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Dear Group members,
Can any one give me following help.
What is microdosing?
Any regulatory guidance for Microdosing available?
Any good articles related to microdosing are available? Please give
me links
I hope, I will get good reply.
regards
Dr. Ilesh
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The following message was posted to: PharmPK
Hello Dr Ilesh,
> What is microdosing?
A microdose is defined as less than 1/100th of the dose of a test
substance calculated (based on animal data) to yield a pharmacologic
effect of the test substance with a maximum dose of <= 100micrograms.
Microdosing offers the advantage of requiring significantly less pre-
clinical safety data than a therapeutic dose Phase I study.
Accelerator Mass Spectrometry (AMS) is an enabling technology for
these types of studies.
> Any regulatory guidance for Microdosing available?
We have links to the EMEA and FDA regulatory papers on our website:
http://www.vitaleascience.com/regulatory.htm
> Any good articles related to microdosing are available? Please give
> me links
Check out this link on our website, there are several excellent
articles on microdosing and AMS applications:
http://www.vitaleascience.com/literature.htm
Feel free to contact me if you would like any more information!
Regards,
Brian Faulkner
Senior Scientist
Vitalea Science, Inc
phone: 530.669.1457
FAX 530.669.1457
www.vitaleascience.com
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Hi Dr.Ilesh,
A microdosing study comprises of adminsitering sub therapeutic doses
of investigational drugs to obtain date on safety and PK profile of
the drug. As per EMEA position paper, a microdose is defined as less
than 1/100th of the dose calculated to yield a pharmacological effect
of the test substance based on the primary pharmacodynamic data
obtained invitro and invivo ( with doses below microgram level) and
not exceeding 100 microgram. It is a pre phase I study.
Following guidlines will be helpful.
EMEA
http://www.emea.eu.int/pdfs/human/swp/259902en.pdf
USFDA (Exploratory IND guideline)
http://www.fda.gov/cder/guidance/7086fnl.pdf
Regards
Ganesh
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Hi Ganesh,
I'd be interested to know what safety information you can obtain from
giving in effect a homeopathic dose.
Cheers
Alex
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The following message was posted to: PharmPK
Dear Dr. Ilesh:
Please also look at the following website for more
info on microdosing.
http://www.nc3rs.org.uk/news.asp?id=193
Rostam
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HI alex,
Thanks for correcting me. Microdosing studies can be used only for
deriving pharmacokinetic profile of the drug, and not safety.
Regards
Ganesh
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The following message was posted to: PharmPK
What you get from a human Phase 0 microdose study is human
metabolite, ADME and PK data. With this information you can select
the appropriate animal model to conduct your tox studies. Too many
times one finds human specific metabolism and as a result the tox
needs to be redone as the animal model selected did not produce these
metabolites (see Lappin G and Garner R C (2003) Big physics, small
doses: the use of AMS and PET in human microdosing of development
drugs. Nature Reviews - Drug Discovery, 2, 233-240.
Professor Colin Garner BPharm PhD DSc FRCPath
Chief Executive Officer
--
Xceleron Ltd
York Biocentre
Innovation Way
Heslington
York YO10 5NY
United Kingdom
Switchboard: +44(0)1904 561561
Direct line: +44(0)1904 561568
FAX: +44(0)1904 561560
Email: colin.garner.aaa.xceleron.com
http://www.xceleron.com
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