pravin17
★    

India,
2014-03-25 06:34
(4481 d 10:44 ago)

Posting: # 12699
Views: 3,163
 

 In-Vitro study [Regulatives / Guidelines]

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Dear Sir,

As per USFDA OGD recomendation only Invitro study is require to be submitted, whether there any specific requirment in final study report or it is same as regular (E3 format).

Thank You
Pravin
 
Dr_Dan
★★  

Germany,
2014-03-25 10:10
(4481 d 07:09 ago)

@ pravin17
Posting: # 12701
Views: 2,615
 

 In-Vitro study

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Dear Pravin
the E3 format refers to clinical studies i.e. in vivo and would not be applicable for an in vitro study.
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan
 
pravin17
★    

India,
2014-03-25 13:51
(4481 d 03:27 ago)

@ Dr_Dan
Posting: # 12705
Views: 2,587
 

 In-Vitro study

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Dear Dr Dan,

Please guide me-how report should be prepared, is there any specific guidline for In-vitro studies.

Thank You
Pravin
 
Dr_Dan
★★  

Germany,
2014-03-26 09:37
(4480 d 07:41 ago)

@ pravin17
Posting: # 12713
Views: 2,540
 

 In-Vitro study

Post reply
Dear Pravin
As far as I know there is no specific guideline. I suggest to prepare the report more or less like a scientific publication:
  • Title page
  • Synopsis
  • Administrative structure
  • QA Statement
  • Signatures
  • Introduction
  • Material and methods
  • Results
  • Discussion and conclusion
  • References
  • Appendices
    1. protocol
    2. method validation report
    3. raw data
    4. certificates
      etc.
I hope this helps
Kind regards
Dr_Dan
—
Kind regards and have a nice day
Dr_Dan
 
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