Bioequivalence and Bioavailability Forum

Guideline # guidance [Tips / Tricks]

posted by Helmut  – Vienna, Austria, 2013-05-29 01:27 (4754 d 18:54 ago) – Posting: # 10679
Views: 19,985

Hi John,

❝ Guideline is cast in stone.

I see. As a cave diver I’m familiar with guidelines. No discussion about their necessity.

❝ […] Drug Master File Guideline

“IV.D.4. […] The submitter should punch holes 8 1/2 inches apart in each page.”

Makes sense.

If I understand this list correctly this guideline [sic] is still in force:

“The data analyses should include appropriate statistical analyses involving Analysis of Variance, calculations of power analysis, 95% confidence intervals, and ratio analysis (75/75–125 Rule).”

What the heck?

❝ Regarding draft BA/BE guidances... […] I think majority of them (I looked at some as far back as 2008) are still in draft.

2008? That’s nothing. Have a look at this goody’s date.

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


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Complete thread:

• Differences Irukulla Shravan Kumar 2013-05-28 06:00 
  • Hard and soft law Helmut 2013-05-28 14:22
  • Differences ElMaestro 2013-05-28 14:37
    • John, are you there? Helmut 2013-05-28 14:56
      • John, are you there? jag009 2013-05-28 21:12
        • Guideline # guidanceHelmut 2013-05-28 23:27
          • Guideline # guidance jag009 2013-05-30 16:08
            • As time passes by Helmut 2013-05-30 17:59
              • As time passes by jag009 2013-05-31 15:15