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RegisterInvestigational Products for BA/BE [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2005-10-19 13:22 (6758 d 01:27 ago) – Posting: # 43
Views: 20,231
Hi!
'Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format' (Draft Guidance, 2004-05-12) states:
Retention of Samples
It is recommended that samples of the test and reference drug products used in the comparative bioavailability study(ies), and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn.
'Preparation of Comparative Bioavailability Information for Drug Submissions in the CTD Format' (Draft Guidance, 2004-05-12) states:
Retention of Samples
It is recommended that samples of the test and reference drug products used in the comparative bioavailability study(ies), and the biological samples collected, including QC samples, be retained until the submission is either cleared or withdrawn.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- Investigational Products for BA/BE debabrata 2005-10-19 06:58 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Investigational Products for BA/BEHelmut 2005-10-19 11:22
- Investigational Products for BA/BE debabrata 2005-10-20 07:22
- Investigational Products for BA/BE H_Rotter 2005-10-20 15:43
Ing. Helmut Schütz