Bioequivalence and Bioavailability Forum • As short as possible

As short as possible [GxP / QC / QA]

posted by Helmut – Vienna, Austria, 2012-06-19 17:25 (4707 d 14:19 ago) – Posting: # 8792
Views: 9,111

Dear Kaushik!

❝ I want your opinion regarding Mr. Ohlbe's post.

Totally agree with Ohlbe (as you might have read between the lines in my first post). Think about the tighter limits set by European CROs despite a much lower incidence rate of TB and other infectious diseases (latency period!) than in India. If the lab exam was done four weeks before the first administration a physical exam at hospitalization might not show anything abnormal.
Don’t jeopardize the health of volunteers – revise your SOP!

—
Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz

The quality of responses received is directly proportional to the quality of the question asked. 🚮
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Complete thread:

volunteers lab data validity period kaushik089 2012-06-15 08:17
- As short as possible Helmut 2012-06-16 15:46
  - As short as possible kaushik089 2012-06-18 06:00
    - As short as possible drgunasakaran1 2012-06-18 06:49
    - As short as possible Ohlbe 2012-06-18 11:49
      - As short as possible kaushik089 2012-06-19 06:23
        
        As short as possibleHelmut 2012-06-19 15:25
        
        As short as possible kaushik089 2012-06-20 05:39
        
        As short as possible Helmut 2012-06-20 14:11