PharmPK Discussion - Assay limits and precision of ligand-binding assays

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On 27 Feb 2002 at 11:56:07, McBurneA.-a-.ukorg.huntingdon.com sent the message


The following message was posted to: PharmPK

Please could anyone help on this topic? I am aware that there was some
discussion back in February but would really appreciate some more
information on this.

It has been suggested that the assay limits and precision of
ligand-binding assays should be as stringent as those for small
molecules ie 15-20% CV. It has also been stated that this matter has
been discussed by the FDA and EMEA and agreement reached that there
should be no relaxation of the criteria for large molecules to 30%CV.

Please could someone provide me with a reference to any meetings the FDA
and EMEA may have held on this subject?

On a similar topic, could anyone tell me if there is a general consensus
on the use of "significant figures" for reporting analytical data and PK
parameters?

Thanks

Alan

HUNTINGDON LIFE.SCIENCES LIMITED

http://www.huntingdon.com

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