Dear Forum members,
I have two questions about which I could not find clear information in the
official guidelines relevant with bioequivalencey testing of generic
produts.
1- If one generic product bioequivalency test had already been
conducted reference to original product and if you want to change active
ingredient source which trials are compulsory to prove that the previous
bioequivalency results are still valid ?
· If both sources have Certificate of Suitability to European
Pharmacopoeia monographs, are these documents sufficient to exclude further
trials?
· If sources do not have CoS or there is no monograph in the
Pharmacopoeias, are in-vitro dissolution profile trials sufficient?
· Under which conditions repeating bioequivalency study is required?
What is the practical situation in the EU countries and USA?
2- If two generic product manufacturers have an agreement to develop a
tablet formula together and provide the active and inactive ingredients
from the same sources is there any objection to conduct one bioequivalency
trial for two manufacturers?
Every parameters of the products will be the same except the manufacturing
areas but same kind of machinery will be used for industrial
manufacturing.
If one bioequvalency testing is approved instead of two trials by the
regulatory bodies what type of dossier should be prepared by the
bioequivalence center who conducts the trial. Can they write the name of
the two manufacturers on the same dossier together with brief explanation
of the purpose.
Is this type of bioequivalency trial acceptable by the regulatory
authorities?
Your kind response for the above situations will be highly appreciated.
FERHAN AKTAN
Mustafa Nevzat İlaç Sanayii A.S
ferhan_aktan@mn.com.tr
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