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Dear,
I would like to know if are there pharmacokinetics or bioequivalencies
studies, in humans, with long half-life for Ivermectin tablets?
The half-life described in Micromedex is 18 hours. However, the maximum
half-life described in Korolkovas is 56 hours. Is it the maximum or are
there more data upper 56 h?
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The following message was posted to: PharmPK
Dear Mauricio
In this case you can refer to innovater's NDA submitted to FDA. I
believe that most accurate estimation is near to 18 hr (range: 16-22
hr).
There may be some outliers when half lives can be more than that of
estimated population half-life. A general approach used in these cases
is to use maximum stretched washout period based on half life.
Please refer to
CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVAL PACKAGE for: Ivermectin
APPLICATION NUMBER: 050742
I accept the correction from group if I have missed somrthing.
Kind Regards
[Try http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory#apphist
- db]
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Dear Mr.Mauricio,
Kindly go through the following article which gives you the details
regarding Half life of Ivermectin tabelts.
Aranzazu Gonzalez Canga, Ana M. Sahagun Prieto, M. Jose Diez Liebana,
Nelida Fernandez Martinez, Matilde Sierra Vega, and Juan J. Garcia
Vieitez. The Pharmacokinetics and Interactions of Ivermectin in Humans--A
Mini-review. AAPS J. 2008 March; 10(1): 42-46. Published online 2008
January 25. doi: 10.1208/s12248-007-9000-9
The full article can be accessed from the following link
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2751445/
Regards,
Dr.S.Gunasakaran, MD
Head - Clinical Research & Medical Affairs,
Azidus Laboratories Ltd, CRO.
Clinical Research Forum http://www.clinicalresearchsociety.org/forum/
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