Tina
★    

India,
2014-05-13 18:30
(4033 d 04:30 ago)

Posting: # 12938
Views: 4,826
 

 Expiry of IMPs + storage of bio­samples [Bioanalytics]

Dear forum members,

If the clinical phase of bioequivalence study is conducted before the date of expiry while the bioanalytical phase is carried for 3 months post-expiry of the product, will there be any interference with the bioanalytical values?

Kind regards,
Tina


Edit: Subject line changed. [Helmut]
Helmut
★★★
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Vienna, Austria,
2014-05-13 18:58
(4033 d 04:01 ago)

@ Tina
Posting: # 12939
Views: 4,117
 

 Expiry of IMPs + storage of bio­samples

Hi Tina,

no problem – if validation of long-term stability covers the time period from first administration to the end of analyses. Hint: The IMPs were administered within their shelf-lives. Out of curiosity: Why do you wait 3+ months to get the samples analyzed?

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ElMaestro
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Denmark,
2014-05-13 19:08
(4033 d 03:52 ago)

@ Helmut
Posting: # 12940
Views: 4,055
 

 Easy...

Hi Hötzi,

❝ Out of curiosity: Why do you wait 3+ months to get the samples analyzed?


Otherwise all the waiting during validation would have been completely in vain...:-D

Pass or fail!
ElMaestro
Tina
★    

India,
2014-05-13 20:04
(4033 d 02:56 ago)

@ Helmut
Posting: # 12941
Views: 4,108
 

 Expiry of IMPs + storage of bio­samples

Thanks Helmut.

Bioanalysis took a long time as sample size was 102. Additionally the CRO's HPLC machines werent available to run analysis immediately after the clinical phase.

Kind regards,
Tina
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