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Re: Splitting pills. Reliable or not? (@Ed and others)

Posted by ed_uk2010 on January 17, 2015, at 17:03:17

In reply to Re: Splitting pills. Reliable or not? (@Ed and others) » ed_uk2010, posted by europerep on January 17, 2015, at 15:15:08

>I wouldn't be surprised if even "real" (i.e. non-manipulated) tablets would show some variation in the microgram level that are not noticeable by the patient.

There will always be variation - no quantity can ever be exact. What's important is whether or not the differences are clinically relevant.

For pharmaceuticals, regulations are set out in the European Pharmacopoeia, the United States Pharmacopeia etc.

The rules are listed under the heading 'Uniformity of Dosage Units'. The decision to accept or reject a batch is based on a *statistical calculation*. This is because it's not possible to analyse every tablet..... the tablets are destroyed during the analytical/assay process.

http://www.google.co.uk/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0CC4QFjAC&url=http%3A%2F%2Fwww.usp.org%2Fsites%2Fdefault%2Ffiles%2Fusp_pdf%2FEN%2FUSPNF%2F2011-02-25905UNIFORMITYOFDOSAGEUNITS.pdf&ei=ueO6VKazJMLzaoS3gvAB&usg=AFQjCNFtbrH3DD9mVBCvE3fJOFq4ZICKEA&sig2=7wYdO5zbunl1oFxpsjZK5Q

 

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poster:ed_uk2010 thread:1075154
URL: http://www.dr-bob.org/babble/20150102/msgs/1075198.html