nlpati
☆    

India,
2018-02-19 11:10

Posting: # 18433
Views: 3,234
 

 Shortage of retention quantity [Study Per­for­mance]

Dear Sir/ Madam,

If we have conducted fed and fasting study in one site and the sponsor wants to continue the study with remaining IPs in another site with the same test and reference in which there is shortage of any of the IPs. For example if sufficient amount of test is not available in required quantity (for retention) for upcoming study. Can we proceed with new shipment of IPs provided by sponsor as second shipment (in which only 1 container will be provided for conduct of study) only for the conduct of study and considering the retention samples from first shipment. Kindly provide your opinion regarding this scenario. Also kindly opine whether this single container can be used for study or need to be retained as retention sample with out using for the study.


Edit: Category changed; see also this post #1. [Helmut]
Ohlbe
★★★

France,
2018-02-19 11:43

@ nlpati
Posting: # 18434
Views: 2,936
 

 Retention samples

Dear nlpati,

Is your study for USFDA submission ? If it is: is anything unclear in the FDA guidance, which you can find on the BEBAC guidance page ?

Regards
Ohlbe
nlpati
☆    

India,
2018-02-22 08:06
(edited by Ohlbe on 2018-02-22 10:03)

@ Ohlbe
Posting: # 18444
Views: 2,660
 

 Retention samples

Yes it is an USFDA submission


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! [Ohlbe]
Helmut
★★★
avatar
Homepage
Vienna, Austria,
2018-02-19 12:44

@ nlpati
Posting: # 18435
Views: 2,954
 

 ‘Add-on’ design?

Hi Nlpati,

» If we have conducted fed and fasting study in one site and the sponsor wants to continue the study with remaining IPs in another site with the same test and reference…

I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed?
  • If the study was already assessed for BE (with 90% CIs), the entire α is already spent. Such an ‘Add-on’ inflates the patient’s risk and fortunately is only acceptable in Japan (rightly went into the statistical waste-can in all other jurisdictions).
  • Even if you post hoc try to transform the study into a Two-Stage design, I have some doubts whether this is a statistically valid approach.

PS: Your e-mail address is not valid any more. Please either change it or uncheck the e-mail notification box in future posts.

Cheers,
Helmut Schütz
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jag009
★★★

NJ,
2018-02-21 20:24

@ Helmut
Posting: # 18440
Views: 2,765
 

 ‘Add-on’ design?

Helmut!
I think he meant to run new studies and wanted to transfer IPs from the completed studies etc etc... I think...
John
nlpati
☆    

India,
2018-02-22 08:12
(edited by Ohlbe on 2018-02-22 10:02)

@ Helmut
Posting: # 18445
Views: 2,692
 

 ‘Add-on’ design?

Hi Helmut,

» I don’t understand. The study is completed and the sponsor wants to increase the sample size – because the study failed?

Study is completed and wants to do additional study with some additional subjects and planning to retrieve IPs from previous passed study. For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.

with regards,
Lakshmipathy


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! [Ohlbe]
Ohlbe
★★★

France,
2018-02-22 10:19

@ nlpati
Posting: # 18446
Views: 2,616
 

 Homework

Dear Lakshmipathy,

» For test they are using old IPs and reference they are getting new IPs of same batch for the conduct of study. Our doubt is whether we have to have retention quantity for both old study and new study.

Then I will ask the same question again: what exactly do you not understand in section IV of the FDA guidance ? Did you read it carefully ? What is your opinion ?

Regards
Ohlbe
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