[Toxicology] Re: How to decide in vivo and in vitro drug concentrations for preclinical toxicology?

Prabhu india dprabhu at orchidpharma.com
Wed Aug 3 00:44:12 EST 2005


Hai wills,

I saw your question on the forum regarding the selection of doses in
drug discovery and development.  Normally, DDD is carried out by pharma
companies.  Once the lead molecule is identified they give for testing
to the toxicology group.  For any drug to be filed for regulatory
reasons it should adhere to certain guidance documents framed by the
FDA (Food Drug and Administration).  The FDA had clearly given the
protocols for carrying out the studies in animals and mammalian cells.
The development group should generate the data out of the procedures
mentioned in document.

In case of an acute oral toxicity study, the maximum recommended dose
is 2000mg/kg b.wt.  In mammalian cells, the dose is 5mg/ml or
5mg/plate.  Depending upon the toxicity profile of the drug in these
tests the doses may go down or even get dropped sometime.  There are in
fact procedures which correlates the in vitro data to determine the
starting dose for in vivo studies.  They are not much reliable.  For
DDD there are well defined guidelines and pharma companies across the
world strictly follow them and proceed in phase wise manner.

I hope the information meet your need.  Any questions, please feel free
to contact me anytime without any hesitation.

By the way I am Dr. D. Prabhu working as a research scientist in one of
the fast growing pharma company in India.  I am currently Head  for
Genetic toxicology division.  I am more interested to participate in
your questionnaires.


regards,
D. Prabhu, Ph.D.,
Research Scientist - I
Orchid chemicals and pharmaceuticals ltd.
476/14, Old Mahabalipuram Road
Sholinganallur
Chennai - 600 119 (TN), India
Tel: 91-44-24501474 Extn: 236
Cell: 09840715628
Fax:91-44-24501396 
Email: dprabhu at orchidpharma.com



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