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Dear All
I am new to this site. I have recently started working on Regulatory
submission which needs BE studies( Generic ). Do we have to do both
fasting and fed studies? Can anybody guide me regarding glossary for
Bioequivalence related terms.
Best Regards
Meera.K
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The following message was posted to: PharmPK
Dear Meera:
A good place is FDA Guidance for Industry . Bioavailbility and
bioequivalence studies... I am assuming you are dealing with oral
generic, in which case you will have to look up the standard drug
insert. The standard can be found in the orange book.
http://www.fda.gov/cder/ob/
Vuong
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The following message was posted to: PharmPK
Here's a link that should help.
http://www.fda.gov/cder/guidance/5356fnl.doc
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Hello All
We have solubility problems with our Oxazolidinone family of compound
and i want to try in Cyclodextrins. Could any one please tell me where
can i get Sulfo butyl ether cyclodextrin ? ( SBECD) . I searched
Aldrich, Fluka and sigma chemicals. or Could any one tell the better
solvent to dissolve the OXAZOLIDINONE based compounds ?
Thanks !
Sreekanth Gutala Ph.D.
Scientist
Bexel Pharmaceuticals Inc
32990 Alvarado Niles Road
Suite 910, Union City
CA 94587, USA
sgutala.-a-.hotmail.com
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