soma pillai
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2009-08-10 11:43
(6156 d 16:23 ago)

Posting: # 4025
Views: 5,938
 

 Failure in preparation of IPs [GxP / QC / QA]

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Dear all,

How one can know whether any BA/BE study fails due to error in formulation preparation ?

Regards,

Soma Pillai

Edit: Category and subject line changed. Please try to be more specific in the future! [Helmut]
 
Helmut
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Vienna, Austria,
2009-08-10 19:36
(6156 d 08:30 ago)

@ soma pillai
Posting: # 4033
Views: 4,564
 

 cGMP prerequisite of BE!

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Dear Soma!

❝ How one can know whether any BA/BE study fails due to error in formulation

❝ preparation ?


Oops! I hope you are talking about a (few) suspected case(s) in a study.
Conformity with cGMP is a prerequisite of BE! You may suspect anything, but:
  • If you are able to track down an error in the preparation of IPs, fine, but I would expect your chances to remove these suspects after the study was unblinded and evaluated to be very low.
  • If you don't find the error (=documented: no oral lore!), your chances are close to nil.
In either case it casts a damning light on the conformity with cGMPs. Even if the study is accepted - which I don't believe - prepare for a thorough cGMP/GCP inspection soon.
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