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Dear Sir
We would like to know any direct extrapolation for conversion of dose
required for IV admisitation from the Cmax, Tmax and AUC available for
the drug administered by IM
Kindly help
Regards
kurani
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Dear Kurani,
Are you talking about a pre-clinical trial (mice)? Could you make us a
context for focusing better the question please?
Best regards
Sergio SB
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Dear Dr Segio,
Many thanks for your kind reply
1. In the preclinical animal model..... suppose we have AUC, Cmax
and Tmax for X drug and is administered by IM route, can we extrapolate
IV dose from the same?
2. Can we employ same IM to IV dose calculation tool for
extrapolation of dose in humans?
Please suggest,
kurani
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The following message was posted to: PharmPK
With IM dose, drug has to be absorbed from the muscle mass to the systemic
circulation while with the IV dose the drug is administered directly to
the
systemic circulation. Therefore the rate and extent of systemic availability
with IM and IV doses may not be the same.
You can not interchange the IV dose to IM dose and vice versa. You will
have to
determine the bioavailability of the IM dose relative to IV dose before
making
any estimates of the interchangeable doses.
Hope this helps.
Aziz Karim
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Dear Dr. Kurani,
Regarding with the first question I'd like to say that you can extrapolate the
IM dose to IV one, assuming the probable toxicity (it depends of the
physical-chemical active principle's properties as well as the formulation
used). If you want to plan an IV study to check up absolute bioavailavility, you
should use the same dose than the IM study.
About the question #2 , Two useful articles which can help you on
calculation the Human Equivalent Dose (HED).
[Sharma, V and McNeill JH, 2009 Brit J Pharmacol., 157, 907-921
Reagan-Shaw S., et al., 2007 FASEB J, 22, 659-661 - db]
All the best ! and Good luck
Sergio SB
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