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Hi,
Could anyone please provide the batch size requirements for both new
drugs as well as generics. I think this might be the standard below,
but I am unsure. I could not find anything in the Oct 2000 guideline
for oral drugs. Please advise.
"The test batch or lot should be manufactured under production
conditions and should be at least 10% of the size of the largest lot
planned for full production, or a minimum of 100,000 units, whichever
is larger."
Harold Boxenbaum, Ph.D.
Pharmacokinetic Consultant
Arishel Inc.
14621 Settlers Landing Way
North Potomac, MD 20878-4305
(P) 301-424-2806
(F) 301-424-8563
Email: harold.at.arishel.com
Website: www.arishel.com
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The following message was posted to: PharmPK
Hi Harold - or (James?) Clerk Maxwell ;-)
>Could anyone please provide the batch size requirements for both new
>drugs as well as generics. I think this might be the standard below,
>but I am unsure. I could not find anything in the Oct 2000 guideline
>for oral drugs. Please advise.
>
<>
Which guideline are you referring to - if there is one out there from
Oct 2000 please send me a note, so I can update my collection.
http://bebac.at/Guidelines.htm
>"The test batch or lot should be manufactured under production
>conditions and should be at least 10% of the size of the largest lot
>planned for full production, or a minimum of 100,000 units, whichever
>is larger."
>
<>
OK, this comes from the current European Guideline (July 2001)
http://www.emea.eu.int/pdfs/human/ewp/140198en.pdf<>
best regards,
Helmut
--
Helmut Schuetz
BEBAC
Consultancy Services for Bioequivalence and Bioavailability Studies
Neubaugasse 36/11
1070 Vienna/Austria
tel/fax +43 1 2311746
http://BEBAC.at
Bioequivalence/Bioavailability Forum at http://forum.bebac.at
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