies of NDA requiring lot of details on safety, clinical
chemistry, patient demographics which are of limited value in the
context of ANDA and the PK information is buried in between all this
redundant information. In ANDA pharmacokinetics and BE statistics are
critical and I am afraid ICH guidance doesn't address this important
segment of study reports for generics.
Your input is highly appreciated.
Prasad
Prasad NV Tata, M.Pharm., Ph.D.
Mallinckrodt, Inc.
675 McDonnell Blvd.
Saint Louis, MO 63134
Tel: (314) 654-5325
Fax: (314) 654-9325
e-mail: prasad.tata.-a-.tycohealthcare.com
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The following message was posted to: PharmPK
Dear Mr.Prasad,
A bioequivalence study will cover all the table of contents of ICH E3
guidance for industry, the patient is a subject for an ANDA submission
it
is required to submit subject demographic data and in individual and
statistical sections it will cover the PK and stats of B.E study.
With Regards,
V.Radhakrishna
Clinical Pharmacology and Pharmacokinetics
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Dear Mr. Radhakrishna,
I do not agree with your response to the initial question.
I agree 100% with Tata's message.
While I understand the need for standards and uniformity, I strongly
believe that the ICH template tailored for the submission of clinical
trial results is inadequate for the ANDA submissions.
It is absolutely true that the most relevant information of BE
study(studies) is scattered and illogically organized in the ICH
template.
Furthermore, there are numerous sections left blank (with N/A) within
the main body of the report while critical information is relegated to
Appendices.
I joint Tata in requesting some comments from the actual reviewers.
radu
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