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hello group
Please help me to know what are the prerequisits for a BA/ BE Study
for a anti-cancer drug?
Can I conduct a BE study of a anti-cancer drug in healthy volunteers
or it strictly require cancer patients only?
If cancer patient only then what safety parameters I have to consider?
--
Rajendra Dhande.
Head, Clinical Operations.
AnaZeal Analyticals & Research Pvt. Ltd.
Navi-mumbai
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The following message was posted to: PharmPK
Dear Rajendra,
answer to your question obviously depends on the properties of your
your compound. Most of the currently available anticancer drugs are
cytotoxic and hence not suitable to be administered in healthy
volunteers. In those drug substances the kind of safety parameters
depends on the properties as well.
Newer anticancer therapies might be applicable to be tested in
healthy volunteers as well.
Best regards,
Dr. med. Christian Reh
Chief Medical Officer
Pharmacon Research GmbH
Carmerstr. 2, 10623 Berlin
Germany
www.pharmacon.de
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The following message was posted to: PharmPK
Dear Rajendra,
The properties of your drug will decide the prerequisites for your
study.
Assuming that you will be conducting the study as per Indian (CDSCO)
guidelines, it is worth noting what the guidelines state,
"For drugs where the risk of toxicity or side effects is significant,
studies may have to be carried out in patients with the concerned
disease,
but whose disease state is stable."
Moreover, the guidelines also state that,
"The basic design of an in-vivo bioavailability study is determined
by the
following:
i What is the scientific question(s) to be answered.
ii The nature of reference material and the dosage form to be tested.
iii The availability of analytical methods.
iv Benefit-risk ratio considerations in regards to testing in human."
If you know the pharmacological and toxicological profile of your
drug, you
can easily determine the safety parameters you have to consider.
With my best regards,
Rhishikesh Mandke
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