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Dear All:
=A0
Are there any published work on Bioequivalence studies of Oncology
drugs?=A0 I am particularly looking for patient/subject recruitment
methodology, BE strategy (parallel Vs Cross over, individual Vs Average
BE etc) and centers known to conduct this kind of studies.
=A0
Any leads?????
=A0
Prasad
Prasad NV Tata, M.Pharm., Ph.D., FCP
Saint Louis, MO 63134
Tel: (314) 654-5325
Fax: (314) 654-9325
e-mail: prasad.tata.-at-.tycohealthcare.com
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From: "Labadie, Robert"
The following message was posted to: PharmPK
Hi Prasad,
I've done one oncology BE. We ran it in healthy volunteers and crossover
design similar to other compounds for internal decision making, Phase 1
supply to Phase 3 supply.
Regards.
Rob
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The following message was posted to: PharmPK
Dear Prasad:
There are several BE studies were conducted with
Taxol; google it and should find some good hints. MD
Anderson in Texas is one option. I know several
oncologist there. Let me know if you need more info.
Rostam
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Dear Colleagues:
The following message appeared in today's PharmPK listserver, and what
amazed me was the statement that an oncology drug was tested in healthy
volunteers. Could you clarify whether testing agents that presumed to be
cytotoxic in healthy volunteers is:
a. Allowed by FDA regulations?
b. Is considered ethical?
My understanding is that it is neither allowed nor ethical, and
therefore the statement below amazes me. My understanding was that while
Phase I trials are normally conducted in healthy volunteers, there is an
exception for drugs with predictable toxic effects, such as anti-cancer
drugs, which cannot be tested in healthy subjects. Please advise me if
what I have been telling my students for years is incorrect.
>PharmPK - Discussions about Pharmacokinetics
> Pharmacodynamics and related topics
>
>From: Name deleted
>
>The following message was posted to: PharmPK
>
>Hi Prasad,
>
>I've done one oncology BE. We ran it in healthy volunteers and crossover
design similar to other compounds for internal decision making, Phase 1
supply to Phase 3 supply.
>
--
Professor Walter Wolf, Ph.D.
President, Correlative Imaging Council, Society of Nuclear Medicine
Distinguished Professor of Pharmaceutical Sciences
Director, Pharmacokinetic Imaging Program
Department of Pharmaceutical Sciences, School of Pharmacy
University of Southern California
1985 Zonal Ave., Los Angeles, CA 90089-9121
E-Mail: wwolfw.aaa.usc.edu
Telephone: 323-442-1405
Fax: 323-442-9804
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Dear Prof. Wolf,
Actually, as a concept, you are 100% correct. Having said that, there are
exceptions, due to the existance of some rationally-designed target-based
anticancer drugs that are known to be much better tolerated and safe. In
these very few cases where subjects safety is guaranteed, it is ethical
and FDA-allowed to test these drugs in healthy persons. They are usually
single-dose or very short-course treatment clinical trials, mainly to see
PK characteristics. Three examples are gefitinib, erlotinib (both are
Epidermal Growth Factor Receptor inhibitors, active in patients with lung
cancer, with potential side effects being skin rash and mild
nausea/diarrhea, mainly with repeated dosing), and all-transretinoic acid
(active in a very unfrequent type of leukemia, which is very similar to a
frequently prescrubed anti-acne and anti-sundamage medication
-9cisretinoic acid-). Please find below some quick references of clinical
trials of these drugs in healthy persons.
http://www.asco.org/ac/1,1003,_12-002636-00_18-0023-00_19-00101630,00.asp
http://www.asco.org/ac/1,1003,_12-002636-00_18-0016-00_19-002172,00.asp
http://www.academyccm.org/PharmaFacts/PharmaFacts_V_6_N_1/pharmafacts_v_6_n_1.html
http://www.fda.gov/ohrms/dockets/ac/02/briefing/3894B1_01_AstraZeneca.pdf
I hope this is helpful,
Best regards,
Emiliano
Emiliano Calvo, MD PhD
The Institute for Drug Development
Cancer Therapy and Research Center
San Antonio, Texas
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The following message was posted to: PharmPK
I am coordinating an event that examines the evolving paradigm for
oncology drug development to be hosted Sept. 26-27, 2005 in Philadelphia,
PA. The event will address this as well as other issues raised in this
forum. If you're interested in more info., contact me directly. [Note
directly at Justin.Browne.aaa.parexel.com thanks ;-) - db]
Justin Browne
410-796-7405
justin.browne.aaa.parexel.com
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There is no categorical exclusion.
In the past, alkylating agents and similar drugs were mutagenic and
carcinogenic, so the risk was too high for healthy volunteers. Many other
anticancer drugs do not have sufficient safety information at early stages
to consider testing in healthy volunteers. However, today's range of
compounds includes some with full safety profiles, and the IRB and FDA
reviewers can conclude in some cases that the studies are safe in healthy
volunteers, particularly single-dose studies when chronic safety data are
already available.
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