Dear Jim, Peter and Malcolm,
Thank you for your comprehensive answers and directions. They are
very helpful. I am impressed!
Please find below link to Regulatory Library website. This archive
FDA document, mentioned by Mr. Malcolm Ross, concerning stability
issues can be found here:
http://www.biologicsconsulting.com/guidancedocuments_all.htm
Thank you all of you for interesting discussion.
Kind Regards
Aleksandra
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Aleksandra
aleksandra.zaborska@neostrada.pl
Pharmaceutical Company
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