taiyab.jameel
☆    

India,
2020-03-05 09:02
(231 d 08:08 ago)

Posting: # 21205
Views: 4,471
 

 Test samples expired for FED study [Regulatives / Guidelines]

Hello,

We have conducted Fasting BE study for Pantoprazole Sodium delayed release tablets from CRO.

As we are filing products in regulated market we have to performed Fed study as per EMEA & FDA guidelines.

Now problem is our Test samples are expired but RLD expiry renaming for next 8 months.

How can we conduct fed study. What are the challenges we can face after filing.
jag009
★★★

NJ,
2020-03-05 20:57
(230 d 20:13 ago)

@ taiyab.jameel
Posting: # 21211
Views: 2,705
 

 Test samples expired for FED study

Hi
» How can we conduct fed study. What are the challenges we can face after filing.

Can you make another batch?
J
taiyab.jameel
☆    

India,
2020-03-06 03:15
(230 d 13:55 ago)

@ jag009
Posting: # 21213
Views: 2,702
 

 Test samples expired for FED study

» Can you make another batch?

yes we can make another batch, is it acceptable fast and fed study performed on different batch of test product.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-03-06 10:21
(230 d 06:49 ago)

@ taiyab.jameel
Posting: # 21218
Views: 2,674
 

 Different batches

Hi Taiyab,

» […] is it acceptable fast and fed study performed on different batch of test product.

Why not?

Dif-tor heh smusma 🖖
Helmut Schütz
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The quality of responses received is directly proportional to the quality of the question asked. 🚮
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taiyab.jameel
☆    

India,
2020-03-06 11:26
(230 d 05:44 ago)

@ Helmut
Posting: # 21219
Views: 2,646
 

 Different batches

Thank you everyone for your kind comments.

We will do fed study on different batch of test sample for Generic filing.

Can we expect any query on authority or specific requirement, we need to met before study initiation.
Marcelo Davanco
☆    
Homepage
Campinas, SP, Brazil,
2020-03-06 11:37
(230 d 05:33 ago)

@ taiyab.jameel
Posting: # 21220
Views: 2,662
 

 Different batches

» Can we expect any query on authority or specific requirement, we need to met before study initiation.

In my opinion, it's important only to send a justification letter (considering expiry date of the Fasting condition batches) following the Fed condition BE reports in order to avoid further authority concerns.


Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post #5[Helmut]

Marcelo Davanço
wienui
★    

Germany, Oman,
2020-03-07 15:10
(229 d 02:00 ago)

(edited by wienui on 2020-03-07 16:56)
@ Marcelo Davanco
Posting: # 21222
Views: 2,591
 

 Different batches

Hi All,

» In my opinion, it's important only to send a justification letter (considering expiry date of the Fasting condition batches) following the Fed condition BE reports in order to avoid further authority concerns.

Why send a justification which is not needed?

It is nothing against to use a different batch's for different studies for the the same drug.

Best regards,

Cheers,
Osama
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2020-03-07 21:04
(228 d 20:06 ago)

@ wienui
Posting: # 21223
Views: 2,540
 

 The soft-spoken voice of reason

Hi Osama,

» Why send a justification which is not needed?

THX!

Dif-tor heh smusma 🖖
Helmut Schütz
[image]

The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Marcelo Davanco
☆    
Homepage
Campinas, SP, Brazil,
2020-03-07 23:32
(228 d 17:38 ago)

@ wienui
Posting: # 21224
Views: 2,515
 

 Different batches

Hi Osama,

» Why send a justification which is not needed?
»
» It is nothing against to use a different batch's for different studies for the the same drug.

I agree with you. It was just a suggestion based on our previous experience in Brazil :-|. Sometimes we need to explain the inexplicable to health authority to avoid delays in the dossier review :-D

BR,
Marcelo
wienui
★    

Germany, Oman,
2020-03-08 09:19
(228 d 07:51 ago)

@ Marcelo Davanco
Posting: # 21225
Views: 2,463
 

 Different batches

Hi Marcelo,

» I agree with you. It was just a suggestion based on our previous experience in Brazil :-|. Sometimes we need to explain the inexplicable to health authority to avoid delays in the dossier review :-D

The use of a different batch in the fed study as asked above from taiyab.jameel could be better as you can prove batches therpeutic equivalence consistency via in vivo studies.

On the contrary, in the case of additional strength biowaiver, it is a must to use the same biobatch for which the therpeutic equivalence was proven before via in vivo BE study.

Best regards,

Cheers,
Osama
ElMaestro
★★★

Belgium?,
2020-03-05 21:27
(230 d 19:43 ago)

@ taiyab.jameel
Posting: # 21212
Views: 2,683
 

 Test samples expired for FED study

Hi,

» How can we conduct fed study. What are the challenges we can face after filing.

Retest, extend the shelf life if within specs, release for CT?

I could be wrong, but...

Best regards,
ElMaestro

No, of course you do not need to audit your CRO if it was inspected in 1968 by the agency of Crabongostan.
Dr_Dan
★★  

2020-03-11 10:39
(225 d 06:31 ago)

@ ElMaestro
Posting: # 21239
Views: 2,117
 

 Test samples expired for FED study

Hi

» Retest, extend the shelf life if within specs, release for CT?

Right, this is exactly what is also done in phase III trials. But if you use another Test batch you can simply explain this in the clinical overview module 2.5 of the dossier.

Kind regards and have a nice day
Dr_Dan
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